law questions

The 2016 CDC guideline for prescribing opioids suggests to reassess the evidence of "individual benefit and risk" when increasing daily dose to above ____ morphine milligrams equivalent per day. a. 30 b. 50 c. 90 d. 120

Answer(b): The 2016 CDC guideline for prescribing opioids suggests to reassess the evidence of "individual benefit and risk" when increasing daily dose to above 50 morphine milligrams equivalent per day, and avoidance of doses greater than 90 MME per day.

Minnesota Pharmacies Could Take Back Prescription Medicines Under Proposed Legislation.

Pharmacies in Minnesota would be able to collect and dispose of controlled substances (CS) and non-CS under a proposed bill (Senate File (SF) 1425). Currently, it is unlawful for Minnesota pharmacies to take back prescription drugs, reports American Pharmacists Association. The companion bill to SF 1425 is House File 1503. To date, the proposed bill was referred to the Committee on Health, Human Services and Housing for a second reading.

The patient profile record shall contain which of the following? I. name, address, telephone number of the patient. II. the quantity of drug and date filled prescription received by the patient. III. disease state of the patient a. I only b. I and II only c. II and III only d. All

nswer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3110 Subpart 2]. A reasonable effort must be made by the pharmacy to obtain, record, and maintain at least the following information regarding individuals obtaining prescription services at the pharmacy: A. name, address, telephone number, date of birth or age, and gender; B. individual history where significant, including disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices being used showing the prescription number, the name and strength of the drug or device, the quantity and date received by the patient, and the name of the prescriber; if this information is obtained by someone other than the pharmacist, the pharmacist must review the information with the patient; and C. pharmacist comments relevant to the individual's drug therapy, including, where appropriate, documentation of the following for each prescription: (1). the pharmaceutical care needs of the patient; (2). the services rendered by the pharmacist; and (3). the pharmacist's impression of the patient's drug therapy. This documentation is not required for residents of a licensed nursing home where a consultant pharmacist is performing regular drug regimen reviews.

Changes in any information in the name and title of corporate officer or director of a wholesale drug distributor shall be submitted to the board within: a. 30 days of the change b. 60 days of the change c. 90 days of the change d. 120 days of the change

Answer: (a) 30 days of the change, [Minnesota Administrative Rules Chapter 6800 Sec.6800.1410]. The following information is required from each wholesale drug distributor applying for licensure or renewal: A. the name, full business address, and telephone number of the licensee; B. all trade or business names used by the licensee; C. addresses, telephone numbers, and the names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of drugs; D. whether the ownership or operation is a partnership, corporation, or sole proprietorship; and E. the name of the owner and operator of the licensee, including: (1). if an individual, the name of the individual; (2). if a partnership, the name of each partner, and the name of the partnership; (3). if a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the state of incorporation; and (4). if a sole proprietorship, the full name of the sole proprietor, and the name of the business entity. Changes in any information in items A to E shall be submitted to the board within 30 days of the change.

A 45-year-old patient comes to a pharmacy and presents a prescription for Ambien written by his podiatrist. A pharmacist shall: a. Not fill the prescription. b. Fill the prescription. c. Ask the patient to get a new prescription. d. Fill and dispense the prescription after filling a DEA 222 order form.

Answer: (a) A pharmacist shall not fill the prescription, [21CFR1306.04(a)]. For a controlled substance prescription drug order to be legal, it must be issued for a legitimate medical purpose by an authorized individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing of controlled substances is upon the prescribing practitioner, but the pharmacist is responsible for the proper filling of the prescription drug order. A registered physician, dentist, veterinarian, or podiatrist authorized by this state to prescribe controlled substances can issue a prescription for controlled substances only in the usual course of his or her professional practice. Therefore, a pharmacist shall question the prescription for sleeping pill (Ambien) prescribed by a registered podiatrist.

A 45-year-old patient comes to the pharmacy and presents a prescription for Ambien written by his podiatrist. A pharmacist shall: a. not fill the prescription. b. fill the prescription. c. ask the patient to get a new prescription from an authorized prescriber. d. fill Ambien only after filling out a DEA 222 order form.

Answer: (a) A pharmacist shall not fill the prescription, [Minnesota Pharmacy Practice Act 151.37, Subdivision 2 and 3]. For a controlled substance prescription drug order to be legal, it must be issued for a legitimate medical purpose by an authorized individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing of controlled substances is upon the prescribing practitioner, but the pharmacist is responsible for the proper filling of the prescription drug order. A registered physician, dentist, veterinarian, or podiatrist authorized by this state to prescribe controlled substances can issue a prescription for controlled substances only in the usual course of his or her professional practice. Therefore, a pharmacist shall question the prescription for sleeping pill prescribed by a registered podiatrist.

Which of the following hazardous drugs is also considered as the hazardous waste by EPA? a. Cyclophosphamide b. Paclitaxel c. Thiotepa d. Hydroxyurea

Answer: (a) Cyclophosphamide. Remember, hazardous drugs must be safely handled and disposed of; but, they are not necessarily disposed of as hazardous waste. There are nine hazardous drugs that are also listed as hazardous waste by EPA. 1. Arsenic trioxide is a P-listed hazardous waste. 2. Chlorambucil, cyclophosphamide, daunorubicin HCI, diethylstilbestrol, melphalan, mitomycin, streptozocin, and uracil mustard are U-listed hazardous wastes.

After dispensing an emergency Schedule II drug, the pharmacist has to contact which of the following upon not receiving a written prescription from the prescriber within 7 days? I. The DEA Office II. The patient III. The State Board of Pharmacy a. I only b. I and II only c. II and III only d. All

Answer: (a) DEA office, [Minnesota Administrative Rules Chapter 6800 Sec.6800.6200 Subpart 3(A),(B),(C), Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.11 Subdivision 1a and 21CFR1306.11(d)(1-to-4)]. After dispensing an emergency Schedule II drug, the pharmacist shall contact the DEA office upon not receiving a written prescription from the prescriber within 7 days of an emergency oral authorization. (Note: section 152.11 Subdivision 1a of Minnesota Pharmacy Law indicates the dispensing of schedule II controlled substance in emergency situation should be based on Federal Regulation)

A pharmacy technician registration expires each year on: a. December 31 b. June 30 c. November 30 d. July 31

Answer: (a) December 31, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3850 Subpart 1b(A)]. A pharmacy technician registration expires each year on December 31 and shall be renewed annually by filing an application for registration renewal on or before December 1 of each year.

If the registration of any purchaser is suspended or revoked for handling the controlled substances listed in Schedule I or II or both, the purchaser must return all unused DEA Forms 222 to the: I. Nearest office of the DEA II. HCFA III. State Board of Pharmacy a. I only b. I and II only c. II and III only d. All

Answer: (a) I only, [21CFR Section 1305.18]. If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser's registration) or is suspended or revoked for all Schedule I and II controlled substances for which the purchaser is registered, the purchaser must return all unused DEA Forms 222 to the nearest office of the DEA.

Which of the following information is/are TRUE ABOUT preserving DEA 222 forms? I. DEA Forms 222 must be maintained separately from all other records of the registrant. II. The purchaser must retain Copy 1 of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached. III. The supplier must retain Copy 3 of each DEA Form 222 that it has filled. a. I only b. I and II only c. II and III only d. All

Answer: (a) I only, [21CFR1305.17]. (a). The purchaser must retain Copy 3 (not copy 1) of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached. (b). The supplier must retain Copy 1 (not copy 3) of each DEA Form 222 that it has filled. (c). DEA Forms 222 must be maintained separately from all other records of the registrant. DEA Forms 222 are required to be kept available for inspection for a period of two years. If a purchaser has several registered locations, the purchaser must retain Copy 3 of the executed DEA Form 222 and any attached statements or other related documents (not including unexecuted DEA Forms 222, which may be kept elsewhere under §1305.12(e)), at the registered location printed on the DEA Form 222. (d). The supplier of thiofentanyl, carfentanil, etorphine hydrochloride, and diprenorphine must maintain DEA Forms 222 for these substances separately from all other DEA Forms 222 and records required to be maintained by the registrant.

What are Board approved continuing education providers for a pharmacist? I. ACPE II. CME-I III. CME-II a. I only b. I and II only c. II and III only d. All

Answer: (a) I only, [Minnesota Administrative Rules Chapter 6800 Sec.6800.1500 SubPart 1(B)]. "Approved provider" means any association, corporation, educational institution, organization, group, or person who has been recognized by the Board of Pharmacy as having met its criteria indicative of the ability to provide quality continuing education programs or who has been recognized by the board as being approved by the Accreditation Council for Pharmacy Education (ACPE) for the provision of quality continuing education programs.

A dispenser is NOT required to submit the data to Board for those controlled substance prescriptions dispensed for: I. a drug is distributed through the use of an automated drug distribution system to individuals residing in a health care facility. II. individuals receiving end-of-life care. III. individuals receiving medication intravenously. a. I only b. I and II only c. II and III only d. All

Answer: (a) I only, [Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.126 Subdivision 4,(c)]. A dispenser is not required to submit data for those controlled substance prescriptions dispensed for: (1). a drug is distributed through the use of an automated drug distribution system to individuals residing in a health care facility; (2). Individuals receiving a drug sample that was packaged by a manufacturer and provided to the dispenser for dispensing as a professional sample. A dispenser must provide to the patient for whom the prescription was written a conspicuous notice of the reporting requirements of this section and notice that the information may be used for program administration purposes.

Which of the following requires a DEA 222 form for purchase? a. Marijuana b. Pemoline c. Modafinil d. Clonazepam

Answer: (a) Marijuana is classified as Schedule I controlled drug, [Minnesota Administrative Rules Chapter 6800 Sec.6800.4210]. It requires a DEA 222 order form for purchase.

What will be the earliest date Dr. Naik may apply for re-registration if his DEA license expires on July 3, 2018? a. May 3, 2018 b. April 3, 2018 c. February 3, 2018 d. January 3, 2018

Answer: (a) May 3, 2018 (60 days in advance) would be the earliest date Dr. Naik may apply to renew his DEA license, [21CFR1301.13(b)]. 21CFR1301.13(b): Any person who is registered may apply to be reregistered not more than 60 days before the expiration date of his/her registration.

VR came to your pharmacy and said that he could only pay for 30 tablets of Ritalin. The remaining he would collect next week. The pharmacist may tell him: a. Okay, but call us before you come. b. We cannot dispense this prescription. c. You have to pay us in advance for the whole supply. d. No, you cannot do that.

Answer: (a) Okay, but call us before you come, [21CFR1306.13(b)]. CARA 2016 amended the CSA to allow for the partial dispensing of a schedule II prescription if not prohibited by state law, requested by the patient or prescriber and the total quantity dispensed in partial fillings does not exceed the total quantity prescribed. 21 U.S.C. § 829(f)(1). The amended CSA prohibits further partial dispensing later than 30 days after the prescription is written and no later than 72 hours in emergency situations. 21 U.S.C. § 829(f)(2).

As a pharmacist you would like to buy drugs whose AAC are: a. Lower than their AWP. b. Greater than their AWP. c. Equal to their AWP. d. None of the above

Answer: (a) Pharmacists always prefer to buy drugs whose AAC (Actual Acquisition Cost) are lower than their AWP (Average Wholesale Price). AAC is defined as the actual price pharmacists pay when purchasing drugs. AWP is defined as the published wholesale price for drugs. AWP is generally used to determine prices of prescription drugs. Pharmacists prefer to buy drugs at lower price than their AWP.

To prepare a unit dose, single dose, unit of issue package, customized patient medication package, or traditional dispensing system package for dispensing pursuant to an existing order is commonly defined as a(n): a. Repackage b. Prepackage c. Unit dose package d. Unit of issue package

Answer: (a) Repackage. Customized patient medication package: a package that contains two or more drugs per compartment. Prepackage: To prepare a drug in a container for dispensing, prior to the receipt of an order. Such packaging may be in a unit dose, single dose, or unit of issue package for use in a unit dose dispensing system, in a container suitable for a traditional dispensing system, or in a customized patient medication package. *Repackage: To prepare a unit dose, single dose, unit of issue package, customized patient medication package, or traditional dispensing system package for dispensing pursuant to an existing order.* Sealed unit dose container: A container that holds the drug in a hermetically sealed compartment to reduce the drug's exposure to moisture, air, and tampering until the time of administration. Traditional dispensing system: A drug package system in which individual doses are not packaged in unit dose packages or unit of issue packages. Unit dose: A single dose of a drug in an individually sealed, labeled container ready for administration to a particular patient by the prescribed route at the prescribed time. Unit dose distribution system: A drug distribution system that is in a pharmacy outlet, hospital, or other healthcare facility and uses unit dose packages, or unit of issue packages, labeled in accordance with § 20:51:21:05 and preserves the identity of the drug until the time of administration. Unit dose package: An individual package that contains one single unit dose of a drug packaged by a manufacturer or a pharmacy and preserves the integrity and identity of the drug from the point of packaging to the point of administration. Unit of issue package: A package that provides multiple units of the same drug doses, each separated in a medication card or other specifically designed container.

A new cough syrup has been introduced in a market that contains Guaifenesin/Hydrocodone (100mg/10mg per 5ml). The syrup is available in 8 ounces glass bottle. What controlled schedule shall be assigned to this new cough syrup? a. Schedule II controlled drug b. Schedule III controlled drug c. Schedule IV controlled drug d. Schedule V controlled drug

Answer: (a) The new syrup should be classified as a schedule II-controlled drug, [http://www.nabp.net/news/dea-reschedules-hydrocodone-combination-products-as-schedule-ii]. Drug Enforcement Administration (DEA) has published its final rule rescheduling hydrocodone combination products from Schedule III to Schedule II in the Federal Register. The change imposes Schedule II regulatory controls and sanctions on anyone handling hydrocodone combination products, effective October 6, 2014. DEA first published the proposed rules in March 2014, in response to a Food and Drug Administration recommendation. DEA received almost 600 public comments regarding the proposed rules after they were published, with a small majority of the commenters supporting the change, a DEA press release notes. Therefore, the new cough syrup should be classified as a schedule II controlled substance.

A retail pharmacy may install and operate automated dispensing systems at long term care facilities. a. True b. False

Answer: (a) True, [21 CFR Section 1301.27]. (a). A retail pharmacy may install and operate automated dispensing systems at long term care facilities. No person other than a registered retail pharmacy may install and operate an automated dispensing system at a long-term care facility. (b). Retail pharmacies installing and operating automated dispensing systems at long term care facilities must maintain a separate registration at the location of each long-term care facility at which automated dispensing systems are located. If more than one registered retail pharmacy operates automated dispensing systems at the same long-term care facility, each retail pharmacy must maintain a registration at the long-term care facility. (c). A registered retail pharmacy applying for a separate registration to operate an automated dispensing system for the dispensing of controlled substances at a long-term care facility is exempt from application fees for any such additional registrations.

If a purchaser determines that an unfilled electronic DEA 222 order has been lost before or after receipt, the purchaser must provide, to the supplier, a signed statement containing the unique tracking number and date of the lost order and stating that the goods covered by the first order were not received through loss of that order. a. True b. False

Answer: (a) True, [21CFR 1305.26]. (a). If a purchaser determines that an unfilled electronic DEA 222 order has been lost before or after receipt, the purchaser must provide, to the supplier, a signed statement containing the unique tracking number and date of the lost order and stating that the goods covered by the first order were not received through loss of that order. (b). If the purchaser executes an order to replace the lost order, the purchaser must electronically link an electronic record of the second order and a copy of the statement with the record of the first order and retain them. (c). If the supplier to whom the order was directed subsequently receives the first order, the supplier must indicate that it is "Not Accepted" and return it to the purchaser. The purchaser must link the returned order to the record of that order and the statement.

A prescription that is prepared by an agent of prescribing practitioner with the signature of the prescribing practitioner on the prepared prescription can be filled by a registered pharmacist. a. True b. False

Answer: (a) True, [21CFR Section 1306.05(f)]. All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner. A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document (e.g., J.H. Smith or John H. Smith). Where an oral order is not permitted, paper prescriptions shall be written with ink or indelible pencil, typewriter, or printed on a computer printer and shall be manually signed by the practitioner. A computer-generated prescription that is printed out or faxed by the practitioner must be manually signed. A prescription may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations.

Under the CSA, the transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing between two INTERNET PHARMACIES is allowed. a. True b. False

Answer: (a) True, [21CFR Section 1306.09(c)]. (a). No controlled substance that is a prescription drug may be delivered, distributed, or dispensed by means of the Internet without a valid prescription. (b). In accordance with the Act, it is unlawful for any person to knowingly or intentionally fill a prescription for a controlled substance that was issued in a manner that constitutes dispensing by means of the Internet unless such person is a pharmacist who is acting in the usual course of his professional practice and is acting on behalf of a pharmacy whose registration has been modified under sections 1301.13 and 1301.19 of this chapter to authorize it to operate as an online pharmacy. (c). Any online pharmacy that participates in the transfer between pharmacies of prescription information must do so in accordance with the requirements of §§1306.15 and 1306.25 of this part.

Prescriptions for controlled substances listed in Schedule II may be transmitted from a retail pharmacy to a central fill pharmacy via facsimile. a. True b. False

Answer: (a) True, [21CFR Section 1306.15]. Prescription information may be provided to an authorized central fill pharmacy by a retail pharmacy for dispensing purposes. The following requirements shall also apply: (a). Prescriptions for controlled substances listed in Schedule II may be transmitted electronically from a retail pharmacy to a central fill pharmacy including via facsimile. The retail pharmacy transmitting the prescription information must: (1). Write the words "CENTRAL FILL" on the face of the original paper prescription and record the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal. For electronic prescriptions the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal must be added to the electronic prescription record. (2). Ensure that all information required to be on a prescription pursuant to Section 1306.05 of this part is transmitted to the central fill pharmacy (either on the face of the prescription or in the electronic transmission of information); (3). Maintain the original prescription for a period of two years from the date the prescription was filled; (4). Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common or contract carrier) and the name of the retail pharmacy employee accepting delivery. (b). The central fill pharmacy receiving the transmitted prescription must: (1). Keep a copy of the prescription (if sent via facsimile) or an electronic record of all the information transmitted by the retail pharmacy, including the name, address, and DEA registration number of the retail pharmacy transmitting the prescription; (2). Keep a record of the date of receipt of the transmitted prescription, the name of the pharmacist filling the prescription, and the date of filling of the prescription; (3). Keep a record of the date the filled prescription was delivered to the retail pharmacy and the method of delivery (i.e. private, common or contract carrier).

Dietary supplements containing ephedrine alkaloids are classified adulterated under the Federal Food, Drug, and Cosmetic Act. a. True b. False

Answer: (a) True, [21CFR119.1 and FFDC section 402(f)(1)(A)]. Dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling, or if no conditions of use are recommended or suggested in the labeling, under ordinary conditions of use. Therefore, dietary supplements containing ephedrine alkaloids are adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act.

Drug Addiction Treatment Act-Waived qualifying physician assistants can prescribe and dispense the opioid maintenance drug buprenorphine from their offices. a. True b. False

Answer: (a) True, [Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder]. In January 2018, DEA announced a deregulatory measure that will make it easier for residents of underserved areas to receive treatment for opioid addiction. Nurse practitioners and physician assistants can now become Drug Addiction Treatment Act-Waived qualifying practitioners, which gives them authority to prescribe and dispense the opioid maintenance drug buprenorphine from their offices.

A pharmacist shall not be required to counsel a patient or care giver when the patient or care giver refuses such consultation and such refusal is documented. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.0910 SubPart 2 (B) and 6800.2160]. Personal communication by the pharmacist is not required for inpatients of a hospital or other institution, such as a licensed nursing home, where other licensed health care professionals are authorized to administer the drugs, or where a patient or patient's agent or caregiver has expressed a desire not to receive the consultation. When a new filled prescription or a refilled prescription for which counseling is required is being mailed or delivered to the patient by common carrier or delivery services, the consultation must still be provided but may be accomplished by providing written information to the patient regarding the medication being dispensed and the availability of the pharmacist to answer questions, and through the provision of a toll-free phone number for long distance calls. A pharmacist shall not be required to counsel a patient or care giver when the patient or care giver refuses such consultation and such refusal is documented and shall be retained by the pharmacy for a period of at least two years.

The Continuing Education Advisory Task Force shall consist of not more than ten members. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.1600]. The Continuing Education Advisory Task Force shall consist of not more than ten members. Three members of the advisory task force shall be pharmacists designated by the Minnesota State Pharmaceutical Association, three members shall be pharmacists designated by the Minnesota Society of Hospital Pharmacists, two members shall be pharmacists designated by the College of Pharmacy of the University of Minnesota, and two members shall be designated by the board. The Continuing Education Advisory Task Force shall meet at least quarterly and shall annually elect a chair and vice chair from its membership. The executive director of the Board of Pharmacy shall act as secretary to the task force.

In Minnesota, no pharmacist shall be designated pharmacist-in-charge of more than one pharmacy. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.2400 SubPart 3]. No pharmacist shall be designated pharmacist-in-charge of more than one pharmacy. In the interest of public health, this requirement may be waived in the case of a pharmacist serving a hospital pharmacy on a part-time basis.

A licensed hospital may receive a pharmaceutical service from a licensed pharmacy on the premises by using an automated medication management system as its primary drug distribution system. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.2600]. 1. Nothing in Minnesota State Pharmacy Law prohibits a licensed hospital receiving pharmaceutical services from a licensed pharmacy on the premises from utilizing such a device in an emergency, after regular pharmacy hours, when the hospital's pharmacist has complete control over the monitoring of drug therapy, packaging, labeling, filling, record-keeping, and security of the drugs involved and of the device, and when the device is utilized in compliance with all other state and federal laws and regulations regarding the distribution of legend drugs. 2. In addition, nothing in this part prevents a licensed hospital, receiving pharmaceutical service from a licensed pharmacy on the premises, from using an automated medication management system as its primary drug distribution system if the system requires that drug orders are reviewed and released by a pharmacist before hospital nursing staff are allowed access to the drug.

In a hospital with a licensed pharmacy, drugs, devices, or other items dispensed for hospital inpatient use only may be returned to the pharmacy for reuse. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.2700 Subpart 1]. Pharmacists and pharmacies are prohibited from accepting from patients or their agents for reuse, reissue, or resale any drugs, prescribed medications, chemicals, poisons, or medical devices; except that in a hospital with a licensed pharmacy, drugs, devices, or other items dispensed for hospital inpatient use only, which have not left the span of control of the pharmacy, may be returned to the pharmacy for reuse or disposal in accordance with good professional practice.

A licensed pharmacist by use of a common carrier may pick up prescription drug orders or deliver filled prescriptions at the office or home of the prescriber. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3000 SubPart 1 A]. Restrictions on pickup or delivery of prescription drug orders or filled prescriptions: No licensed pharmacist shall participate in any arrangement or agreement whereby prescription drug orders or filled prescriptions may be left at, picked up from, accepted by, or delivered to any place of business not licensed as a pharmacy. Provided, however, that nothing in this part prohibits a licensed pharmacist or a licensed pharmacy, by means of its employee or by use of a common carrier, from picking up prescription drug orders or delivering filled prescriptions at the office or home of the prescriber, at the residence of the patient, or at the hospital or long-term care facility in which a patient is confined.

Under the Minnesota State Pharmacy Law, a pharmacy may employ the United States Postal Service to deliver a filled prescription directly to a patient. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3000 SubPart 1 B]. A pharmacy that employs the United States Postal Service or other common carrier to deliver a filled prescription directly to a patient must, based on the professional judgment of the pharmacist: (1). use adequate storage or shipping containers and shipping processes to ensure drug stability and potency. The shipping processes must include the use of appropriate packaging material and devices, according to the recommendations of the manufacturer or the United States Pharmacopeia Chapter 1079, in order to ensure that the drug is kept at appropriate storage temperatures throughout the delivery process to maintain the integrity of the medication; (2). use shipping containers that are sealed in a manner to detect evidence of opening or tampering; (3). develop and implement policies and procedures to ensure accountability, safe delivery, and compliance with temperature requirements. The policies and procedures must address when drugs do not arrive at their destination in a timely manner or when there is evidence that the integrity of a drug has been compromised during shipment. In these instances, the pharmacy must make provisions for the replacement of the drugs; and (4). provide for an electronic, telephonic, or written communication mechanism for a pharmacist, or a pharmacy intern working under the direct supervision of a pharmacist, to offer counseling to the patient. The patient must receive information indicating what the patient should do if the integrity of the packaging or medication has been compromised during shipment.

Under Minnesota Pharmacy Law, prescriptions faxed to the pharmacy by the patient are not to be filled or dispensed unless the patient presents an original prescription at the time of dispensing the drug. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3000 Subpart 2]. 1. For a pharmacy other than a hospital pharmacy that is transmitting solely within the institution, the procedures must provide for the identification of the person sending the prescription or drug order. 2. Unless the fax transmission is received on a machine generating a copy that is readily readable for at least five years, all fax transmissions of drug orders shall be followed up within 72 hours with the original hard copy of the order or the pharmacist shall reduce the order received by fax to writing that is of permanent quality. 3. Orders for Schedule II-IV controlled substances received by fax shall be handled according to the rules of the Federal Drug Enforcement Administration. 4. Prescriptions faxed to the pharmacy by the patient are not to be filled or dispensed. It can only be filled if the patient presents an original prescription at the time of dispensing the drug.

The practice of compounding a prescription drug order shall be performed only by a pharmacist, practitioner, or pharmacist-intern under the immediate and direct supervision of a pharmacist. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3100 Subpart 1]. The practice of compounding and dispensing a prescription drug order includes, but is not limited to, the following acts, which shall be performed only by a pharmacist, practitioner, or pharmacist-intern under the immediate and direct supervision of a pharmacist: A. determination of brands and suppliers; B. receipt of verbal prescription drug orders which must include documentation of the individual communicating the order and the pharmacist or pharmacist intern receiving the order; C. verification of the prescription drug order; D. selection of the drug to be used in filling the prescription drug order; E. establishment and validation of the initial formulation record of all compounded preparations; F. certification of the filled prescription drug order; G. supervising clerical personnel in limited nonprofessional duties such as typing that does not involve prescription data entry, record keeping, filing, and completing sales transactions; and H. supervising pharmacy technicians utilized in the performance of certain pharmacy tasks not requiring professional judgment.

According to Minnesota State Pharmacy Law, a patient profile record must be maintained for a period of not less than two years from the date of the last entry in the profile record. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3110 Subpart 5]. According to Minnesota State Pharmacy Law, a patient profile record must be maintained for a period of not less than two years from the date of the last entry in the profile record. A patient profile record system must be maintained in all pharmacies for persons for whom prescriptions are dispensed. The patient profile record system must be designed for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed medication at the time a prescription is presented for dispensing. One profile record may be maintained for all members of a family living at the same address and possessing the same family name. A pharmacist may rely on computerized medication profile review, provided that it includes all medication dispensed by the pharmacy for the patient during at least the preceding six months. The pharmacist-in-charge must develop procedures for handling alerts generated by the computerized medication profile review and include these procedures in the written procedures required under part 6800.3950. Only a pharmacist or a pharmacist-intern working under the immediate and direct supervision of a pharmacist may override the alerts.

A pharmacy must develop a list of high-alert compounded preparations for which a pharmacist shall certify that each component used in the compounding of the drug preparation has been accurately weighed, measured, or subdivided, as appropriate, at each stage of the compounding procedure. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3300 Subpart 6]. A pharmacy must develop a list of high-alert compounded preparations for which a pharmacist shall certify that each component used in the compounding of the drug preparation has been accurately weighed, measured, or subdivided at each stage of the compounding procedure. Subsequent stages of the compounding process may not be completed until such certification occurs.

A beyond-use date of not more than one year from the prepackaging date or the time remaining to the manufacturer's expiration date, whichever is less, shall be placed on every container of drugs prepackaged into prescription vials by the pharmacist. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3350 Subpart 1]. Prepackaged into prescription vials: A beyond-use date of not more than one year from the prepackaging date or the time remaining to the manufacturer's expiration date, whichever is less, shall be placed on every container of drugs prepackaged into prescription vials by the pharmacist. Unit-of-use and blister card packages: A beyond-use date of not more than one year from the packaging date or the time remaining to the manufacturer's expiration date, whichever is less, shall be placed on all unit-of-use and blister card packaging whether prepared by the pharmacist at the time of dispensing or prepared earlier in anticipation of the dispensing.

In cases where the physical characteristics of the immediate container of the medication do not permit full labeling, a partial label containing, at a minimum, the patient name and the prescription number may be placed on the container and the complete labeling applied to an appropriate outer container. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3400 SubPart 2] In cases where the physical characteristics of the immediate container of the medication do not permit full labeling, a partial label containing, at a minimum, the patient name and the prescription number may be placed on the container and the complete labeling applied to an appropriate outer container.

Selection of individual unit dose packaging for placement in individual patient containers, bins, compartments, or drawers may be performed by supportive pharmacy personnel. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3750 SubPart 8]. Selection of individual unit dose packaging for placement in individual patient containers, bins, compartments, or drawers is NOT DISPENSING under part 6800.3100, and may be performed by supportive pharmacy personnel. Dispensing occurs upon the certification of the accuracy of the selected unit dose packages, which shall be done by the pharmacist before the dose is delivered for administration to the patient.

Under Minnesota Pharmacy Law, a 72-hour supply of each of a maximum of 15 different oral pharmaceuticals may be stored in an emergency kit. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.6700 Subpart 2(A)]. 1. The drugs shall be limited to the extent possible to a 72-hour supply of any one emergency drug in either sealed ampules, vials, or prefilled syringes. If an emergency drug is not available in parenteral form, a supply in an alternate dosage form may be provided. 2. Notwithstanding these restrictions, if the quality assurance and assessment committee considers it necessary, up to a 72-hour supply of each of a maximum of 15 different oral pharmaceuticals, not counting oral antibiotics, restricted to therapeutic categories related to symptomatic patient distress or emergencies may be stocked. 3. An unlimited number of oral antibiotics may be stocked in 72-hour supplies of each. 4. Inclusion of other oral legend drugs is permissible only through the granting of a variance by the board. 5. Drugs in the supply shall be properly labeled, including expiration dates and lot numbers.

According to Minnesota State Pharmacy Law, the emergency kit shall not contain more than six single doses of any controlled substance narcotic analgesic. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.6700 Subpart 3]. ** Emergency kits may contain limited supplies of controlled substances only if: A. The controlled substances are supplied by a licensed pharmacy duly registered with the Federal Drug Enforcement Administration; B. The emergency kit is kept in a locked medicine room or medicine cabinet; D. The emergency kit does not contain more than six single doses of any controlled substance narcotic analgesic; E. The dispensing pharmacy keeps a complete record of each controlled substance stored in the emergency kit, including the name of the drug, the strength of the drug, and the number of doses provided; F. The facility keeps a complete record of the use of controlled substances from the kit for two years, including the patient's name, the date of use, the name of the drug used, the strength of the drug, the number of doses used, and the signature of the person administering the dose. Controlled substance stimulants in oral dosage forms may not be included in emergency kits. **Conflict information Minnesota Administrative Rules Chapter 6800 Sec.6800..8007 Subpart 4 C (4) ** (4) limited to drugs that are not controlled substances.

A licensed pharmacy in a hospital may utilize additional locations within the hospital without the necessity of securing additional licenses. a. True b. False

Answer: (a) True, [Minnesota Administrative Rules Chapter 6800 Sec.6800.7950] A licensed pharmacy in a hospital may utilize additional locations within the hospital without the necessity of securing additional licenses provided, however, that the pharmacist-in-charge of the hospital pharmacy informs the board of the location of each satellite and assumes professional responsibility for the practice of pharmacy and for staffing in each additional location.

The board may not issue or renew the license of pharmacist if IRS reported to the board that the applicant owes the state delinquent taxes in the amount of $500 or more. a. True b. False

Answer: (a) True, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.074, Subdivision 11]. The board may not issue or renew a license or registration if the commissioner of revenue notifies the board and the licensee or applicant for a license that the licensee or applicant owes the state delinquent taxes in the amount of $500 or more. The board may issue or renew the license or registration only if (1). the commissioner of revenue issues a tax clearance certificate, and (2). the commissioner of revenue or the licensee, registrant, or applicant forwards a copy of the clearance to the board. The commissioner of revenue may issue a clearance certificate only if the licensee, registrant, or applicant does not owe the state any uncontested delinquent taxes. "Delinquent taxes" do not include a tax liability if: (i). an administrative or court action that contests the amount or validity of the liability has been filed observed, (ii). the appeal period to contest the tax liability has not expired, or (iii). the licensee or applicant has entered into a payment agreement to pay the liability and is current with the payments.

Usually, the pharmacist may supervise no more than three pharmacy technicians at any given time. a. True b. False

Answer: (a) True, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.102 Subdivision 1 and 2]**. A pharmacy technician may assist a pharmacist in the practice of pharmacy by performing nonjudgmental tasks and works under the personal and direct supervision of the pharmacist. A pharmacist may supervise three technicians, as long as the pharmacist assumes responsibility for all the functions performed by the technicians. A pharmacy may exceed the ratio of pharmacy technicians to pharmacists permitted in this subdivision or in rule by a total of one technician at any given time in the pharmacy, provided at least one technician in the pharmacy holds a valid certification from the Pharmacy Technician Certification Board or from another national certification body for pharmacy technicians that requires passage of a nationally recognized, psychometrically valid certification examination for certification as determined by the Board of Pharmacy. The Board of Pharmacy may, by rule, set ratios of technicians to pharmacists greater than three to one for the functions specified in rule. The delegation of any duties, tasks, or functions by a pharmacist to a pharmacy technician is subject to continuing review and becomes the professional and personal responsibility of the pharmacist who directed the pharmacy technician to perform the duty, task, or function. **Conflict with Minnesota Administrative Rules Chapter 6800 Sec.6800.3850 SubPart 6 which sets pharmacist to technician ratio to two.** Section 6800.3850: The basic ratio of pharmacy technicians to pharmacists on duty in a pharmacy is two technicians to one pharmacist. Specific functions are excepted from the basic ratio as follows: A. intravenous admixture preparation, 3:1; B. setting up or preparing patient specific prescriptions in unit dose or modified unit dose packaging, 3:1; C. prepackaging, 3:1; and D. compounding, 3:1.

Under a Cancer Drug Repository program, a cancer drug repository may charge the individual receiving a drug or supply a handling fee of no more than 250 % of the medical assistance program dispensing fee for each cancer drug or supply dispensed or administered. a. True b. False

Answer: (a) True, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.55 Subdivision 7 to Subdivision 10]. 1. A Cancer Drug Repository may charge the individual receiving a drug or supply a handling fee of no more than 250 % of the medical assistance program dispensing fee for each cancer drug or supply dispensed or administered. 2. The Minnesota Board of Pharmacy shall establish and maintain a Cancer Drug Repository program, under which any person may donate a cancer drug or supply for use by an individual who meets the eligibility criteria specified under Minnesota Pharmacy Law. 3. Under the program, donations may be made on the premises of a medical facility or pharmacy that elects to participate in the program and meets the requirements specified under pharmacy law. 4. Cancer Drug Repository donor and recipient forms shall be maintained for at least five years.

Under Minnesota State Pharmacy Law, no person may sell in a single over-the-counter sale more than two packages of a methamphetamine precursor drug or a combination of methamphetamine precursor drugs or any combination of packages exceeding a total weight of six grams. a. True b. False

Answer: (a) True, [Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.02 Subdivision 6,(c)]. No person may sell in a single over-the-counter sale more than two packages of a methamphetamine precursor drug or a combination of methamphetamine precursor drugs or any combination of packages exceeding a total weight of six grams.

A prescriber may delegate the task of accessing the controlled substance monitoring data to an agent or employee of the prescriber. a. True b. False

Answer: (a) True, [Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.126 Subd 6]. The following persons shall be considered permissible users and may access the controlled substance monitoring data: (1). a prescriber or an agent or employee of the prescriber to whom the prescriber has delegated the task of accessing the data, to the extent the information relates specifically to a current patient, to whom the prescriber is: (i). prescribing or considering prescribing any controlled substance; (ii). providing emergency medical treatment for which access to the data may be necessary; (iii). providing care, and the prescriber has reason to believe, based on clinically valid indications, that the patient is potentially abusing a controlled substance; or (iv). providing other medical treatment for which access to the data may be necessary for a clinically valid purpose and the patient has consented to access to the submitted data, and with the provision that the prescriber remains responsible for the use or misuse of data accessed by a delegated agent or employee; (2). a dispenser or an agent or employee of the dispenser to whom the dispenser has delegated the task of accessing the data, to the extent the information relates specifically to a current patient to whom that dispenser is dispensing or considering dispensing any controlled substance and with the provision that the dispenser remains responsible for the use or misuse of data accessed by a delegated agent or employee; (3). a licensed pharmacist who is providing pharmaceutical care for which access to the data may be necessary to the extent that the information relates specifically to a current patient for whom the pharmacist is providing pharmaceutical care: (i). if the patient has consented to access to the submitted data; or (ii). if the pharmacist is consulted by a prescriber who is requesting data; (4). an individual who is the recipient of a controlled substance prescription for which data was submitted or a guardian of the individual, parent or guardian of a minor, or health care agent of the individual acting under a health care directive; (5). personnel or designees of a health-related licensing board or of the Emergency Medical Services Regulatory Board, assigned to conduct a bona fide investigation of a complaint received by that board that alleges that a specific licensee is impaired by use of a drug (6). personnel of the board engaged in the collection, review, and analysis of controlled substance prescription information as part of the assigned duties and responsibilities; (7). authorized personnel of a vendor under contract with the state of Minnesota who are engaged in the design, implementation, operation, and maintenance of the prescription monitoring program as part of the assigned duties and responsibilities of their employment, provided that access to data is limited to the minimum amount necessary to carry out such duties and responsibilities, and subject to the requirement of de-identification and time limit on retention of data; (8). federal, state, and local law enforcement authorities acting pursuant to a valid search warrant; (9). personnel of the Minnesota health care programs assigned to use the data collected to identify and manage recipients whose usage of controlled substances may warrant restriction to a single primary care provider, a single outpatient pharmacy, and a single hospital; (10). personnel of the Department of Human Services assigned to access the data; (11). personnel or designees of a health-related licensing board assigned to conduct a bona fide investigation of a complaint received by that board that alleges that a specific licensee is inappropriately prescribing controlled substances.

The pharmacist is not required to be physically present at the site of the automated drug distribution system if the system is continuously monitored electronically by the pharmacist of managing pharmacy. a. True b. False

Answer: (a) True, [Minnesota Pharmacy Act Chapter 151.58 Subdivision 5(c) to (e)]. (c)(1). A pharmacist employed by and working at the managing pharmacy must review, interpret, and approve all prescription drug orders before any drug is distributed from the system to be administered to a patient. A pharmacy technician may perform data entry of prescription drug orders provided that a pharmacist certifies the accuracy of the data entry before the drug can be released from the automated drug distribution system. A pharmacist must certify the accuracy of the filling of any cassettes, canisters, or other containers that contain drugs that will be loaded into the automated drug distribution system; and (2). when the automated drug dispensing system is located and used within the managing pharmacy, a pharmacist must personally supervise and take responsibility for all packaging and labeling associated with the use of an automated drug distribution system. (d). Access to drugs when a pharmacist has not reviewed and approved the prescription drug order is permitted only when a formal and written decision to allow such access is issued by the pharmacy and the therapeutics committee or its equivalent. The committee must specify the patient care circumstances in which such access is allowed, the drugs that can be accessed, and the staff that are allowed to access the drugs. (e). In the case of an automated drug distribution system that does not utilize bar coding in the loading process, the loading of a system located in a health care facility may be performed by a pharmacy technician, so long as the activity is continuously supervised, through a two-way audiovisual system by a pharmacist on duty within the managing pharmacy. In the case of an automated drug distribution system that utilizes bar coding in the loading process, the loading of a system located in a health care facility may be performed by a pharmacy technician or a licensed nurse, provided that the managing pharmacy retains an electronic record of loading activities. (f). The automated drug distribution system must be under the supervision of a pharmacist. The pharmacist is not required to be physically present at the site of the automated drug distribution system if the system is continuously monitored electronically by the managing pharmacy.

A contract pharmacist or pharmacy may repackage a Long-Term Care Facility resident's prescription drugs without obtaining a manufacturer's license. a. True b. False

Answer: (a) True, [Minnesota Pharmacy Practice Act 151.415]. A contract pharmacy means a pharmacy which is under contract to a long-term care facility. An Original dispensing pharmacy shall mean a pharmacy, licensed in any state in the United States, which dispenses drugs in bulk prescription containers to a person who is a resident in a long-term care facility. (a). A contract pharmacist or pharmacy may repackage a resident's prescription drugs, which have been lawfully dispensed from bulk prescription containers by an original dispensing pharmacy, into a unit-dose system compatible with the system used by the long-term care facility. (b). A long-term care facility may administer drugs to residents of the facility that have been repackaged according to this subdivision. The contract pharmacy shall notify the long-term care facility whenever medications have been dispensed according to this subdivision and must certify that the repackaging and dispensing has been done in accordance with this subdivision. (c). Drugs may be dispensed for a resident of a long-term care facility according to this subdivision, provided that: (1). the drug is dispensed by the original dispensing pharmacy according to a current, valid prescription; (2). the original bulk prescription container for the resident is delivered by the original dispensing pharmacy directly to the contract pharmacist or pharmacy; (3). the contract pharmacist or pharmacy verifies the name and strength of the drug, the name of the manufacturer of the drug, the manufacturer's lot or control number, the manufacturer's expiration date for the drug, and the date the drug was dispensed by the original dispensing pharmacy; (4). the contract pharmacist or pharmacy verifies the validity and accuracy of the current prescription order; (5). the contract pharmacist or pharmacy repackages the drug in board-approved unit-dose packaging, with labeling that complies with Minnesota Rules, part 6800.6300, and that identifies that the drug has been repackaged according to this section; (6).the resident for whom the medication is repackaged obtains medications from or receives medications at a discounted rate from the original dispensing pharmacy under the resident's state or federal health assistance program or a private health insurance plan; and (7). the resident for whom the medication is to be repackaged, or the resident's authorized representative, has signed an informed consent form provided by the facility which includes an explanation of the repackaging process and which notifies the resident of the immunities from liability provided in this section.

A supplier who furnishes a methamphetamine precursor substance to a person in Minnesota shall, not less than 21 days before delivery of the substance, submit to the Bureau of Criminal Apprehension a report of the transaction that includes the identification information specified in Minnesota Pharmacy Law. a. True b. False

Answer: (a) True, [Minnesota Pharmacy Practice Act Chapter 152, Section 152.0973 Subdivision 1]. Predelivery notice: A supplier who furnishes a precursor substance to a person in this state shall, not less than 21 days before delivery of the substance, submit to the Bureau of Criminal Apprehension a report of the transaction that includes the identification information specified in subdivision 3. Subd. 3.Proper identification. A report submitted by a supplier or purchaser under this section must include: (1). the purchaser's driver's license number or state identification number and residential or mailing address other than a post office box number taken from the purchaser's driver's license or state identification card, if the purchaser is not an authorized agent; (2). the motor vehicle license number of the motor vehicle operated by the purchaser at the time of sale, if the purchaser is not an authorized agent; (3). a complete description of how the precursor substance will be used, if the purchaser is not an authorized agent; (4). a letter of authorization from the business for which the precursor substance is being furnished, including the state tax identification number and address of the business, a full description of how the precursor substance is to be used, and the signature of the authorized agent for the purchaser; (5). the signature of the supplier as a witness to the signature and identification of the purchaser; (6). the type and quantity of the precursor substance; (7). the method of delivery used; and (8). the complete name and address of the supplier. All records file under this section shall be kept for at least 5 years.

The recent Federal law prohibits the use of PRESCRIPTION opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years. a. True b. False

Answer: (a) True, [https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592109.htm]. In January 2018, Food and Drug Administration (FDA) announced that the agency is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. In addition, labeling for the medications will be updated with additional safety information for adult use. This update will include an expanded Boxed Warning notifying consumer about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.

A practitioner's AUTHORIZED AGENT may transmit a valid Schedule II controlled substance prescription to a pharmacy via facsimile for patients enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII. a. True b. False

Answer: (a) True, [https://www.federalregister.gov/articles/2010/10/06/2010-25136/role-of-authorized-agents-in-communicating-controlled-substance-prescriptions-to-pharmacies#h-8]. Because Schedule II controlled substances have the highest potential for abuse and the greatest likelihood of dependence among the pharmaceutical controlled substances (those in Schedules II-V), the CSA controls on Schedule II drugs are the most restrictive. The CSA requires that a Schedule II controlled substance be dispensed by a pharmacy only pursuant to a written prescription, except in emergency situations, and prohibits Schedule II prescriptions from being refilled. 21 U.S.C. 829(a). Thus, in most cases, a pharmacist must receive the original, manually signed paper prescription or an electronic prescription prior to dispensing a Schedule II controlled substance. 21 CFR 1306.11(a). DEA regulations specify two exceptions whereby a Schedule II controlled substance prescription sent by facsimile may serve as the original written prescription. A practitioner or a practitioner's AUTHORIZED AGENT may transmit a valid Schedule II controlled substance prescription to a pharmacy via facsimile for: (1). Patients enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or hospice programs which are licensed by the State (21 CFR 1306.11(g)); and (2). residents of LTCFs (21 CFR 1306.11(f)). The facsimile serves as the original written prescription and must be maintained by the pharmacy as such. An authorized agent of the prescribing practitioner may TRANSMIT the practitioner-signed prescription by facsimile on behalf of the practitioner.

The use of a patient's own medication during or after admittance to a hospital should be discouraged as a general or routine practice. a. True b. False

Answer: (a) True. No drugs shall be administered to a patient except those provided through the pharmacy or as provided by written policies and procedures developed by the registered pharmacist-in-charge or, where applicable, the director of pharmaceutical services and approved by the Pharmacy and Therapeutics Committee. Although the use of a patient's own medications may be warranted in certain situations, it should be discouraged as a general or routine practice. If a patient's previously acquired medication is to be used, a written order to this effect shall be signed and dated by the patient's physician. Such medications shall be identified by the pharmacist as to contents and dispensing origin. Also, these medications shall be documented as part of the pharmacy's patient profile record system.

According to Minnesota State Pharmacy Law, the prescription record should be kept on file for: a. Two years from the date of dispensing. b. Five years from the date of dispensing. c. Three years from the date of dispensing. d. A year from the date of dispensing.

Answer: (a) Two years from the date of dispensing, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.211]. All prescriptions dispensed shall be kept on file at the location in which such dispensing occurred for a period of at least two years.

The compounding of Cisplatin shall be performed under: a. Vertical laminar flow b. Horizontal laminar flow

Answer: (a) Vertical laminar flow, [Minnesota Administrative Rules Chapter 6800 Sec.6800.8005]. A. Cytotoxic drugs shall be compounded in a vertical flow, Class II, biological safety cabinet. B. Protective apparel, such as disposable masks, gloves, and gowns with tight cuffs, shall be worn by personnel compounding cytotoxic drugs. C. Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile products. D. Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements. E. Written procedures for handling both major and minor spills of cytotoxic agents must be developed and must be included in the policy and procedures manual. F. Prepared doses of cytotoxic drugs must be dispensed and shipped in a manner that will minimize the risk of accidental rupture of the primary container.

A Home-Care Pharmacy compounds a stock solution that contains 30 grams of Codeine per 100 ml of distilled water. Does Home-Care Pharmacy require to obtain a manufacturing license under the Controlled Substances Act (CSA)? a. Yes b. No

Answer: (a) Yes, [21CFR 1301.13(e)(1)(iv)]. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II-V in a proportion not exceeding 20 % of the complete solution, compound or mixture without obtaining a manufacturer license. In the above question 30 grams of codeine are present in the final mixture (100 cc), which suggests a narcotic controlled substance proportion 30% of the compounded product. Therefore, Home-Care Pharmacy must obtain a manufacturing license before compounding the product.

FEDERAL LAW: A pharmacist adds 100mg pure codeine powder to 4 ounces of distilled water. Can the resultant mixture be sold over the counter by the pharmacist? a. Yes b. No

Answer: (a) Yes, [21CFR1308.15(c)(1) and [21CFR1306.26(a)-to-(e)]. Under section 1306.26(b), a pharmacist can sell no more than 120 milliliters or 4 ounces of solution containing any other controlled substance (e.g. codeine) to the same purchaser in any given 48-hour period without a prescription.

A drug manufacturer in New York ship its drugs to wholesale distributor located in Kentucky which then sale manufacturer's drugs to residents of Minnesota. Does the manufacturer in New York require to obtain the manufacturer's license from Minnesota? a. Yes b. No

Answer: (a) Yes, [Minnesota Administrative Rules Chapter 6800 Sec.6800.1400 Subp. 3]. A separate license is required for each separate location involved in wholesale drug distribution within this state and each separate out-of-state location from which drugs are shipped into this state. A manufacturer that does not ship drugs into this state from any location that it directly operates must still obtain a license according to Minnesota Statutes, section 151.25, if it does business with accounts in this state. Doing business in this state includes any sale of a manufacturer's drug to any individual or business in Minnesota.

May a pharmacy located in Minnesota accept returns of and redispense unopened, unused drugs in board-approved unit dose packaging and medical devices from county jails and juvenile correctional facilities?

Answer: (a) Yes, [Minnesota Pharmacy Act Chapter 151.56]. Pharmacies may accept returns of and redispense unopened, unused drugs in board-approved unit dose packaging and medical devices from county jails and juvenile correctional facilities. In order to return unused drugs and medical devices, the county jail or juvenile correctional facility must have a correctional employee trained in the delivery and storage of medications on hand 24 hours a day, seven days a week, and the medication must be stored in a secured locked storage locker.

In ISO class 5, colony-forming unit (cfu) per 1000 liters of air per plate count of viable air sampling is found to be 5. Shall this prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures, and air filtration efficiency within the aseptic compounding location? a. Yes b. No

Answer: (a) Yes. The value of viable microbial sampling of the air in the compounding environment is realized when the data are used to identify and correct an unacceptable situation. Sampling data shall be collected and reviewed on a periodic basis as a means of evaluating the overall control of the compounding environment. If an activity consistently shows elevated levels of microbial growth, competent microbiology personnel shall be consulted. Any cfu count that exceeds its respective action level (see Table below) should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures, and air filtration efficiency within the aseptic compounding location. Recommended Action Levels for Microbial Contamination (cfu per cubic meter [1000 liters] of air per plate) for Viable Air Sampling: Classification Air Sample ISO Class 5 > 1 ISO Class 7 > 10 ISO Class 8 or worse > 100 CFU: Colony Forming Units

A patient brings a new prescription for Alprazolam with 5 eligible refills. The prescription is written on April 1, 2017. The prescription reads: Alprazolam 1 mg: 1 tablet by mouth at bed time x 30 days. Refills: 5 times A patient has requested medication to be partially filled. Below is the list of partially filled transactions: 1. 04/04/2017: 20 tablets 2. 05/05/2017: 40 tablets 3. 05/25/2017: 18 tablets 4. 06/09/2017: 23 tablets 5. 06/21/2017: 5 tablets 6. 08/11/2017: 35 tablets 7. 09/05/2017: 11 tablets 8. 10/11/2017: 36 tablets 9. 10/28/2017: 21 tablets 10. 11/05/2017: 6 tablets Based on above information what shall be the dispensed quantities (legally)? a. 180 tablets b. 152 tablets c. 150 tablets d. Cannot be partially filled

Answer: (b) 152 tablets, [http://www.deadiversion.usdoj.gov/faq/general.htm]. Partial refills of schedules III and IV controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs after six months past the date of issue. In above example, the prescription expires on 10/01/2017 (six months from an issue date of 04/01/2017). Therefore, all partial filling before this date should be considered legal. The second thing the pharmacist has to observe that the total quantity dispensed in all partial fillings shall not exceed the total quantity prescribed. The prescription is written for 180 tablets, 1 tablet by mouth qd x 30 days with additional 5 refills. When adding all the partial filling starting from 04/04/2017 to 09/05/2017, the total quantities that the pharmacist can dispense legally come about 152 tablets.

A unique number the purchaser assigns to track the order must be included on an DEA 222 electronic order for Schedule I and II controlled substances. The unique number shall consist of: a. 10 character long starting with 'NAP'. b. 18XLauren c. 9 character long ending with 'X' d. DEA222-12589525

Answer: (b) 18XLauren, [21CFR1305.21]. (a). To be valid, the purchaser must sign an electronic order for a Schedule I or II controlled substance with a digital signature issued to the purchaser, or the purchaser's agent, by DEA as provided in part 1311 of this chapter. (b). The following data fields must be included on an electronic order for Schedule I and II controlled substances: (1). A unique number the purchaser assigns to track the order. The number must be in the following 9-character format: the last two digits of the year (e.g. 18), X, and six characters as selected by the purchaser (e.g. Lauren). (2). The purchaser's DEA registration number. (3). The name of the supplier. (4). The complete address of the supplier (may be completed by either the purchaser or the supplier). (5). The supplier's DEA registration number (may be completed by either the purchaser or the supplier). (6). The date the order is signed. (7). The name (including strength where appropriate) of the controlled substance product or the National Drug Code (NDC) number (the NDC number may be completed by either the purchaser or the supplier). (8). The quantity in a single package or container. (9). The number of packages or containers of each item ordered. (c). An electronic order may include controlled substances that are not in schedules I and II and non-controlled substances.

What is the maximum day supply of medications issued to residents who are going on leave from a licensed nursing facility at times when the resident's pharmacy is closed or cannot supply the needed medication in a timely manner? a. 1-day b. 3-day c. 14-day d. 21-day

Answer: (b) 3-day, [Minnesota Administrative Rules Chapter 6800 Sec.6800.6500 Subpart 2(H)]. The law may allow not more than a 72-hour supply of discharged medications to be dispensed, in paper envelopes or other more suitable containers for use by a resident temporarily leaving the facility, at times when the resident's pharmacy is closed or cannot supply the needed medication in a timely manner. A container may hold only one medication. A label on the container shall include the date, the resident's name, the facility, the name of the medication, its strength, dose, and time of administration, and the initials of the person preparing the medication and label.

Before a licensed pharmacy changes the location of its business, it shall first submit to the Board of Pharmacy a new application for a license setting forth the changes and shall submit the information and documents required in an initial application for license. The new application and supporting documents shall be submitted at least: a. 30 days before the proposed change in location. b. 60 days before the proposed change in location. c. 90 days before the proposed change in location. d. 120 days before the proposed change in location.

Answer: (b) 60 days before the proposed change in location, [Minnesota Administrative Rules Chapter 6800 Sec.6800.0800]. Before a licensed pharmacy changes the location of its business, it shall first submit to the Board of Pharmacy a new application for a license setting forth the changes and shall submit the information and documents required in an initial application for license. The new application and supporting documents shall be submitted at least 60 days before the proposed change in location. If the Board of Pharmacy approves the application, no additional charge shall be made for the new license. Similarly, no licensed pharmacy in Minnesota shall change its physical dimensions or elements of physical security until it has submitted documents and plans of the proposed changes to the Board of Pharmacy. The documents and plans shall be submitted at least 60 days before the proposed changes. The board shall, within 30 days after receipt of the proposed changes, notify the licensee that the proposed changes either comply or do not comply. Failure of the board to respond in writing within 30 days shall be considered to be approval of the proposed changes.

An emergency oral prescription for Schedule II controlled drugs must be mailed to dispensing pharmacy by an authorized prescriber within: a. 48 hours after an oral authorization. b. 7 days after an oral authorization. c. 10 days after an oral authorization. d. 72 hours after an oral authorization.

Answer: (b) 7 days after an oral authorization, [Minnesota Administrative Rules Chapter 6800 Sec.6800.6200 Subpart 3(A),(B),(C), Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.11 Subdivision 1a and 21CFR1306.11(d)(1-to-4)]. An emergency oral prescription for Schedule II controlled drugs must be written to reduce and mailed to dispensing pharmacy by an authorized prescriber within 7 days after an oral authorization, (Note: section 152.11 Subdivision 1a of Minnesota Pharmacy Law indicates the dispensing of schedule II controlled substance in emergency situation should be based on Federal Regulation)

Which of the following helps customers to ensure the prescription drugs they order from online pharmacies are safe and legitimate? a. The web site shall have verified NABP X-NPI number. b. A .pharmacy domain is part of a website's address. c. The presence of DEA "Internet Verified Seal" on the home page of website. d. All of the above.

Answer: (b) A .pharmacy domain is part of a website's address, [www.safe.pharmacy/apply]. With only 4% of websites selling prescription drugs online following United States pharmacy laws and practice standards, consumers seeking medications online are faced with the daunting task of finding a safe site. To assist consumers and those legitimate pharmacies with an online presence, NABP has streamlined its website verification programs. As of September 1, 2017, NABP is only offering the .Pharmacy Verified Websites Program and the Verified Internet Pharmacy Practice Sites® (VIPPS®) program, providing an easy choice for safety-minded consumers and pharmacies alike. The .Pharmacy Program, which was launched in 2014, enables qualified pharmacies and pharmacy-related businesses to register a web address with the .pharmacy domain. A .pharmacy domain (pronounced "dot pharmacy") is part of a website's address like ".com" or ".biz": www.safe.pharmacy. It enables people to identify an online pharmacy or pharmacy-related website as safe and legitimate. Since .pharmacy is a verified domain, websites are evaluated against a set of safety standards before an applicant is approved to register the domain. In addition to showing patients that they operate a safe website, the .pharmacy domain allows pharmacies and related entities to advertise online through Google, Bing, and Yahoo! The .Pharmacy Program replaces the e-Advertiser Approval and Veterinary VIPPS® programs for those entities that are not eligible to apply for VIPPS but want to advertise with the search engines.

If we crush and add 10 tablets of Tylenol No. 3 to 100 ml distilled water. The resultant mixture should be classified as a: a. Schedule II controlled drug b. Schedule III controlled drug c. Schedule IV controlled drug d. Schedule V controlled drug

Answer: (b) A schedule III-controlled drug, [21CFR1308.13(e)(1)(ii)]. According to CSA any material, compound, mixture, or preparation containing not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts shall be classified under Schedule III controlled substances. Each Tylenol No. 3 tablet contains 30mg of Codeine. The resultant mixture should contain 300mg of Codeine per 100ml of solution. Therefore it should be classified as a Schedule III controlled substance.

Which of the following controlled substances in oral dosage forms shall be excluded from the emergency kit? a. Alprazolam b. Amphetamine c. Codeine d. Oxycodone

Answer: (b) Amphetamine, [Minnesota Administrative Rules Chapter 6800 Sec.6800.6700 Subpart 4]. Controlled substance stimulants in oral dosage forms may not be included in emergency kits. **Conflict information Minnesota Administrative Rules Chapter 6800 Sec.6800.8007 Subpart 4 (C) (4)** (4). limited to drugs that are not controlled substances.

In which of the following areas is the primary engineering control (PEC) physically located? a. Ante Area b. Buffer Area c. Critical Area d. Clean Room area

Answer: (b) Buffer Area. Buffer Area: An area where the primary engineering control (PEC) is physically located. Activities that occur in this area include the preparation and staging of components and supplies used when compounding CSPs

Gloves, gowns or other materials that have chemotherapy drugs spilled on them shall be classified under: a. Trace chemotherapy wastes b. Bulk chemotherapy wastes c. Load chemotherapy wastes d. No-Load chemotherapy wastes

Answer: (b) Bulk chemotherapy wastes. Chemotherapy wastes can be classified into two categories: 1. Trace chemotherapy wastes 2. Bulk chemotherapy wastes 1. Trace chemotherapy wastes fall into two categories: A. Items contaminated with residual amounts of chemotherapy drugs, such as empty drug bottles, drug dispensing devices or IV bags and tubing. B. Gloves, gowns, masks, goggles and other disposable items used when administering chemotherapy drugs if chemotherapy drugs have not spilled, leaked or dripped on them. 2. Bulk chemotherapy waste is any waste contaminated with more than residual amounts of chemotherapy drugs. Examples include: A. Drug dispensing devices or IV bags that are not completely empty; B. Gloves, gowns or other materials that have chemotherapy drugs spilled on them; and spill cleanup materials.

The partial supply of which of the following should be done within 72 hours from its initial dispensing if the pharmacist is unable to supply the full quantity requested in a written prescription: a. Xanax b. Adderall c. Cylert d. Sonata

Answer: (b) Dextroamphetamine (Adderall), [21CFR1306.13(a),(b)]. The partial filling of a prescription for a controlled substance listed in Schedule II is permissible if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription, written record of the emergency oral prescription, or in the electronic prescription record. The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription. CARA 2016 amended the CSA to allow for the partial dispensing of a schedule II prescription if not prohibited by state law, requested by the patient or prescriber and the total quantity dispensed in partial fillings does not exceed the total quantity prescribed. 21 U.S.C. § 829(f)(1). The amended CSA prohibits further partial dispensing later than 30 days after the prescription is written and no later than 72 hours in emergency situations. 21 U.S.C. § 829(f)(2).

A written prescription that contains the photocopy of the prescriber's signature is considered a valid prescription. a. True b. False

Answer: (b) False, [21 CFR Section 1306.15(d)]. Carbon or duplicate written prescriptions are not valid prescriptions. A written prescription must bear the original signature of the prescriber, not a copy or photo copy or stamp of the signature of the prescriber

An individual practitioner who is an agent or employee of another practitioner registered to dispense controlled substances may, when acting in the normal course of business or employment, prescribe, administer or dispense controlled substances if and to the extent that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she practices. a. True b. False

Answer: (b) False, [21CFR Section 1301.22(b)]. An individual practitioner who is an agent or employee of another practitioner (other than a mid-level practitioner) registered to dispense controlled substances may, when acting in the normal course of business or employment, ADMINISTER or DISPENSE (other than by issuance of prescription-NO PRESCRIBING) controlled substances if and to the extent that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she practices, under the registration of the employer or principal practitioner in lieu of being registered him/herself.

A pharmacy that has been issued a registration under Title 21 CFR Section 1301.13 shall request the NABP to modify its registration to authorize the pharmacy to dispense controlled substances by means of the Internet as an online pharmacy. a. True b. False

Answer: (b) False, [21CFR1301.19(a)]. Administrator means the Administrator of the Drug Enforcement Administration. The Administrator has been delegated authority under the Act by the Attorney General (28 CFR 0.100). (a). A pharmacy that has been issued a registration under §1301.13 may request that the Administrator (Not NABP) modify its registration to authorize the pharmacy to dispense controlled substances by means of the Internet as an online pharmacy. The Administrator may deny an application for a modification of registration if the Administrator determines that the issuance of a modification would be inconsistent with the public interest. In determining the public interest, the Administrator will consider the factors listed in section 303(f) of the Act (21 U.S.C. 823(f)). (b). Each online pharmacy shall comply with the requirements of State law concerning licensure of pharmacies in each State from which it, and in each State to which it, delivers, distributes, or dispenses, or offers to deliver, distribute, or dispense controlled substances by means of the Internet. (c). Application for a modified registration authorizing the dispensing of controlled substances by means of the Internet will be made by an online application process as specified in §1301.13 of this part. Subsequent online pharmacy registration renewals will be accomplished by an online process. (d). A pharmacy that seeks to discontinue its modification of registration authorizing it to dispense controlled substances by means of the Internet as an online pharmacy (but continue its business activity as a non-online pharmacy) shall so notify the Administrator by requesting to modify its registration to reflect the appropriate business activity.

Under CSA, a prescription written for Alprazolam for "office stock" should only be filled by the pharmacist-in-charge. a. True b. False

Answer: (b) False, [21CFR1306.04(b)]. A prescription may not be issued in order for an individual practitioner to obtain a supply of controlled substances for the purpose of general dispensing to his/her patients, Therefore, a prescription written for office stock or "medical bag" use is not valid.

Under the new Federal Pharmacy Law section 21CFR1306.05, the prescribing practitioner may delegate his or her signature authority to a physician's assistant. a. True b. False

Answer: (b) False, [21CFR1306.05(a)(f), 21CFR 1306.05(d), 21CFR 1306.05(e), 21 CFR 1311.140 and https://www.federalregister.gov/]. Controlled substance prescriptions are orders for medication to be dispensed to an ultimate user and are required to contain specific information including: Patient name, address, drug name and strength, quantity prescribed, directions for use, and the name, address and DEA number of the issuing practitioner, 21 CFR 1306.05(a). All prescriptions for controlled substances must be dated as of, and signed on, the day when issued. Paper prescriptions must be manually signed by the issuing practitioner in the same manner that the practitioner would sign a check or other legal document (21 CFR 1306.05(d)); electronic prescriptions for controlled substances must be signed in accordance with DEA regulations (21 CFR 1306.05(e), 21 CFR 1311.140). The regulations provide that prescription may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations.", 21 CFR 1306.05(f). Accordingly, an authorized agent may prepare a controlled substance prescription only based on the instructions of the prescribing practitioner as to the required elements of a valid prescription and then provide the prescription to the practitioner to review. The authorized agent does not have the authority to make medical determinations. The practitioner must personally sign the prescription, whether manually or electronically. The prescribing practitioner CANNOT delegate his or her signature authority.

Any controlled drug prescription, including prescriptions for Schedule II drugs that are sent to a pharmacy via e-prescribing, may be forwarded to any other pharmacy if done through the use of an e-prescribing system. The Schedule II prescription could only be forwarded using e-prescribing to another pharmacy that shared the same computer system. a. True b. False

Answer: (b) False, [Electronic Prescriptions for Controlled Substances, https://www.deadiversion.usdoj.gov/ecomm/e_rx/]. Any controlled drug prescription, including prescriptions for Schedule II drugs that are sent to a pharmacy via e-prescribing, may be forwarded to any other pharmacy if done through the use of an e-prescribing system. Until now, the understanding has been that a Schedule II prescription could only be forwarded using e-prescribing to another pharmacy that shared the same computer system. That is no longer the case. According to Loren Miller, DEA's associate section chief of the Liaison and Policy Section of the agency's Diversion Control Division, "As posted in the preambles of the [notice of proposed rulemaking] and the [interim final rule], an unfilled original [electronic prescription for controlled substances] can be forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy, and this includes Schedule II controlled substances."

According to Minnesota State Pharmacy Law, each pharmacy shall notify the Board of Pharmacy within 72 hours of the termination of the services of the pharmacist-in-charge. a. True b. False

Answer: (b) False, [Minnesota Administrative Rules Chapter 6800 Sec.6800.2400 Subpart 4]. According to Minnesota State Pharmacy Law, each pharmacy shall notify the Board of Pharmacy immediately (NOT within 72 hours) upon knowledge of the termination of the services of the pharmacist-in-charge; further, the pharmacy shall immediately designate a successor pharmacist-in-charge and immediately notify the Board of Pharmacy of such designation. The Board of Pharmacy, upon receiving such notice, shall furnish the successor pharmacist-in-charge such form or forms, as it may from time to time prescribe which form or forms must be completed by the successor pharmacist-in-charge and filed with the Board of Pharmacy within ten days after receipt thereof. The successor pharmacist-in-charge shall submit, on the approved form, an acknowledgment of an awareness and understanding of any variances that the pharmacy has been granted according to part 6800.9900. The successor pharmacist-in-charge shall be responsible for ensuring that any conditions imposed by the board on granted variances continue to be met.

A pharmacist or pharmacist-intern shall notify the Board of Pharmacy within 10 days of any change in location of employment or any change of residence address. a. True b. False

Answer: (b) False, [Minnesota Administrative Rules Chapter 6800 Sec.6800.2500]. A pharmacist or pharmacist-intern shall notify the Board of Pharmacy immediately (not within 10 days) of any change in location of employment or any change of residence address.

A pharmacy technician must report any changes in name, residence, or place of employment to the board within 15 days of the change. a. True b. False

Answer: (b) False, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3850 SubPart 1d]. A pharmacy technician must report any changes in name, residence, or place of employment to the board within 10 days of the change.

The partial filling of Morphine sulfate for terminally ill patients must be done within 72 hours from the initial filling. a. True b. False

Answer: (b) False, [Minnesota Administrative Rules Chapter 6800 Sec.6800.4300 Subpart 1-to-4 and 21CFR1306.13(a)]. Prescriptions for schedule II controlled substances written for patients in long-term care facilities and terminally ill patients may be dispensed in partial quantities, including individual dosage units. For each partial dispensing, the dispensing pharmacist shall record on the back of the prescription, or on another appropriate record uniformly maintained and readily retrievable, the date of the partial dispensing, the quantity dispensed, the remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." The total quantity of schedule II controlled substances dispensed in all partial dispensings must not exceed the total quantity prescribed. Schedule II prescriptions for patients in a long-term care facility and terminally ill patients shall be valid for a period not to exceed 60 days from the issue date unless terminated sooner by the discontinuance of medication.

Any pharmacy detecting the theft or significant loss of any controlled substance drug must report the loss, in writing, to the Board and to the Drug Enforcement Administration within 14 days of such occurance. a. True b. False

Answer: (b) False, [Minnesota Administrative Rules Chapter 6800 Sec.6800.4800]. Any pharmacy, drug wholesaler, drug manufacturer, or controlled substance researcher detecting the theft or significant loss of any controlled substance drug, where the loss is attributable to other than inadvertent error, must report the loss, in writing, to the board and to the Drug Enforcement Administration IMMEDIATELY (Not within 14 days). The report must include a description of how the loss occurred, if known, the date the loss occurred, if known, the steps being taken to prevent future losses, and an inventory of the missing drugs.

Candidates for licensure shall submit evidence that they have successfully completed not less than 1,500 hours of internship under the direction and supervision of a preceptor. a. True b. False

Answer: (b) False, [Minnesota Administrative Rules Chapter 6800 Sec.6800.5400 SubPart 6]. Candidates for licensure shall submit evidence that they have successfully completed not less than 1,600 hours of internship under the direction and supervision of a preceptor. Credit for internship shall be granted only to registered interns who have completed the third year of the five-year or six-year pharmacy curriculum, provided, however, that: A. no more than 400 hours of concurrent time internship will be granted to an intern; and B. 800 hours of internship credit may be acquired through experiential education program experiences that do not have as their focus traditional compounding, dispensing, and related patient counseling activities. The remaining 800 hours of the 1,600 hour total requirement must focus on traditional compounding, dispensing, and related patient counseling activities.

Under Minnesota State Pharmacy Law, no more than one intern shall be trained by a preceptor at one time. a. True b. False

Answer: (b) False, [Minnesota Administrative Rules Chapter 6800 Sec.6800.5400 Subpart 4]. A licensed pharmacist shall not be the preceptor for more than two interns at one time.

If the prescription has been certified by a pharmacist at a licensed central service pharmacy, an additional certification is still required by the receiving pharmacy that dispenses, mails, or ships the completed prescription to a patient. a. True b. False

Answer: (b) False, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.215]. A pharmacist must certify a prescription, in compliance with Minnesota Board of Pharmacy rules, before the prescription is dispensed, delivered, mailed, or shipped to a patient or a patient's caregiver. However, if the prescription has been certified by a pharmacist at a licensed central service pharmacy, in compliance with Minnesota Board of Pharmacy rules, an additional certification is not required at the pharmacy that dispenses, mails, or ships the completed prescription to the patient.

Under Minnesota State Pharmacy Law, a licensed doctor of veterinary medicine, in good faith, and in the course of professional practice only, may prescribe, administer, and dispense a controlled substance included in Schedules II through V for use by a human being. a. True b. False

Answer: (b) False, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.37 Subdivision 3]. Under Minnesota State Pharmacy Law, a licensed doctor of veterinary medicine, in good faith, and in the course of professional practice only, CANNOT prescribe, administer, and dispense a controlled substance included in Schedules II through V for use by a human being.

Under Minnesota Pharmacy Law, resales of donated cancer drugs or supplies are permitted. a. True b. False

Answer: (b) False, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.55 Subdivision 9]. According to Minnesota Pharmacy Law, resales of donated cancer drugs or supplies are NOT permitted.

According to Minnesota Pharmacy Law, pediatric products containing pseudoephedrine or any other methamphetamine precursor drugs primarily intended for administration to children under 12 years of age shall be classified as Schedule V controlled substances. a. True b. False

Answer: (b) False, [Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.02 Subdivision 6(k)]. The following methamphetamine precursor drugs are exempt from schedule V controlled substances requirement: (1). pediatric products labeled pursuant to federal regulation primarily intended for administration to children under 12 years of age according to label instructions; (2). methamphetamine precursor drugs that are certified by the Board of Pharmacy as being manufactured in a manner that prevents the drug from being used to manufacture methamphetamine; (3). methamphetamine precursor drugs in gel capsule or liquid form; or (4). compounds, mixtures, or preparations in powder form where pseudoephedrine constitutes less than 1% of its total weight and is not its sole active ingredient.

No person may acquire through over-the-counter sales more than 12 grams of methamphetamine precursor drugs within a 30-day period. a. True b. False

Answer: (b) False, [Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.02 Subdivision 6,(f)]. No person may acquire through over-the-counter sales more than 6 grams (NOT 12) of methamphetamine precursor drugs within a 30-day period. No person may sell in an over-the-counter sale a methamphetamine precursor drug to a person under the age of 18 years.

Repackaged unused drugs that are returned by a Long-Term Care Facility to a pharmacy can be redispensed. a. True b. False

Answer: (b) False, [Minnesota Pharmacy Act Chapter 151.415 Subdivision 6]. Repackaged unused drugs that are returned by a Long-Term Care Facility to a pharmacy shall NOT be redispensed.

A written prescription that contains the photocopy of the prescriber's signature is considered a valid prescription. a. True b. False

Answer: (b) False, [Minnesota Pharmacy Practice Act 152.11 Subdivision 1a]. No person may dispense a controlled substance included in Schedule II without a prescription issued by a doctor of medicine, a doctor of osteopathy licensed to practice medicine, a doctor of dental surgery, a doctor of dental medicine, a doctor of podiatry, or a doctor of veterinary medicine, lawfully licensed to prescribe in this state or by a practitioner licensed to prescribe controlled substances by the state in which the prescription is issued, and having a current federal Drug Enforcement Administration registration number. The prescription must either be printed or written in ink and contain the HANDWRITTEN SIGNATURE of the prescriber or be transmitted electronically or by facsimile. Carbon or duplicate written prescriptions are not valid prescriptions. A written prescription must bear the original signature of the prescriber, not a copy or photo copy or stamp of the signature of the prescriber.

A pharmacist must substitute to a generic drug for prescribed brand name even if the substitution makes the transaction ineligible for third-party reimbursement. a. True b. False

Answer: (b) False, [Minnesota Pharmacy Practice Act 152.21 Subpart 5]. A pharmacist shall not require to substitute to a generic drug for prescribed brand name if the substitution makes the transaction ineligible for third-party reimbursement.

According to DEA, on-hold unfilled controlled substance prescriptions cannot be transferred to another pharmacy. a. True b. False

Answer: (b) False, [https://www.deadiversion.usdoj.gov/ecomm/e_rx/]. There has been some confusion regarding the transfer or forwarding of a prescription that has been placed "on hold." The term "on hold" refers to the situation when a pharmacy receives a new prescription and does not immediately fill it. The new prescription is normally placed in a "hold" file or entered into the pharmacy's computer system. The prescription is not filled by the pharmacy until a later date requested by the patient or mandated by the prescriber. Some pharmacists believe that these on-hold prescriptions cannot be transferred to another pharmacy because the transfer rules only apply to refills. Drug Enforcement Administration (DEA) allows for an unfilled original electronic prescription for controlled substances (EPCS) to be forwarded from one retail pharmacy to another, including Schedule II controlled substances (CS) and therefore on-hold unfilled controlled substance prescriptions CAN be transferred to another pharmacy. DEA permits the transfer of original prescription information for a prescription refill in Schedules III, IV, and V on a one-time basis. The exception to this limit requires both pharmacies to share the same database and the transfer must be processed in real time.

Emergency oral communication of a valid Schedule II controlled substance prescription May BE delegated to an authorized agent. a. True b. False

Answer: (b) False, [https://www.federalregister.gov/ 21 CFR 1306.11(d)]. The CSA contains an exception that allows a practitioner to issue oral prescriptions for Schedule II controlled substances in an emergency. An emergency for this purpose is defined by the Food and Drug Administration in 21 CFR 290.10. DEA regulations limit such an emergency oral prescription to the quantity necessary to treat the patient during the emergency period and require that it be followed up within 7 days by a practitioner-signed, written prescription to the dispensing pharmacy. Moreover, oral emergency prescriptions must immediately be reduced to writing by the pharmacist and must contain all the information ordinarily required in a prescription, except for the signature of the prescribing individual practitioner. If the prescribing individual practitioner is not known to the pharmacist, the pharmacist must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a call back to the prescribing individual practitioner and/or other good faith efforts to ensure the practitioner's identity. Because the more specific requirement that the emergency Schedule II oral authorization must be from a registered individual practitioner supersedes the general rule that an employee or agent of the individual practitioner may communicate prescriptions to a pharmacist, the prescribing individual practitioner must PERSONALLY communicate the emergency oral prescription to the pharmacist. An agent may not call in an oral prescription for a Schedule II controlled substance on behalf of a practitioner even in an emergency circumstance.

Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs shall be used within 6 hours if opened in worse than ISO Class 5 air quality. a. True b. False

Answer: (b) False. 1. Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs shall be used within 1 hour if opened in worse than ISO Class 5 air quality and any remaining contents must be discarded. 2. Single dose vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture. 3. Opened single-dose ampules shall not be stored for any time period. 4. Multiple-dose containers (e.g., vials) are formulated for removal of portions on multiple occasions because they usually contain antimicrobial preservatives. 5. The BUD after initially entering or opening (e.g., needle-punctured) multiple-dose containers is 28 days unless otherwise specified by the manufacturer.

Who may appoint the members of the Minnesota State Pharmacy Board? a. Director of Pharmacy Board b. Governor c. Drug inspector of the state d. Healthcare administrator of the state

Answer: (b) Governor, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.02 and 151.03 and 151.071 Subd 3(h)]. The Minnesota State Board of Pharmacy shall consist of three public members and six pharmacists actively engaged in the practice of pharmacy in the state. Each of said pharmacists should have at least five consecutive years of practical experience as a pharmacist immediately preceding appointment. Members of the board shall be appointed by the governor. An individual licensed or registered by the board shall maintain a current name and home address with the board and shall notify the board in writing within 30 days of any change in name or home address.

Which of the following acts emphasizes the security and safety of health related information? a. FTC b. HIPAA c. OBRA d. FDA Modernization Act

Answer: (b) HIPAA is known as the Health Insurance Portability and Accountability Act, [Public Law 104-191]. It emphasizes the security and safety of health-related information. It was issued in 1996. The major objectives of the HIPAA are: 1. To assure health insurance portability. This will help a person who has preexisting health conditions and wants to change jobs. Before the HIPPA, a person would think twice before changing jobs, if they had preexisting health conditions, because of insurance problems. 2. To prevent or reduce healthcare related fraud and abuse. 3. To ensure the safety and security of each patient's health related information. This will help to keep a patient's condition confidential. 4. To enforce the standard for health.

Which of the following statements is/are TRUE ABOUT the DEA registration renewal process? I. If a renewal application is submitted in a timely manner prior to expiration, the registrant may continue operations, authorized by the registration, beyond the expiration date until final action is taken on the application. II. Regardless of whether a registration is reinstated within the calendar month after expiration, federal law prohibits the handling of controlled substances or List 1 chemicals for any period of time under an expired registration. III. DEA allows the reinstatement of an expired registration for two calendar months after the expiration date. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II are true, [ www.deadiversion.usdoj.gov/drugreg/index.html]. As of January 2017, Drug Enforcement Administration (DEA) will no longer send its second renewal notification by mail. Instead, an electronic reminder to renew will be sent to the email address associated with the DEA registration. In addition, DEA will retain its current policy and procedures with respect to renewal and reinstatement of registration. The policy is described below. 1. If a renewal application is submitted in a timely manner prior to expiration, the registrant may continue operations, authorized by the registration, beyond the expiration date until final action is taken on the application. 2. DEA allows the reinstatement of an expired registration for one calendar month after the expiration date. If the registration is not renewed within that calendar month, an application for a new DEA registration will be required. 3. Regardless of whether a registration is reinstated within the calendar month after expiration, federal law prohibits the handling of controlled substances or List 1 chemicals for any period of time under an expired registration.

Which of the following is/are TRUE for a registrant who wants to change his/her address on the controlled substance certificate of registration? I. Any registrant may apply to change his/her name or address, by submitting a letter of request to the Registration Unit, Drug Enforcement Administration. II. The letter shall contain the registrant's name, address, and registration number as printed on the certificate of registration, and the new name or address as well as the signature of the registrant. III. The registration shall pay an appropriate modification fees to the DEA. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II are true, [21CFR Section 1301.51]. Any registrant may apply to modify his/her registration to authorize the handling of additional controlled substances or to change his/her name or address, by submitting a letter of request to the Registration Unit, Drug Enforcement Administration. The letter shall contain the registrant's name, address, and registration number as printed on the certificate of registration, and the substances and/or schedules to be added to his/ her registration or the new name or address and shall be signed in accordance with Sec. 1301.13(j). If the registrant is seeking to handle additional controlled substances listed in Schedule I for the purpose of research or instructional activities, he/she shall attach three copies of a research protocol describing each research project involving the additional substances, or two copies of a statement describing the nature, extent, and duration of such instructional activities, as appropriate. No fee shall be required to be paid for the modification. The request for modification shall be handled in the same manner as an application for registration. If the modification in registration is approved, the Administrator shall issue a new certificate of registration (DEA Form 223) to the registrant, who shall maintain it with the old certificate of registration until expiration.

Each prepackaged container shall bear a label containing the: I. name and strength of drug II. internal control number III. name of the pharmacy a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II are true, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3200 Subpart 2]. Pharmacies may prepackage and label drugs in convenient quantities for subsequent complete labeling and dispensing according to United States Pharmacopeia, chapter 1146. Such drugs shall be prepackaged by or under the direct supervision of a pharmacist. The supervising pharmacist shall cause to be prepared and kept a packaging control record containing the following information: A. date; B. identification of drug: name, dosage form, manufacturer, manufacturer's lot number, strength, and manufacturer's expiration date if any; C. container specification; D. copy of the label; E. initials of the packager; F. initials of the supervising pharmacist; G. quantity per container; and H. internal control number or date. Labeling. Each prepackaged container shall bear a label containing the following information: A. name of drug; B. strength; C. name of the manufacturer or distributor (NOT the pharmacy) of the finished dosage form of the drug; D. a beyond-use date as provided in part 6800.3350, or any earlier date which, in the pharmacist's professional judgment, is preferable; E. internal control number or date; and F. after July 1, 2008, a physical description, including any identification code that may appear on tablets and capsules or a bar code based on the National Drug Code (NDC). Such a description does not need to be placed on individual unit-doses, provided that the pharmacy dispenses the unit-doses in outer packaging that contains a physical description of the drug or the pharmacy dispenses less than a 72-hour supply of the unit-doses.

Which of the following information regarding Schedule II controlled substances perpetual inventory in Minnesota is/are TRUE? I. Each pharmacy located in this state shall maintain a perpetual inventory system for Schedule II controlled substances. II. The system shall be established in a manner that will provide total accountability in all aspects of Schedule II drug distribution. III. The inventory shall be reconciled with the actual inventory weekly and the reconciliations shall be documented. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II are true, [Minnesota Administrative Rules Chapter 6800 Sec.6800.4600]. Each pharmacy located in this state shall maintain a perpetual inventory system for Schedule II controlled substances. The system shall be established in a manner that will provide total accountability in all aspects of Schedule II drug distribution. The inventory shall be reconciled with the actual inventory monthly (not weekly) and the reconciliations shall be documented. Reconciliation documentation shall be retained for at least two years. Additionally, A person who engages in research, teaching, or educational projects involving the use, study, or testing of controlled substances shall annually, on or before June 1 of each year, apply for registration by the board. An inventory must be done annually (only by Registration Of Controlled Substance Researchers) to document control of each stocked controlled substance.

Which of the following statements about Pharmacist-Intern is/are TRUE? I. Registration as an intern for purposes of participating in a residency or fellowship program remains in effect until the individual obtains licensure as a pharmacist, for two years, or until the completion of the residency or fellowship program, whichever occurs first. II. Interns completing 400 hours or more of their internship requirement in Minnesota must complete an internship manual, provided by the Board. III. All registered interns shall notify the Board within 10 days upon change of employment or residence address. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II are true, [Minnesota Administrative Rules Chapter 6800 Sec.6800.5300]. Every person shall register with the board before beginning a pharmacy internship in Minnesota. Every person participating in a pharmacy residency or fellowship shall either register as an intern or be licensed as a pharmacist. Registration as an intern for purposes of participating in a residency or fellowship program remains in effect until the individual obtains licensure as a pharmacist, for two years, or until the completion of the residency or fellowship program, whichever occurs first. All registered interns shall notify the Board IMMEDIATELY upon change of employment or residence address. Interns completing 400 hours or more of their internship requirement in Minnesota must complete an internship manual, provided by the board, before the board will recognize the completed hours as acceptable for use in meeting the board's internship requirement.

Which of the following statements is/are TRUE to become a certified preceptor? I. Applicants must show that they are participating in the college-based externship program of the University Of Minnesota College Of Pharmacy as an approved preceptor. II. Applicants must show that they are currently in practice at least 20 hours per week as a pharmacist. III. Applicants must show that they have completed at least 4,000 hours of pharmacy practice after licensure, with at least 500 hours of that pharmacy practice after licensure as a pharmacist in Minnesota. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II are true, [Minnesota Administrative Rules Chapter 6800 Sec.6800.5350 Subpart 1 to Subpart 3]. Pharmacists intending to act as preceptors for pharmacist-interns in licensed pharmacies shall first obtain preceptor certificates from the Board. Certificates shall be renewed every other year on the anniversary of their issuance. The Board shall grant certificates or renewals to applicants who fulfill the following requirements. Applicants must show that: _______________________ A. They are participating in the college-based externship program of the University of Minnesota College of Pharmacy as an approved preceptor; or B. They have completed at least 4,000 hours of pharmacy practice after licensure, with at least 2,000 hours (NOT 500 hours) of that pharmacy practice after licensure as a pharmacist in Minnesota. C. They are currently in practice at least 20 hours per week as a pharmacist; D. They have a history of exemplary practice with respect to compliance with state and federal laws; E. They will provide time on a regular basis, at least three times each month, for the purpose of helping their interns meet the competencies of the internship requirement; and F. For renewal of a certificate only, they have participated in an instructional program specifically for preceptors, provided by or approved by the Board, within the previous 24 months.

Which of the following statements are TRUE about emergency kits under Minnesota State Pharmacy Law? I. The drugs shall be limited to the extent possible to a 72-hour supply of any one emergency drug in either sealed ampules, vials, or prefilled syringes. II. The emergency drug supply shall be stored in a container that is sealed by the pharmacist or the pharmacist's agent with a tamperproof seal that must be broken to gain access to the drugs. III. Drugs used from the kit shall be replaced by submitting a prescription for the used item to the pharmacist within 24 hours, and the supply shall be resealed by the pharmacist or the pharmacist's agent. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II are true, [Minnesota Administrative Rules Chapter 6800 Sec.6800.6700 Subpart 1 to Subpart 5 and 6800.8007]. 1. A pharmacy may provide, upon a written or oral request from the quality assurance and assessment committee, limited supplies of drugs for use in an emergency kit. The drugs shall be limited to the extent possible to a 72-hour supply of any one emergency drug in either sealed ampules, vials, or prefilled syringes. If an emergency drug is not available in parenteral form, a supply in an alternate dosage form may be provided. Notwithstanding these restrictions, if the quality assurance and assessment committee considers it necessary, up to a 72-hour supply of each of a maximum of 15 different oral pharmaceuticals, not counting oral antibiotics, restricted to therapeutic categories related to symptomatic patient distress or emergencies may be stocked. An unlimited number of oral antibiotics may be stocked in 72-hour supplies of each. 2. Drugs in the supply shall be properly labeled, including expiration dates and lot numbers. The emergency drug supply shall be stored in a container that is sealed by the pharmacist or the pharmacist's agent with a tamperproof seal that must be broken to gain access to the drugs, and shall be placed in a locked area. 3. The pharmacist shall be notified by the health care facility when drugs from the emergency kit have been used or when the seal has been broken. 4. Drugs used from the kit shall be replaced by submitting a prescription for the used item to the pharmacist within 72 hours (NOT 24 hours), and the supply shall be resealed by the pharmacist or the pharmacist's agent. 5. The pharmacist shall see that the contents of the kit are accurately listed on the container and accounted for. The supply shall be checked and inventoried monthly by the pharmacist who is responsible for control of the kit. Minnesota Administrative Rules Chapter 6800 6800.8007: 6. a system whereby the supplying pharmacy inspects the contents of the emergency box at least every 60 days for expiration dates of the medications, the tamperproof seal, and the correctness of the contents list; and documents and retains records of the inspection. 7. limited to drugs that are not controlled substances.

Which of the following information about Plan-B One Step is/are TRUE? I. It is intended to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse. II. With Plan B One-Step, a patient has up to 72 hours to prevent a pregnancy. III. If a patient is 15 or older, Plan B One-Step is available ONLY through a prescription. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II are true. Plan B One-Step is a backup plan that helps prevent pregnancy after birth control failure. The sooner a patient takes an emergency contraception, the better it works. Plan B One-Step requires just one pill. Other emergency contraception requires two pills, 12 hours apart. With Plan B One-Step, a patient has up to 72 hours (3 days) to prevent a pregnancy. It is not the abortion pill and it isn't a substitute for routine birth control. Plan B is available to all Over-The-Counter without the prescription or presenting an id. A patient is required to take a single pill, as soon as possible within 72 hours, after an unprotected intercourse or a contraceptive failure.

RX-Care Pharmacy (Retail Pharmacy) has a contract with Correct Prescription Pharmacy (Central Fill Pharmacy) to fill prescriptions for RX Care Pharmacy. Which of the following shall be required on the dispensing container of Alprazolam? I. Name and address of RX-Care Pharmacy. II. A DEA registration number of Correct Prescription Pharmacy. III. Name and address of Correct Prescription Pharmacy. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [21CFR1306.14(a),(b)]. (a). The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label showing date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in such prescription or required by law. (b). If the prescription is filled at a central fill pharmacy, the central fill pharmacy shall affix to the package a label showing the retail pharmacy name and address and a unique identifier, (i.e. the central fill pharmacy's DEA registration number) indicating that the prescription was filled at the central fill pharmacy, in addition to the information required under paragraph (a) of this section.

New prescriptions transmitted to a pharmacy's answering machine or an electronic voice recording device may be retrieved by: I. a licensed pharmacist II. a registered pharmacist-intern III. a certified technician a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3000 SubPart 4]. Only a practitioner or a practitioner's agent may transmit a prescription to a pharmacy's answering machine or electronic voice recording device. Prescriptions transmitted to a pharmacy's answering machine or an electronic voice recording device shall only be retrieved by a licensed pharmacist or registered pharmacist-intern working under the immediate and direct supervision of a pharmacist. A technician may not retrieve a prescription from these devices, except in the case where the practitioner or authorized agent of the practitioner is approving additional refills of a prescription previously dispensed from the pharmacy and no other changes are made to the prescription. Personnel used for clerical duties according to part 6800.3850, subpart 7, may not retrieve any prescription information from these devices. Prescriptions retrieved from these devices are considered verbal prescription drug orders that must be reduced to writing.

A pharmacy may perform or outsource centralized prescription drug order filling or centralized prescription drug order processing services provided: I. the parties have the same owner or have a written contract outlining the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of said contract in compliance with federal and state laws and regulations. II. the parties share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to fill or refill a prescription drug order. III. the parties provide the board with a copy of the policy and procedures manual at least 14 days before centralized prescription drug order processing services begin. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [Minnesota Administrative Rules Chapter 6800 Sec.6800.4075 SubPart 2] A pharmacy may perform or outsource centralized prescription drug order filling or centralized prescription drug order processing services provided: 1. The parties have the same owner or have a written contract outlining the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of said contract in compliance with federal and state laws and regulations. 2. The parties share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to fill or refill a prescription drug order. 3. The parties provide the board with a copy of the policy and procedures manual at least 30 days (not 14 days) before centralized prescription drug order processing services begin. 4. A pharmacist or pharmacist intern at the pharmacy that dispenses, delivers, mails, or ships the completed prescription drug order to the patient is responsible for counseling. 5. A pharmacy utilizing a central service pharmacy to provide dispensing functions, drug utilization review, packaging, labeling, delivery of a completed prescription drug order, or other services must notify its patients of that fact.

Who may compound drugs under the Minnesota State Pharmacy Law? I. a licensed pharmacist II. a registered pharmacist-intern III. a certified pharmacy technician a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.15 Subdivision 2]. No proprietor of a pharmacy shall permit the compounding or dispensing of prescriptions except by a pharmacist or by a pharmacist intern under the personal supervision of a pharmacist; or the vending or selling of drugs, medicines, chemicals, or poisons in the proprietor's pharmacy except under the personal supervision of a pharmacist.

Which of the following statements are TRUE about over-the-counter sales of methamphetamine precursor drugs? I. A package shall not contain more than a total of three grams of methamphetamine precursor drugs. II. Each blister pack shall not contain more than two dosage units of methamphetamine precursor drugs. III. All packages of the methamphetamine precursor drugs are displayed behind a checkout counter where the public is not permitted and are offered for sale only by a licensed pharmacist. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.02 Subdivision 6,(d),(e)]. Over-the-counter sales of methamphetamine precursor drugs are limited to: (1). Packages containing not more than a total of three grams of one or more methamphetamine precursor drugs, calculated in terms of ephedrine base or pseudoephedrine base; or (2). For non-liquid products, sales in blister packs, where each blister contains not more than two dosage units, or, if the use of blister packs is not technically feasible, sales in unit dose packets or pouches. A business establishment that sells methamphetamine precursor drugs over-the-counter shall ensure that all packages of the drugs are displayed behind a checkout counter where the public is not permitted and are offered for sale only by a licensed pharmacist, a registered pharmacy technician, or a pharmacy clerk. The establishment shall ensure that the person making the sale requires the buyer: (1). To provide photographic identification showing the buyer's date of birth; and (2b). To sign a written or electronic document detailing the date of the sale, the name of the buyer, and the amount of the drug sold. A document described under clause (2b) must be retained by the establishment for at least three years and must at all reasonable times be open to the inspection of any law enforcement agency.

Which of the following information is/are TRUE about using the prescription monitoring program database? I. The database may be used to identify individuals receiving prescriptions for controlled substances from prescribers who subsequently obtain controlled substances from dispensers in quantities or with a frequency inconsistent with generally recognized standards of use for those controlled substances. II. The database may be used to identify individuals presenting forged or otherwise false or altered prescriptions for controlled substances to dispensers. III. The state or federal occupational licensing board or agency may access the database for the purpose of obtaining information to be used to initiate a disciplinary action against a prescriber. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.126 Subd 5]. (a). The board shall develop and maintain a data of the prescription monitoring program. The board shall maintain data that could identify an individual prescriber or dispenser in encrypted form. The database may be used by permissible users for the identification of: (1). individuals receiving prescriptions for controlled substances from prescribers who subsequently obtain controlled substances from dispensers in quantities or with a frequency inconsistent with generally recognized standards of use for those controlled substances, including standards accepted by national and international pain management associations; (2). individuals presenting forged or otherwise false or altered prescriptions for controlled substances to dispensers. (b). No permissible user identified may access the database for the sole purpose of identifying prescribers of controlled substances for unusual or excessive prescribing patterns without a valid search warrant or court order. (c). No personnel of a state or federal occupational licensing board or agency may access the database for the purpose of obtaining information to be used to initiate a disciplinary action against a prescriber. (d). Data reported shall be made available to permissible users for a 12-month period beginning the day the data was received and ending 12 months from the last day of the month in which the data was received.

In which of the following situations can a pharmacist disclose patient information to a third party without the patient's consent? I. When a pharmacist is performing prospective DUR. II. To assist prescribers in obtaining a comprehensive drug history on a patient. III. When a patient's relative requests such information. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [OBRA 90 and HIPAA]. A pharmacist may disclose patient information to a third party without the patient's consent in the following situations: 1. When a pharmacist is performing prospective DUR. 2. To assist prescribers in obtaining a comprehensive drug history on a patient. 3. To prevent abuse or misuse of any drug or device and the diversion of controlled substances. 4. Provide a medication therapy management program or a quality assurance program.

According to Minnesota State Pharmacy Law, which of the following mid-level practitioners may prescribe and/or dispense a Schedule II controlled substance in the course of their professional practices? I. Physician's assistant II. Nurse practitioner III. Optometrists a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf]. Pursuant to Title 21, Code of Federal Regulations, Section 1300.01(b28), the term mid-level practitioner means an individual practitioner, other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants who are authorized to dispense controlled substances by the state in which they practice. 1. AMB (Ambulance Service) 2. AS (Animal Shelters) 3. DOM (Doctors of Oriental Medicine) 4. ET (Euthanasia Technicians) 5. HMD (Homeopathic Physician) 6. MP (Medical Psychologists) 7. ND (Naturopathic Physician) 8. NP (Nurse Practitioners) 9. NH (Nursing Homes) 10. OD (Optometrists) 11. PA (Physician Assistants) 12. RPH (Registered Pharmacists) For the State of Minnesota, only following mid-level practitioners can either prescribe or administer or both, schedule controlled substances. 1. NP (Nurse Practitioner): Schedule II to V controlled substances (prescribe, administer, dispense and procure). 2. PA (Physician's assistant): Schedule II to V controlled substances (prescribe). 3. OD (Optometrist): Schedule IV and V controlled substances.

Which of the following references is/are useful for the safe handling of antineoplastic and hazardous drugs? I. OSHA Technical Manual—Section VI II. NIOSH Alert III. MSDSs a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only. Hazardous drugs shall be stored, prepared, and handled by appropriately trained personnel under conditions that protect the healthcare workers and other personnel. The following are references for the safe handling of antineoplastic and hazardous drugs in healthcare settings: 1. OSHA Technical Manual—Section VI: Chapter 2, Controlling Occupational Exposure to Hazardous Drugs. 2. NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings (DHHS (NIOSH) Publication No. 2004-165) and updates.

Which of the following information is/are TRUE ABOUT PPE while reconstituting, preparing or admixing hazardous drugs? I. Make sure that gloves are labeled as [ASTM in press] gloves. II. Use double gloving for all activities involving hazardous drugs. III. Use disposable gowns made of polyethylene-non-coated polypropylene. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only. The information about PPE (Personnel Protection Equipment) while reconstituting, preparing or admixing hazardous drugs: 1. Make sure that gloves are labeled as chemotherapy gloves and make sure such information is available on the box [ASTM in press] or from the manufacturer. 2. Consider latex-sensitive workers and remember that a number of glove materials are suitable for protecting workers from antineoplastic drugs. 3. Consider using chemotherapy gloves for hazardous drugs that are not chemotherapy drugs or for which no information is available. 4. Use double gloving for all activities involving hazardous drugs. Make sure that the outer glove extends over the cuff of the gown. 5. Inspect gloves for physical defects before use. 6. Wash hands with soap and water before donning protective gloves and immediately after removal. 7. Change gloves every 30 minutes or when torn, punctured, or contaminated. Discard them immediately in a yellow chemotherapy waste container. 8. Use disposable gowns made of polyethylene-coated polypropylene (which is non-linting and nonabsorbent). These gowns offer better protection than polypropylene gowns against many of the antineoplastic drugs. Make sure gowns have closed fronts, long sleeves, and elastic or knit closed cuffs. 9. Dispose of protective gowns after each use. 10. Use disposable sleeve covers to protect the wrist area and remove the covers after the task is complete.

The proof-of-use sheets must include: I. the patient's name II. the dose administered III. the licensed health care professional's initial a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II, [Minnesota Administrative Rules Chapter 6800 Sec.6800.7520 Subpart 1 (S)]. The proof-of-use sheets must include at least the date and time, the patient's name, the dose administered, and the licensed health care professional's signature (initials are not allowed).

When does a pharmacist license expire? a. January 1 b. March 1 c. August 1 d. December 1

Answer: (b) March 1, [Minnesota Administrative Rules Chapter 6800 Sec.6800.1150]. A pharmacist license expires on March 1 of each year and shall be renewed annually by filing an application for license renewal on or before February 1 of each year, together with a fee of $105. A pharmacist license renewal application received after March 1 is subject to a late filing fee of an amount equal to 50 percent of the renewal fee in addition to the renewal fee. A pharmacist shall post the license or renewal most recently issued by the board or a copy of it in a conspicuous place within the pharmacy in which the pharmacist is practicing. For community pharmacies, this place shall be a place which is readily visible to the public.

JR comes to a pharmacy and requests a transfer of a prescription for Alprazolam from another pharmacy. His patient profile shows that three eligible refills have been left on the prescription. If both pharmacies, transferring and receiving, electronically sharing a real-time, on-line database, how many times may the original prescription be transferred between pharmacies? a. One-time only b. Maximum three times c. As many times as needed until prescription expires d. Cannot be transferred

Answer: (b) Maximum three times, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3120 SubPart 7]. The one-time transfer of the original prescription information for a controlled substance listed in Schedules III, IV, or V, if any authorized refills remain, for the purpose of dispensing is permissible between pharmacies within six (6) months from the date the prescription was issued. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization.

Commingling of returned medication or mixing of lot numbers of returned medication, upon or prior to repackaging, shall result in such medication being deemed: a. Adulterated b. Misbranded

Answer: (b) Misbranded, [Minnesota Administrative Rules Chapter 6800 Sec.6800.2700 SubPart 3]. Commingling of returned medication or mixing of lot numbers of returned medication, upon or prior to repackaging, shall result in such medication being deemed misbranded.

May a retail pharmacist allow to fill a prescription for Oxycontin that is transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment? a. Yes b. No

Answer: (b) No, [21CFR Section 1306.11]. A paper prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original manually signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance.

Section 503B of the Federal Food, Drug, and Cosmetic Act addresses which of the following? a. Traditional Compounders b. Outsourcing Facilities c. Compounding pharmacies d. Compounding nuclear pharmacies

Answer: (b) Outsourcing Facilities. In the United States, the safety and efficacy of drugs are regulated at the federal level under the FDC Act. States have jurisdiction over the practices of medicine and pharmacy. The practice of compounding has traditionally been regulated by individual state pharmacy and other health professional practice laws, and enforced by state boards of pharmacy. In 2012, a multistate meningitis outbreak resulting from the contamination of methylprednisolone acetate, a steroid injection compounded by New England Compounding Center (NECC), caused the death of 64 people and illnesses in more than 800 people. Because of this large outbreak, and ongoing concern about large compounding operations that ship their products broadly to many facilities in anticipation of a need for a medication rather than as a result of an individual prescription, Congress enacted the Drug Quality and Security Act (DQSA). The DQSA has two key components, both of which amend the FDC Act: Title One, The Compounding Quality Act, and Title Two, The Drug Supply Chain Security Act (DQSA). The Compounding Quality Act of DQSA established two sections that established clearly differentiated types of compounding facilities: Section 503A set forth "Traditional Compounders" and Section 503B established "Outsourcing Facilities."

A valid photographic identification is required when a person is purchasing controlled substance listed in: a. Schedule II b. Schedule III c. Schedule IV d. All

Answer: (b) Schedule II or Schedule III only, [Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.11 Subd. 2d]. No person may dispense a controlled substance included in Schedule II or III without requiring the person purchasing the controlled substance, who need not be the person for whom the controlled substance prescription is written, to present valid photographic identification, unless the person purchasing the controlled substance, or if applicable the person for whom the controlled substance prescription is written, is known to the dispenser.

A pharmacist is adding 1000 mg of pure codeine powder to 100 cc of Tylenol with codeine Elixir (120 mg/12 mg/5 cc). The resultant mixture should be classified as: a. Schedule II b. Schedule III c. Schedule IV d. Schedule V

Answer: (b) The compounded mixture should be classified as a Schedule III controlled drug. The amount of Codeine present in the final mixture is 1.24 gms (1000 mg plus 240 mg), [Minnesota Administrative Rules Chapter 6800 Sec.6800.4230(e)(2)]. ** Please note Robitussin A.C is classified schedule III controlled drug under the Minnesota Pharmacy Law ** It has been stated under CSA that if a mixture contains less than 1.8 gms of Codeine per 100 cc, it should be classified as a Schedule III controlled substance.

A pharmacist at Blue-Care Pharmacy receives a call from Red-Care Pharmacy requesting the purchase of 21 capsules of Cephalexin 500mg. Which of the following is TRUE? a. The pharmacist cannot sell the drug. b. The pharmacist can sell the drug as long as a record of the sale is maintained. c. The pharmacist can only sell an unopened, original container of the drug. d. The price charged to the pharmacy must be less than AWC of the drug.

Answer: (b) The pharmacist can sell the drug as long as a record of the sale is maintained.

Robitussin AC syrup is classified as a: a. Schedule II b. Schedule III c. Schedule IV d. Schedule V

Answer: (b) Under Minnesota Pharmacy Law, Robitussin AC syrup is classified as a Schedule III controlled drug, [Minnesota Administrative Rules Chapter 6800 Sec.6800.4230(E)(2) and Sec.6800.4250]. Robitussin AC contains 10mg/100 mg (Codeine/Guaifenesin) per 5 cc of syrup. Therefore 100cc syrup contain 200 mg Codeine. Under the Federal Pharmacy Law, Codeine preparations (Robitussin AC, Phenergan with Codeine) containing no more than 200 mg Codeine per 100 ml or 100 gm are classified as schedule V controlled substances. However, Minnesota State Law does not include any Codeine preparations in Schedule V. Under the Minnesota State Law Schedule III controlled drugs, it has been stated: Not more than 1.80 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts: Cheracol, Elixir, Terpin Hydrate and Codeine, Cosadein, Prunicodeine, Robitussin A.C.

Which of the following shall be included on the dispensing label of every prescription prepared for food-producing species? a. ASD b. WDT c. MDK d. EMC

Answer: (b) WDT or Withdrawal Time. A compounder's responsibility for providing patients with high-quality compounded preparations extends beyond the human species. All portions of this chapter apply to compounded preparations formulated for animal patients. Intended use of any animal patient (e.g., companion, performance, food) shall be determined before compounding for that patient. Because humans can consume animal patients as food, care must be taken to prevent drug residues from entering the human food chain when compounded preparations are used in animal patients. For this reason, all compounders preparing formulations for animals shall possess a functional knowledge of drug regulation and disposition in animal patients. Veterinarians are required by law to provide food producing animal caregivers with an accurate length of time to withhold treated animal tissues (e.g., meat, milk, eggs) from the human food supply. This length of time is referred to as a withdrawal time (WDT) and must also, by law, be included on the dispensing label of every prescription prepared for a food-producing species.

In a hospital, a "proof-of-use" sign-out sheet is used when: a. nurse changes his/her shift. b. controlled substance is procured for a patient. c. patients are going on temporary leave from the hospital. d. to document unutilized left over controlled substance.

Answer: (b) controlled substance is procured for a patient, [Minnesota Administrative Rules Chapter 6800 Subpart 1 Section 7520(S)]. A "proof-of-use" sign-out sheet is used when each dose of controlled substance is procured by the licensed health care professional. No controlled substance may be kept on floor stock unless it is accompanied by the sign-out sheet and each dose is documented by the licensed health care professional at the time the drug is procured from the stock. The proof-of-use sheets must include at least the date and time, the patient's name, the dose administered, and the licensed health care professional's signature.

Good Neighbor Care is a bulk manufacturer of Morphine Sulfate tablet. Its license for manufacturing controlled II drugs shall expire on 12/31/2018. What would be the earliest date the company can apply for re-registration? a. 10/31/2018 b. 07/31/2018 c. 08/31/2018 d. 05/31/2018

Answer: (c) 08/31/2018, [21CFR1301.13(b)]. The bulk manufacturer of controlled substance may apply to be reregistered no more than 120 days before the expiration date of their registration. Any person who is registered (controlled substances) may apply to be reregistered not more than 60 days before the expiration date of his/her registration, except that a bulk manufacturer of Schedule I or II controlled substances or an importer of Schedule I or II controlled substances may apply to be reregistered no more than 120 days before the expiration date of their registration.

In Minnesota, an applicant for licensure by examination shall obtain at least: a. 1,000 hours of internship. b. 1,500 hours of internship. c. 1,600 hours of internship. d. 2,000 hours of internship.

Answer: (c) 1,600 hours of internship, [Minnesota Administrative Rules Chapter 6800 Sec.6800.1250]. In Minnesota, an applicant for licensure by examination shall obtain at least 1,600 hours of internship under the direct supervision of licensed pharmacist (preceptor).

The prescription area of a retail pharmacy in Minnesota must be minimum of: a. 50 square feet b. 150 square feet c. 250 square feet d. 500 square feet

Answer: (c) 250 square feet, [Minnesota Administrative Rules Chapter 6800 Sec.6800.0700]. No person shall be issued a license to conduct a pharmacy located in Minnesota unless the pharmacy: A. contains more than 250 square feet in the dispensing and drug storage area; B. maintains a prescription dispensing counter at least 18 inches deep that provides two linear feet, which must be kept clear and free of all merchandise and other materials not currently in use in the practice of compounding and dispensing, for each pharmacist and each technician working concurrently on compounding and dispensing; this counter shall provide an additional space for computers if they are used in the dispensing process; C. maintains an aisle behind the prescription dispensing counter at least 36 inches wide, extending the full length of the counter, which shall be kept free of obstruction at all times; D. is surrounded by a continuous partition or wall extending from the floor to the permanent ceiling, containing doors capable of being securely locked to prevent entry when the pharmacy is closed;

In which of the following instances, a dispensing of a drug shall be classified as misbranded? a. A tablet falls on a floor dispensed by a pharmacist. b. A spider is found in an original manufacturer container. c. A returned drug is mixed with the drug containing a different lot number. d. A drug is compounded without properly sanitizing the compounding area.

Answer: (c) A returned drug is mixed with the drug containing a different lot number, [Minnesota Pharmacy Practice Act 151.35 and 151.36 and Food, Drugs And Cosmetics 53-1-109]. The choices a, b and d are considered to be adulterated. A drug shall be classified as misbranded if: (a). Its labeling is false or misleading in any particular way. (b). It is in a package form, unless it bears a label containing: (1). the name and place of business of the manufacturer, packer, or distributor; and (2). an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. (c). Any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (d). It is a drug and its container is so made, formed, or filled as to be misleading; or (e). It is an imitation of another drug; or (f). It is offered for sale under the name of another drug. (g). It is dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. (h). It is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive. (i). It was manufactured, prepared, propagated, compounded, or processed in an establishment in any State not duly registered under section 510 of FDCA.

Which of the following is the most appropriate controlled substance registration number for a staff physician who is an employee of a hospital and authorized to prescribe controlled substances under the registration of the hospital? a. BB1244691 b. MB1244691 c. AB1244691-013 d. PB1244691

Answer: (c) AB1244691-013, [21CFR1301.22(c)(5)]. Practitioners (e.g., intern, resident, staff physician, mid-level practitioner) who are agents or employees of a hospital or other institution, may, when acting in the usual course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution in which he or she is employed, in lieu of individual registration, provided that: 1. The dispensing, administering, or prescribing is in the usual course of professional practice. 2. The practitioner is authorized to do so by the state in which they practice. 3. The hospital or institution has verified that the practitioner is permitted to administer, dispense, or prescribe controlled substances within the state. 4. The practitioner acts only within the scope of employment in the hospital or institution. 5. The hospital or institution authorizes the practitioner to administer, dispense, or prescribe under its registration and assigns a specific internal code number for each practitioner. An example of a specific internal code number is depicted below: AB1244691 (Hospital DEA Registration Number)-013 (Physician's Hospital Code Number) Registrant type (first letter of DEA Number): 1. A, B or F: Hospital/Clinic/Practitioner/Teaching Institution/Pharmacy 2. M: Mid-Level Practitioner (APN/CNP/PA/OD/ET,etc) 3. P or R: Manufacturer/Distributor/Researcher/Analytical Lab/Importer/Exporter/Reverse Distributor/Narcotic Treatment Program

All laminar flow hoods must be inspected by a qualified individual for operational efficiency at least every: a. 3 months b. 6 months c. 12 months d. 24 months

Answer: (c) All laminar flow hoods must be inspected by a qualified individual for operational efficiency at least every 12 months. Appropriate records of the inspection must be maintained. Prefilters for the clean air source must be replaced on a regular basis and documented. If the product is assigned an expiration date that exceeds seven days from its compounding date, there must be in-house data or data in the literature to assure the sterility and stability of the product when it is used by the patient.

The containers of all drugs dispensed to inpatients on the basis of chart orders shall be labeled with: I. expiration date. II. date dispensed. III. name of patient. a. I only b. I and II only c. All d. None of the above

Answer: (c) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.7900 SubPart 2]. The containers of all drugs dispensed to inpatients on the basis of chart orders, other than those dispensed pursuant to part 6800.3750, shall be labeled with the following information: A. name of patient; B. name of drug; C. route of administration of drug when necessary for clarification; D. strength of drug; E. auxiliary labels as needed; F. expiration date, if applicable; and G. date dispensed.

In Minnesota, what is the maximum amount of Robitussin A/C that can be dispensed to a given purchaser without a prescription within a 48-hour period? a. 240cc b. 120cc c. Cannot be dispensed d. 480cc

Answer: (c) Cannot be dispensed without a prescription, [Minnesota Administrative Rules Chapter 6800 Sec.6800.4230(e)(2)]. Under Minnesota Pharmacy Law, Codeine containing preparation such as Robitussin A/C shall be classified under Schedule III controlled substances, and cannot be dispensed without a prescription. Please note: Under federal Pharmacy Law, not more than a 4 ounce or 120 ml over-the-counter preparation containing Codeine can be dispensed to a given purchaser within a 48-hour period.

Drugs or medicines which have been subjected to accident, fire, flood, adverse temperatures, or other physical influences which could affect the potency, quality, purity, or efficacy of such drug or medicine should be defined as: a. Adulterated b. Misbranded c. Distressed d. Orphaned

Answer: (c) Distressed drugs, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.39 Subdivision 1]. Distressed drugs are drugs or medicines that have been subjected to accident, fire, flood, adverse temperatures, or other physical influences which could affect the potency, quality, purity, or efficacy of such drug or medicine, or could otherwise cause the drug or medicine to be adulterated or misbranded, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.39 Subdivision 1].

Which of the following requires a tamper-evident packaging? a. Cold EZ lozenges b. Tolnaftate cream c. Prilosec capsules d. Sensodyne fluoride tooth paste

Answer: (c) Each manufacturer and packer who packages an OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident package, if this product is accessible to the public while held for sale. A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. To reduce the likelihood of successful tampering and to increase the likelihood that consumers will discover if a product has been tampered with, the package is required to be distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture). A tamper-evident package may involve an immediate-container and closure system or secondary-container or carton system or any combination of systems intended to provide a visual indication of package integrity. The tamper-evident feature shall be designed to and shall remain intact when handled in a reasonable manner during manufacture, distribution, and retail display.

To renew a registration, a pharmacy technician shall provide the Board with evidence of completion of: I. a pharmacy technician training program offered by a board-approved, accredited vocational/technical institution or college. II. an employer-based pharmacy technician training program that includes a minimum total of 240 hours on a one-year period to include both theoretical and practical instruction. III. a pharmacy technician training program provided by a branch of the United States armed forces or Public Health Service. a. I only b. I and II only c. I or II or III only d. None of the above

Answer: (c) I or II or III only, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3850 SubPart 1h(B)]. Effective January 1, 2014, the board shall not renew the registration of a pharmacy technician unless the individual provides the board with evidence of completion of one of the following: (1). a pharmacy technician training program offered by a board-approved, accredited vocational/technical institution or college; (2). a pharmacy technician training program accredited by a board-approved, national organization that accredits pharmacy technician training programs; (3). a pharmacy technician training program provided by a branch of the United States armed forces or Public Health Service; or (4). an employer-based pharmacy technician training program that includes a minimum total of 240 hours on a one-year period to include both theoretical and practical instruction.

A registrant who discontinues a business or closes a licensed pharmacy in the state shall: I. Notify the Board in writing at least 10 days before a licensed pharmacy closes. II. Surrender his/her current registration. III. Take the legal responsibility to assure the legal transfer or disposal of controlled substances at his operation as a registrant. a. I only b. I and II only c. II and III only d. All

Answer: (c) II and III are true, [Minnesota Administrative Rules Chapter 6800 Sec.6800.1010]. At least 14 days (Not 10 days) before a licensed pharmacy closes and ceases operation it shall notify the Board of the intended closing. At time of closing, the pharmacist-in-charge shall: A. Return the pharmacy license to the Board office, noting the closing date; B. Notify the Board as to the disposition of the prescription files, prescription drugs, insulin, hypodermic syringes and needles, contraceptive drugs and devices, chemicals, and nonprescription drugs; C. If the pharmacy that is closing has been computerized, give a printout of all patient profiles to the pharmacy that is receiving the prescription files; D. Ensure that all legend drugs are removed from the pharmacy at the time of closing and stored in a licensed pharmacy; legend drugs must not be stored elsewhere, including in the custody of a pharmacist; E. Inform the succeeding business occupying the premises and the landlord, if any, that it is unlawful to use the words "drugs," "drug store," or "pharmacy," or similar words in connection with the place of business unless it is a licensed pharmacy; and F. Take a controlled substances inventory as described in subitems (1) to (4). The inventory shall serve as the final inventory of the closing pharmacy and the initial inventory of the pharmacy receiving the controlled substances, and a copy of the inventory shall be included in the records of both. It is not necessary to file a copy of the inventory with the Drug Enforcement Administration unless requested by the regional administrator. (1). If controlled substance drugs are to be destroyed, the pharmacist-in-charge must contact the local Drug Enforcement Administration for instructions. (2). If controlled substance drugs, Schedule III-V, are being transferred, they shall be transferred on duplicate invoices, with each pharmacy keeping a copy. (3). If Schedule II narcotics are being transferred, the transferee must submit a new Drug Enforcement Administration 222 Form to the transferor for the Schedule II substances only. (4). If the Drug Enforcement Administration does not approve of the transfer, instructions must be given to the pharmacy that is closing to dispose of the drugs according to the written instructions provided by the regional director.

Which of the following information regarding Pharmacy Technician is/are TRUE? I. An applicant must be 16 years of age or older. II. An applicant shall present the board with evidence of high school graduation. III. An applicant shall possess a general educational development certificate equivalent. a. I only b. I and II only c. II and III only d. All

Answer: (c) II and III are true, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3850 Subpart 1g and 1h]. Effective January 1, 2012, the board shall not register as a pharmacy technician any individual who is less than 18 years of age. Effective January 1, 2013, the board shall not issue an initial pharmacy technician registration to any individual who does not present the board with evidence of high school graduation or possession of a general educational development certificate equivalent.

Which of the following products containing ephedrine can be lawfully sold over-the-counter without a prescription? I. Anorectal preparations containing less than 7.5 % ephedrine. II. Solid oral dosage forms containing 400 mg Guaifenesin with 25 mg ephedrine per dose. III. A dietary supplement known as Ma Huang. a. I only b. I and II only c. II and III only d. All

Answer: (c) II and III only, [Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.135 Subdivision 2(a),(b)]. A drug product containing ephedrine, its salts, optical isomers, and salts of optical isomers is exempt from prescription requirements if the drug product: (1). May be lawfully sold over the counter without a prescription under the federal Food, Drug, and Cosmetic Act, (2). Is labeled and marketed in a manner consistent with the pertinent OTC Tentative Final or Final Monograph; (3). Is manufactured and distributed for legitimate medicinal use in a manner that reduces or eliminates the likelihood of abuse; (4). Is not marketed, advertised, or labeled for the indication of stimulation, mental alertness, weight loss, muscle enhancement, appetite control, or energy; (5). Is in solid oral dosage forms, including soft gelatin caplets, that combine 400 milligrams of guaifenesin and 25 milligrams of ephedrine per dose, according to label instructions; or (6). Is an anorectal preparation containing not more than 5 % (NOT 7.5 %) ephedrine; and (7). Products containing ephedra or Ma Huang and lawfully marketed as dietary supplements under federal law.

To be entitled to examination by the board as a pharmacist the applicant shall be of: I. at least 19 years of age. II. good moral character. III. a graduate of the Board approved college of pharmacy. a. I only b. I and II only c. II and III only d. All

Answer: (c) II and III, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.10, Subdivision 1]. To be entitled to examination by the board as a pharmacist the applicant shall be of good moral character, at least 18 years of age, and shall be a graduate of the College of Pharmacy of the University of Minnesota or of a college or school of pharmacy in good standing of which the board shall be the judge and shall have completed internship requirements as prescribed by the board.

Every year, a pharmacy registration shall expire on which of the following dates? a. December 31 b. April 30 c. June 30 d. August 31

Answer: (c) June 30, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.19, Subdivision 1(a) and Chapter 6800 Section 6800.0400]. Each pharmacy license shall expire on June 30 of each year and shall be renewed annually by filing an application for license renewal, on or before June 1 of each year, together with a fee established in Minnesota Statutes, chapter 151. Renewal applications received on or after July 1 are subject to a late filing fee of an amount equal to 50 percent of the renewal fee in addition to the renewal fee.

All of the following are Schedule I controlled drugs EXCEPT: a. Heroin b. LSD c. Methylphenidate d. Marijuana

Answer: (c) Methylphenidate(Ritalin) is a Schedule II controlled drug, [Minnesota Administrative Rules Chapter 6800 Sec.6800.4220]. List of Schedule I controlled drugs: _____________________________ Difenoxin (Lyspafen) Dihydromorphine Heroin (Diacetylmorphine, diamorphine) Lysergic acid diethylamide (LSD, lysergide) Marijuana (Cannabis, marijuana) Mescaline Peyote

Compounding morphine sulfate suppositories for topical use should be classified as: a. Simple Compounding b. Simple-Moderate Compounding c. Moderate Compounding d. Complex Compounding

Answer: (c) Moderate Compounding. Moderate Compounding: Making a preparation that requires special calculations or procedures (such as calibration of dosage unit mold cavities) to determine quantities of components per preparation or per individualized dosage units; or making a preparation for which stability data for that specific formulation are not available. Examples include morphine sulfate Suppositories, diphenhydramine hydrochloride troches, and mixing two or more manufactured cream products when the stability of the mixture is not known.

How often shall assessments of automated distribution devices be performed? a. Daily b. Weekly c. Monthly d. Quarterly

Answer: (c) Monthly, [Minnesota Administrative Rules Chapter 6800 Sec.6800.2600 SubPart 3(J)]. (J). Assessments of automated distribution devices must be performed to ensure, at a minimum, that: (1). drugs are properly stored in their assigned locations and in pharmacy-approved configurations; (2). outdated drugs are removed and replaced; (3). only approved drugs are in the device; (4). inventory levels are appropriate based on usage; and (5). the device and drugs are secure. Each of the five requirements in item J must be assessed at least on a monthly basis, but all need not be assessed at the same time. Pharmacy personnel must conduct, at least monthly, an audit of controlled substances to ensure accuracy of distribution and proper record keeping.

In Minnesota, a pharmacist should not dispense any non-controlled drug if the prescription is presented: a. More than 180 days after the date of issuance. b. More than 90 days after the date of issuance. c. More than 365 days after the date of issuance. d. More than 30 days after the date of issuance.

Answer: (c) More than 365 days after the date of issuance, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3510]. No prescription may be filled or refilled more than 12 months after the date on which the prescription was issued. Refills originally authorized in excess of 12 months are void 12 months after the original date of issuance of the prescription. After 12 months from the date of issuance of a prescription, no additional authorizations may be accepted for that prescription. If the prescriber desires continued therapy, a new prescription must be generated and a new prescription number assigned.

Which of the following is/are classified as Schedule II controlled drug(s)? I. Heroin II. Morphine III. Pentobarbital a. I only b. I and II only c. II and III only d. All

Answer: (c) Morphine sulfate and Pentobarbital are classified as Schedule II controlled drugs, [Minnesota Administrative Rules Chapter 6800 Sec.6800.4220]. Heroin is classified as a Schedule I controlled drug, [Minnesota Administrative Rules Chapter 6800 Sec.6800.4210].

Who may determine the emergency drug supplies of emergency kits? a. Board of Pharmacy b. Pharmacy and Therapeutic Committee c. Quality Assurance and Assessment Committee d. Health Administrator of the State

Answer: (c) Quality Assurance and Assessment Committee, [Minnesota Administrative Rules Chapter 6800 Sec.6800.6700 SubPart 2]. A pharmacy may provide, upon a written or oral request from the quality assurance and assessment committee, limited supplies of drugs for use in an emergency kit. The drugs remain the property of the pharmacy. Only emergency drug supplies determined by the quality assurance and assessment committee necessary for patient care in life threatening emergencies may be made available. The drugs in the emergency kit are the responsibility of the pharmacist and, therefore, shall not be used or altered in any way except as outlined in this subpart.

For evaluating the skill of personnel to aseptically prepare CSPs, which of the following commercially available sterile fluid culture media shall be used? a. Polysorbate-Lecithin Digest Medium b. Spirulina-Tryptophan Digest Medium c. Soybean-Casein Digest Medium d. Leucine-Isoleucine Digest Medium

Answer: (c) Soybean-Casein Digest Medium. The skill of personnel to aseptically prepare CSPs shall be evaluated using sterile fluid bacterial culture media-fill verification, (i.e., sterile bacterial culture medium transfer via a sterile syringe and needle). Media fill testing is used to assess the quality of the aseptic skill of compounding personnel. Media-fill tests shall represent the most challenging or stressful conditions actually encountered by the personnel being evaluated when they prepare low- and medium-risk level CSPs and when sterilizing high risk level CSPs. A commercially available sterile fluid culture media, such as Soybean-Casein Digest Medium, that is able to promote exponential colonization of bacteria that are most likely to be transmitted to CSPs from the compounding personnel and environment is commonly used.

A pharmacy may provide to a nursing home a separate supply of medications containing the prophylaxis regimen for HIV currently recommended by _____________ for the prevention of HIV due to accidental contact with contaminated body fluids by health care workers. a. ASHP b. JNC HIV Guideline c. CDC d. PEDR

Answer: (c) the Centers for Disease Control (CDC), [Minnesota Administrative Rules Chapter 6800 Sec.6800.6800]. A pharmacy may provide to a nursing home a separate supply of medications containing the prophylaxis regimen for HIV currently recommended by the Centers for Disease Control for the prevention of HIV due to accidental contact with contaminated body fluids by health care workers.

Electronic data processing equipment, when used to store prescription information, must produce a hard copy daily summary of controlled substance transactions and be capable of producing a hard copy printout of legend drug transactions for previous: a. six months b. one year c. two years d. five years

Answer: (c) two years, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3950 Subpart 2 D]. Electronic data processing equipment, when used to store prescription information, must: 1. produce a hard copy daily summary of controlled substance transactions and be capable of producing a hard copy printout of legend drug transactions going back two years, except that if this information is already available in hard copy form it is not necessary to duplicate the data through a computer-generated hard copy; 2. be capable of recording and carrying in the record all dates of refills of any prescription drug order and the unique identifier of the pharmacist; 3. be capable of producing a patient profile indicating all drugs being taken and the dates and quantities of fills or refills of prescription drug orders dispensed for the patient and: (1). in the case of hospital or long-term care inpatients, these records shall be kept in the computer system or on hard copy and be immediately retrievable for two years; and (2). in all other cases the data shall be kept in the computer system and be immediately retrievable for at least two years; 4. be capable of producing a printout providing a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance. The audit trail must include the name of prescribing practitioner, the name and location of patient, the quantity dispensed on each refill, the date of dispensing of each refill, the name or unique identifier of the dispensing pharmacist, and the prescription number; 5. be capable of identifying any authorized changes in drug, quantity, or directions for use of any prescription drug order including the date of change, the identity or unique identifier of the individual making the change, and what the original information was; alternatively a new prescription drug order may be created for each authorized change; and 6. be capable of preventing unauthorized access, modification, or manipulation of patient prescription data.

What is the maximum quantity of hypodermic needles and syringes that can be sold by registered pharmacies to an individual person without a prescription? a. None b. 100 c. 5 d. 10

Answer: (d) 10, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.40 Subdivision 2]. 1. A registered pharmacy or its agent or a licensed pharmacist may sell, without a prescription, unused hypodermic needles and syringes in quantities of ten or fewer, provided the pharmacy or pharmacist complies with all of the requirements of Minnesota Pharmacy Law. 2. At any location where hypodermic needles and syringes are kept for retail sale under this subdivision, the needles and syringes shall be stored in a manner that makes them available only to authorized personnel and not openly available to customers. 3. No registered pharmacy or licensed pharmacist may advertise to the public the availability for retail sale, without a prescription, of hypodermic needles or syringes in quantities of ten or fewer. 4. A registered pharmacy or licensed pharmacist that sells hypodermic needles or syringes under this subdivision may give the purchaser the materials developed by the commissioner of health under section 325F.785.

How many hours of continuing education are required for a pharmacy technician's registration renewal? a. 5 hours b. 10 hours c. 15 hours d. 20 hours

Answer: (d) 20 hours, [Minnesota Administrative Rules Chapter 6800 Sec.6800.1500 SubPart 2a(A)]. No annual pharmacy technician registration renewal shall be issued unless the technician presents the board with satisfactory evidence of completion of 20 hours of approved continuing pharmacy technician education per two-year reporting period. Each reporting period shall end on July 31 of odd-numbered years.

How many hours of continuing education are required biennially under the Minnesota State Pharmacy Law? a. 10 b. 15 c. 20 d. 30

Answer: (d) 30 hours, [Minnesota Administrative Rules Chapter 6800 Sec.6800.1500 Subpart 1(C) and Subpart 2]. Continuing pharmacy education is a planned learning experience beyond a formal undergraduate degree program designed to promote the continual development of professional knowledge, professional skills, and professional attitudes on the part of the practitioners. No annual license renewal shall be issued to a pharmacist under Minnesota Statutes, until the pharmacist has submitted to the Board satisfactory evidence that the pharmacist has completed at least 30 hours of approved continuing education during the previous two-year period. Each reporting period shall end on September 30 of each even-numbered year.

A person or establishment may sell or distribute legend medical gases at retail to: I. a patient on the basis of a prescription from a practitioner II. a hospital III. a licensed pharmacy a. I only b. I and II only c. II and III only d. All

Answer: (d) All [Minnesota Administrative Rules Chapter 6800 Sec.6800.9921 and 9923]. Every person or establishment selling or distributing legend medical gases in Minnesota at retail that is not currently licensed as a pharmacy, pharmacist, medical gas manufacturer, medical gas wholesaler, or practitioner shall annually apply for registration by the board. Employees of an establishment need not register if the establishment is registered or has applied for registration. The certificate expires on December 1 of each year, and must be renewed annually. No person or establishment shall sell or distribute legend medical gases at retail to anyone other than: A. a patient on the basis of a prescription from a practitioner; OR B. a hospital, a practitioner , a licensed pharmacy, or other institution or person licensed to possess these drugs for use in the usual course of practice. The distributor of these items shall determine if the purchaser is licensed to possess them. No person or distributor may sell or distribute any legend medical gas product at retail without the manufacturer's intact federally required labeling.

Which of the following statements is/are TRUE under the Controlled Substance Act? I. An authorized agent of an individual practitioner may prepare a written prescription for the signature of the practitioner, provided that the practitioner, in the usual course of professional practice, has determined that there is a legitimate medical purpose for the prescription and has specified to the agent the required elements of the prescription. II. Where a DEA-registered individual practitioner has made a valid oral prescription for a controlled substance in Schedules III-V by conveying all the required prescription information to the practitioner's authorized agent, that agent may telephone the pharmacy and convey that prescription information to the pharmacist. III. In those situations in which an individual practitioner has issued a valid written prescription for a controlled substance, and the regulations permit the prescription to be transmitted by facsimile to a pharmacy the practitioner's agent may transmit the practitioner-signed prescription to the pharmacy by facsimile. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21 CFR 1306.04(a); 1306.05(a), (f), 21 CFR 1306.11(a), 1306.11(f), 1306.11(g), and 1306.21(a), 21 CFR 1306.03(b), 1306.21(a)]. 1. An authorized agent of an individual practitioner may prepare a written prescription for the signature of the practitioner, provided that the practitioner, in the usual course of professional practice, has determined that there is a legitimate medical purpose for the prescription and has specified to the agent the required elements of the prescription. . 2. Where a DEA-registered individual practitioner has made a valid oral prescription for a controlled substance in Schedules III-V by conveying all the required prescription information to the practitioner's authorized agent, that agent may telephone the pharmacy and convey that prescription information to the pharmacist. 3. In those situations in which an individual practitioner has issued a valid written prescription for a controlled substance, and the regulations permit the prescription to be transmitted by facsimile to a pharmacy, the practitioner's agent may transmit the practitioner-signed prescription to the pharmacy by facsimile.

Which of the following is/are TRUE regarding importing or exporting controlled substances listed in schedule II, III, IV or V for a personal medical use? I. A United States resident may import into the United States no more than 50 dosage units combined of all such controlled substances in the individual's possession that were obtained abroad for personal medical use. II. The controlled substance is in the original container in which it was dispensed to the individual. III. The individual makes a declaration to an appropriate official of the Bureau of Customs and Border Protection stating that the controlled substance is possessed for his/her personal use. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21CFR 1301.26]. Any individual who has in his/her possession a controlled substance listed in schedules II, III, IV, or V, which he/she has lawfully obtained for his/her personal medical use, or for administration to an animal accompanying him/her, may enter or depart the United States with such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C. 952-955), provided the following conditions are met: (a). The controlled substance is in the original container in which it was dispensed to the individual; and (b). The individual makes a declaration to an appropriate official of the Bureau of Customs and Border Protection stating: (1). That the controlled substance is possessed for his/her personal use, or for an animal accompanying him/her; and (2). The trade or chemical name and the symbol designating the schedule of the controlled substance if it appears on the container label, or, if such name does not appear on the label, the name and address of the pharmacy or practitioner who dispensed the substance and the prescription number. (c) In addition to (and not in lieu of) the foregoing requirements of this section, a United States resident may import into the United States no more than 50 dosage units combined of all such controlled substances in the individual's possession that were obtained abroad for personal medical use. (For purposes of this section, a United States resident is a person whose residence (i.e., place of general abode-- meaning one's principal, actual dwelling place in fact, without regard to intent) is in the United States.) This 50 dosage unit limitation does not apply to controlled substances lawfully obtained in the United States pursuant to a prescription issued by a DEA registrant.

The requirements of labeling do not apply when a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized provided that: I. Not more than 7-day supply of the controlled substance listed in Schedule II is dispensed at one time. II. The controlled substance listed in Schedule II is not in the possession of the ultimate user prior to the administration. III. The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21CFR Section 1306.14]. The requirements of labeling do not apply when a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized provided that: 1. Not more than 7-day supply of the controlled substance listed in Schedule II is dispensed at one time; 2. The controlled substance listed in Schedule II is not in the possession of the ultimate user prior to the administration; 3. The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II. 4. The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

No electronic DEA 222 order may be filled if: I. The order is not signed using a digital certificate issued by DEA. II. The digital certificate used had expired or had been revoked prior to signature. III. The purchaser's public key cannot validate the digital signature. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21CFR1305.25]. (a) No electronic DEA 222 order may be filled if: (1). The required data fields have not been completed. (2). The order is not signed using a digital certificate issued by DEA. (3). The digital certificate used had expired or had been revoked prior to signature. (4). The purchaser's public key cannot validate the digital signature. (5). The validation of the order shows that the order is invalid for any reason. (b). If an order cannot be filled for any reason under this section, the supplier must notify the purchaser and provide a statement as to the reason (e.g., improperly prepared or altered). A supplier may, for any reason, refuse to accept any order, and if a supplier refuses to accept the order, a statement that the order is not accepted is sufficient for purposes of this paragraph. (c). When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must electronically link the statement of nonacceptance to the original order. The original order and the statement must be retained in accordance with §1305.27. (d). Neither a purchaser nor a supplier may correct a defective order; the purchaser must issue a new order for the order to be filled.

In which of the following instances shall a pharmacy require a new license? I. the addition or deletion of one or more partners in a partnership. II. the change of ownership of 20% or more of the issued voting stock of a corporation pharmacy. III. the pharmacy has changed from sole proprietorship to s-corporation. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.0500 A-to-E]. A separate license shall be required for each pharmacy and is not transferable. The following shall be considered a transfer requiring relicensure: A. the sale of all or substantially all of the assets of the pharmacy; B. the addition or deletion of one or more partners in a partnership to which a pharmacy license has been issued; C. the change of ownership of 20 % or more of the issued voting stock of a corporation pharmacy since the issuance of the license or the last renewal; this does not apply to any corporation the voting stock of which is actively traded on any securities exchange or in any over-the-counter market; D. the change in ownership from one form to another: sole proprietor, partnership, or corporation; or E. the addition, deletion, or change of categories of licensure. For a transfer of ownership, the new owner must submit a completed pharmacy license application prior to the effective date of the transfer. Upon a transfer of ownership, the new owner can continue operation of the pharmacy under the license issued to the prior owner for 14 days after the effective date of the change of ownership or until the board issues a new license, whichever is earlier. After the 14-day period, the license issued to the prior owner is void and must be surrendered to the director of the board.

Which of the following should be part of a patient's counseling? I: name and description of the drug II: techniques for self-monitoring of drug therapy III: action to be taken in the event of a missed dose a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.0910 SubPart 2(A)]. To optimize drug therapy, a pharmacist shall counsel the patient or patient's agent regarding: (1). the name and description of the drug; (2). the dosage form, dose, route of administration, and duration of drug therapy; (3). intended use of the drug and expected action; (4). special directions and precautions for preparation, administration, and use by the patient; (5). common severe side effects, adverse effects, or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur; (6). techniques for self-monitoring of drug therapy; (7). proper storage; (8). prescription refill information; (9). action to be taken in the event of a missed dose; and (10). pharmacist comments relevant to the patient's drug therapy, including any other information peculiar to the specific patient or drug.

Which of the following is/are TRUE about closing a pharmacy in Minnesota? I. publish the notice in a local newspaper for one week prior to the date on which the pharmacy is to be closed. II. a direct mailing to patients who have had at least one prescription filled at that pharmacy during the six months preceding the date of closing. III. distribute the notice to patients who are picking up prescriptions at least 30 days prior to the date on which the pharmacy will be closed. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.1010 SubPart 3]. A licensed pharmacy must provide the following public notification when closing a pharmacy: distribution, by at least one of the following means, of a notice that informs patients that the pharmacy will close on a specified date and that gives the name, address, and telephone number of the pharmacy to which prescription files will be transferred: A. publication of the notice in a local newspaper for one week prior to the date on which the pharmacy is to be closed; B. a direct mailing to patients who have had at least one prescription filled at that pharmacy during the six months preceding the date of closing, with the mailing designed to reach patients no later than one business day prior to the closing; and C. distribution of the notice to patients who are picking up prescriptions at least 30 days prior to the date on which the pharmacy will be closed. In the case of patients who are residents of long-term care facilities, the pharmacy shall provide a written notice to the patients, the caregivers of the patients, or the long-term care facilities in which the patients reside at least 30 days prior to the date on which the pharmacy will be closed.

Each pharmacy in Minnesota shall have on file: I. Goodman and Gilman's The Pharmacological Basis of Therapeutics II. Drug Information Handbook III. United States Pharmacopeia - National Formulary a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.1050 SubPart 1]. In addition to the most recent editions of the laws relating to the practice of pharmacy, the rules of the Board of Pharmacy, and the current copy of the Drug Enforcement Agency regulations, Code of Federal Regulations, title 21, parts 1300 to 1316, each pharmacy in Minnesota must have on file at least one current reference from each of the categories in items A to C. At least one dosage and toxicology reference must be in hard copy form that is appropriate to the majority of the patient base of the pharmacy. An equivalent reference approved by the board in writing may be used in an appropriate category. A. Examples of pharmacotherapy references are: (1). Goodman and Gilman's The Pharmacological Basis of Therapeutics; (2). Applied Therapeutics: The Clinical Use of Drugs; (3). Pharmacotherapy: A Pathophysiologic Approach; and (4). Conn's Current Therapy. B. Examples of dosage and toxicology references are: (1). American Hospital Formulary Service; (2). Facts and Comparisons; and (3). Drug Information Handbook. C. Examples of general references are: (1). Handbook of Nonprescription Drugs; (2). Physician's Desk Reference; (3). Remington: The Science and Practice of Pharmacy; (4). United States Pharmacopeia - National Formulary; (5). United States Pharmacopeia - Pharmacists' Pharmacopeia; (6). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations; and (7). The Merck Manual.

Each pharmacy must have which of the following equipment(s) on its premise? I. Class A prescription balance. II. One set of accurate metric weights from 50 mg to 100 g. III. A refrigerator a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.1050 Subpart 2]. Each pharmacy must have the following minimum equipment, clean and in good working order: A. one prescription balance, Class A as defined in United States Pharmacopeia - National Formulary, with one set of accurate metric weights from 50 mg to 100 g, or an electronic balance of equal or greater accuracy; B. measuring devices capable of accurately measuring volumes from 1 ml to at least 500 ml; C. mortars, pestles, spatulas, funnels, stirring rods, and heating apparatus as necessary to meet the needs of that pharmacy; D. other equipment as necessary to comply with the requirements of United States Pharmacopeia, chapter 795; E. a refrigerator used only for drug storage or a separate compartment used only for drug storage within a general use refrigerator, manual, electromechanical, or electronic temperature recording equipment, devices, or logs shall be used to document proper storage of prescription drugs every business day; F. a sink with hot and cold running water; and G. a toilet with a hand-washing lavatory and disposable towels in a location that is reasonably accessible. In addition to the requirements of subparts 1 and 2, pharmacies preparing compounded sterile products are required to have: A. minimum equipment to comply with the United States Pharmacopeia, chapter 797, appropriate to risk-level requirements; B. current reference materials or books for sterile products or intravenous incompatibilities; and C. a current copy of United States Pharmacopeia, chapter 797.

A pharmacist currently licensed in Minnesota who is not in active practice in Minnesota may apply for an inactive status license with the board. Which of the following information is/are TRUE? I. Requests for inactive status licensure shall be made at the time of license renewal. II. The board shall grant an inactive status license to a pharmacist making the request on submission of a sworn statement stating that the pharmacist is not in active practice in Minnesota. III. A pharmacist granted an inactive status license must continue to pay the renewal fee for licensure but shall not be required to comply with the continuing education requirements of the board. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.1210]. A pharmacist currently licensed in Minnesota who is not in active practice in Minnesota may apply for an inactive status license with the board. Requests for inactive status licensure shall be made at the time of license renewal. The board shall grant an inactive status license to a pharmacist making the request on submission of a sworn statement stating that the pharmacist is not in active practice in Minnesota. A pharmacist granted an inactive status license must continue to pay the renewal fee for licensure but shall not be required to comply with the continuing education requirements of the board. A pharmacist granted inactive status is not authorized to practice pharmacy in Minnesota while on inactive status. If an individual's license is on inactive status and that individual maintains an active status license in good standing in another state that requires continuing education, the individual may reactivate the Minnesota license by showing compliance with the continuing education requirements of the other state. If an individual in this category has been on inactive status in Minnesota for longer than five years, the individual must also take and pass the jurisprudence examination described in part 6800.1300, subpart 5, offered to candidates for licensure by reciprocity. If an individual's license is on inactive status in Minnesota and that individual is not licensed in another state that requires continuing education and now seeks to reactivate the license in Minnesota, the individual must show that continuing pharmaceutical education has been completed at a rate of 15 hours per year for each year that the license has been on inactive status up to a maximum of 75 hours. If the license has been on inactive status for longer than five years, the individual must also take and pass the jurisprudence examination described in part 6800.1300, subpart 5, offered to candidates for licensure by reciprocity.

Which of the following information is/are TRUE when a when a pharmacist is on a meal break? I. A pharmacy may, but is not required to, close. II. Pharmacy technicians, pharmacist-interns, and other supportive staff, authorized by the pharmacist on duty, may continue to perform duties. III. Only prescriptions that have been certified by a pharmacist and not require counseling may be dispensed. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.2160 ]. A pharmacy shall not require a pharmacist, pharmacist-intern, or pharmacy technician to work longer than 12 continuous hours per day, inclusive of the breaks. Requirements for breaks: A. A pharmacist, pharmacist-intern, or pharmacy technician working longer than six continuous hours per day shall be allowed during that time period to take a 30-minute, uninterrupted break. B. A pharmacist, pharmacist-intern, or pharmacy technician shall be allowed adequate time from work within each four consecutive hours of work to utilize the nearest convenient restroom. C. A pharmacy may, but is not required to, close when a pharmacist is on a break. If the pharmacy does not close, the pharmacist shall either remain within the licensed pharmacy or within the establishment in which the licensed pharmacy is located in order to be available for emergencies. In addition, the following apply: (1). pharmacy technicians, pharmacist-interns, and other supportive staff, authorized by the pharmacist on duty, may continue to perform duties; (2). no duties reserved to pharmacists and pharmacist-interns under any part of this chapter, or that require the professional judgment of a pharmacist, may be performed by pharmacy technicians or other supportive staff; and (3). only prescriptions that have been certified by a pharmacist, as required by part 6800.3100, may be dispensed while the pharmacist is on break; except that prescriptions that require counseling by a pharmacist, including all new prescriptions and those refill prescriptions for which a pharmacist has determined that counseling is necessary, may be dispensed only if the following conditions are met: (a). the pharmacy develops a list of drugs that may not be dispensed while a pharmacist is taking an allowed break, without the patient receiving counseling from a pharmacist, when counseling would normally be required; (b). the patient, or other individual who is picking up the prescription on behalf of the patient, is told that the pharmacist is on a break and is offered the chance to wait until the pharmacist returns from break in order to receive counseling; (c). if the patient or caregiver declines to wait, a telephone number at which the patient or a caregiver can be reached is obtained; (d). after returning from the break, the pharmacist makes a reasonable effort to contact the patient or a caregiver by telephone and provides counseling; and (e). the pharmacist documents the counseling that was provided or documents why counseling was not provided, including a description of the efforts made to contact the patient or caregiver. The documentation shall be retained by the pharmacy, and be made available for inspection by the board or its authorized representatives, for a period of at least two years. D. In pharmacies staffed by two or more pharmacists, the pharmacists shall stagger breaks so that at least one pharmacist remains on duty at all times that the pharmacy remains open for the transaction of business.

What are the duties of a pharmacist-in-charge? I. To establish policies and procedures for the employees of the pharmacy for the procurement, storage, compounding, and dispensing of drugs. II. To establish and supervise the method and manner for the storing and safekeeping of drugs. III. To supervise all of the professional employees of the pharmacy. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.2400 Subpart 1]. Duties of pharmacist-in-charge: __________________________ A. To establish policies and procedures for the employees of the pharmacy for the procurement, storage, compounding, and dispensing of drugs and the communication of information to the public in relation to drug therapy; B. To supervise all of the professional employees of the pharmacy; C. To assure that all persons participating in an internship, residency, or fellowship program at the pharmacy are appropriately licensed or registered with the Board; D. To supervise all of the nonprofessional employees of the pharmacy insofar as their duties relate to the procurement, sale, and/or storage of drugs; E. To develop appropriate detailed written procedures directing activities of pharmacy technicians and to make these procedures available to the Board, and to ensure that all persons working as pharmacy technicians are registered with the Board; F. To establish and supervise the method and manner for the storing and safekeeping of drugs; G. To establish and supervise the record-keeping system for the purchase, sale, possession, storage, safekeeping, and return of drugs; H. To notify the Board immediately upon receiving knowledge that his or her services as pharmacist-in-charge have been or will be terminated; I. To respond to deficiency reports; and J. To ensure that staffing and operational quality assurance policies are developed, implemented, and followed for the purpose of decreasing and monitoring prescription errors.

Non-controlled substance drugs may be stored in the open matrix drawer if they are: I. large bulky items such as intravenous infusion bags. II. Non-legend drugs that are safely arranged. III. Legend drugs that are not look-alike products. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.2600 SubPart 3(E)]. The Matrix Drawer is a high-capacity, low security drawer that is suitable for large quantities of non-controlled medications. The Double-Deep Matrix Drawer accommodates large quantities of medication or larger items such as large vials and premixed IV bags. The use of an open matrix drawer that allows access to more than one drug at a time must be limited to non-controlled substance drugs, unless the entire drawer contains only one controlled substance drug product. Non-controlled substance drugs may be stored in the open matrix drawer if they are: (1). large bulky items such as intravenous infusion bags; (2). non-legend drugs that are safely arranged; (3). legend drugs that are not look-alike products; or (4). drugs properly packaged and labeled for an individual patient.

Removal of a high-alert drug from the system must be checked by a second licensed health care professional to ensure that the prescription drug order is being correctly interpreted and that the correct drug has been removed. This requirement does not apply when: I. a pharmacist has reviewed and approved the prescription drug order prior to the removal of the high-alert drug from the system. II. a licensed practitioner controls the ordering, preparation, and administration of the medication during a medical procedure. III. the prescribing practitioner has determined that the high-alert drug must be administered before the drug order can be reviewed by a pharmacist. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.2600 SubPart 3(F)]. Removal of a high-alert drug from the system must be checked by a second licensed health care professional to ensure that the prescription drug order is being correctly interpreted and that the correct drug has been removed. This requirement does not apply when: (1). a pharmacist has reviewed and approved the prescription drug order prior to the removal of the high-alert drug from the system; (2). a licensed practitioner controls the ordering, preparation, and administration of the medication during a medical procedure; or (3). the prescribing practitioner has determined that the high-alert drug must be administered before the drug order can be reviewed by a pharmacist or a second licensed health care professional. A pharmacist must certify all packaging, labeling, and stocking associated with the use of an automated drug distribution system. Unless the certification process utilizes a fail-safe bar coding, certification must be performed by a pharmacist. Certification must be documented and records must be retained for at least two years. Automated distribution devices must be secured or kept in a locked medication room when not in actual use. Unused drugs must be returned to the pharmacy or to the system's secure, designated return bin or equivalent area. Restocking of the system may only be performed by designated pharmacy personnel with required certification.

Drugs from nursing homes and assisted living facilities may be returned to the dispensing pharmacy. The returned drugs may be redispensed if: I. the consultant pharmacist can assure proper storage conditions for the drugs in the facilit. II. the drugs are returned to the same pharmacy, which dispensed the drugs. III. the facility has 24-hour, on-site licensed nursing coverage seven days a week. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.2700 Subpart 2]. Drugs from nursing homes and assisted living facilities may be returned to the dispensing pharmacy. The returned drugs may be redispensed if: A. the consultant pharmacist can assure proper storage conditions for the drugs in the facility as specified in the United States Pharmacopeia and the drugs are stored within the facility in a secure area; B. the facility has 24-hour, on-site licensed nursing coverage seven days a week; C. the drugs are returned to the same pharmacy, which dispensed the drugs; D. the integrity of such packaging remains intact (no reconstituted drugs, drugs requiring refrigeration, or controlled substances may be so returned); and E. the drugs are received by the pharmacy in the original manufacturer's packaging or pharmacist packager's unit-dose, unit-of-use, or strip packaging with each tablet or capsule individually wrapped and labeled, or in blister cards, which indicate the drug name and strength, the packager's name, and the manufacturer's or packager's lot or batch number.

A pharmacy may deliver filled prescriptions at the place of employment of the patient or a designated caregiver of the patient only if the pharmacy: I. obtains and documents the authorization of the patient or patient's caregiver for delivery at the place of employment. II. ensures the filled prescription order is delivered directly to the patient or the patient's caregiver as authorized. III. ensures the security of protected health information. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3000 SubPart 1 A]. A pharmacy may deliver filled prescriptions at the place of employment of the patient or a designated caregiver of the patient only if the pharmacy: 1. obtains and documents the authorization of the patient or patient's caregiver for delivery at the place of employment. 2. ensures the filled prescription order is delivered directly to the patient or the patient's caregiver as authorized. 3. ensures the security of protected health information.

Which of the following should be part of Drug Utilization Review? I. overutilization or underutilization. II. drug-disease contraindications. III. clinical abuse or misuse. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3110 SubPart 4]. Upon receiving a prescription drug order or prescription refill request for a patient, a pharmacist shall examine the patient's profile record and conduct a prospective drug review to identify: A. overutilization or underutilization; B. therapeutic duplication; C. drug-disease contraindications; D. drug-drug interactions; E. incorrect drug dosage or duration of drug treatment; F. drug-allergy interactions; or G. clinical abuse or misuse.

Prescription drug orders that are entered into a computer system but never dispensed to the patient may be transferred to another pharmacy if: I. all prescription drug order information has been entered into the computer system of the transferring pharmacy. II. the information is displayed on the patient's profile in a manner that indicates the prescription drug order was not filled at the transferring pharmacy. III. there is present, either in the computer system or on the hard copy prescription drug order, the unique identifier of the person who entered the prescription drug order information into the system and of the pharmacist who certified this entry. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3120 SubPart 8a]. Prescription drug orders that are entered into a computer system but never dispensed to the patient may be transferred to another pharmacy if: 1. all prescription drug order information has been entered into the computer system of the transferring pharmacy. 2. the information is displayed on the patient's profile in a manner that indicates the prescription drug order was not filled at the transferring pharmacy. 3. there is present, either in the computer system or on the hard copy prescription drug order, the unique identifier of the person who entered the prescription drug order information into the system and of the pharmacist who certified this entry and of the pharmacist who performed the quality assurance verification as required by part 6800.3950, subpart 4. If the quality assurance verification has not occurred, then the prescription information exchanged must be from the original written prescription drug order.

A pharmacy may transfer prescription information for the purpose of refilling a prescription if the information is communicated directly by: I. one licensed pharmacist to another licensed pharmacist II. one licensed pharmacist to another licensed pharmacist-intern III. one licensed pharmacist-intern to another licensed pharmacist-intern a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3120 Subpart 2]. A pharmacy may transfer prescription drug order information for the purpose of refilling a prescription if the information is communicated directly by one licensed pharmacist or registered intern to another licensed pharmacist or registered intern. Schedule II prescriptions may not be transferred. Schedules III-V prescriptions may be transferred in accordance with the limitations placed on such transfers by the Drug Enforcement Administration (DEA). The transferring pharmacist or intern shall: A. write the word "VOID" across the face of the current prescription drug order to make it invalid or, if records are electronically maintained, void all remaining refills previously authorized and carried in the electronic record; B. record on the reverse side of the invalidated prescription drug order or in the electronically maintained record of the prescription drug order the name, address, and telephone number of the receiving pharmacy and the name of the receiving pharmacist or intern; and C. record the date of the transfer. Recording of prescription drug order transfers by cancellation of the electronic version of the prescription drug order is acceptable only when the quality assurance check required by part 6800.3950, subpart 4, has been completed on the prescription drug order being transferred. For controlled substances in Schedules III-V, parts 6800.4230 to 6800.4250, the transferring pharmacist or intern shall also record on the reverse side of the invalidated prescription drug order or in the electronically maintained record of the prescription drug order, the Drug Enforcement Administration registration number of the receiving pharmacy and the names of the receiving and transferring pharmacists or interns. The pharmacist or intern receiving the transferred prescription drug order information shall write the word "transfer," "copy," or a word of similar import on the face of the transferred prescription, and shall obtain from the transferring pharmacist or intern all information required by law to be on a prescription, plus: A. the date of issuance and of filling of the original prescription; B. the original number of refills authorized; C. the number of valid refills remaining; D. the date of last refill from original prescription; E. the original prescription number from which the prescription information was transferred; and F. the transferring pharmacy's name, address, and telephone number and the name of the transferring pharmacist or intern. In the case of a controlled substance listed in Schedules III-V, parts 6800.4230 to 6800.4250, the receiving pharmacist or intern must obtain the transferring pharmacy's Drug Enforcement Administration registration number. Retention of prescription: The transferring pharmacist shall keep the original prescription for at least two years from the date of last filling. The receiving pharmacist shall keep the transferred prescription for at least two years from the date of last filling.

The label for a filled veterinary prescription that is dispensed by a licensed pharmacy must include: I. In the case of non-food-producing animals, the name of the client or animal. II. In the case of food-producing animals, the name of the owner and the specific name and address of the facility at which the filled prescription will be used. III. Identification of the species for which the drug is prescribed or ordered. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3400 SubPart 4]. The label for a filled veterinary prescription that is dispensed by a licensed pharmacy must include: A. in the case of non-food-producing animals, the name of the client or animal. In the case of food-producing animals, the name of the owner and the specific name and address of the facility at which the filled prescription will be used; B. identification of the species for which the drug is prescribed or ordered; C. the name, strength, and quantity of the drug, except when specified by the prescriber to the contrary. In the case of combining premanufactured drug products, the names of the products, or category of use may suffice; D. the name of the manufacturer or distributor of the finished dosage form of the drug; E. the date of issue; F. directions for use; G. withdrawal time, excluding non-food-producing animals; H. cautionary statements if appropriate for the drug; I. the name, address, and telephone number of the pharmacy, except that central service pharmacies must use the name, address, and telephone number of the pharmacy dispensing the medication to the client; J. the name and address of the prescribing veterinarian, except that the address of the prescribing veterinarian is not required if the prescription is for a non-food-producing animal; and K. the prescription number. When the veterinary drug is in the manufacturer's original package and the information that is required on the label includes the drug or drugs, strength of the drug or drugs, directions for use, withdrawal time for food-producing animals, and cautionary statements, a label will be required on each individual bottle or package.

All drugs dispensed to or for a patient shall be labeled with: I. name of prescribing practitioner. II. name, address, and telephone number of pharmacy. III. name of manufacturer. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3400 Subpart 1(F), (A)-to-(K)]. All drugs dispensed to or for a patient, other than an inpatient of a hospital shall be labeled with the following information: A. name, address, and telephone number of pharmacy, central service pharmacies shall use the name, address, and telephone number of the pharmacy distributing the medication to the patient; B. patient's name; C. prescription number; D. name of prescribing practitioner; E. directions for use; F. name of manufacturer or distributor of the finished dosage form of the drug; G. auxiliary labels as needed; H. date of original issue or renewal; I. generic or trade name of drug and strength, except when specified by prescriber to the contrary. In the case of combining premanufactured drug products, the names of the products, or a category of use name shall suffice. In the case of compounding basic pharmaceutical ingredients, the common pharmaceutical name, if such exists, the names and strengths of the principle active ingredients or a category of use label shall suffice; J. prescriptions filled as part of a central service operation shall bear a unique identifier to indicate that the prescription was filled at a central service pharmacy; and K. after July 1, 2008, any dispensed prescription medication shall be labeled with its physical description, including any identification code that may appear on tablets and capsules.

Intravenous admixture drugs dispensed to or for a patient, other than a hospitalized patient, shall include: I. date of compounding. II. administration times, administration frequency, or both. III. infusion or administration rate. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3450 SubPart 1 and 2]. Intravenous admixture drugs dispensed to or for a patient, other than a hospitalized patient, shall include: A. name, address, and telephone number of the pharmacy filling the prescription drug order, except that central service pharmacies shall use the name, address, and telephone number of the pharmacy dispensing the medication to the patient; B. patient's name; C. prescription number; D. name of prescribing practitioner; E. directions for use; F. name of manufacturer or distributor of the finished dosage form of the drug; G. auxiliary labels as needed; H. date of original issue or renewal; I. generic or trade name of drug and strength, except when specified by prescriber to the contrary; J. date of compounding; K. beyond-use date; L. storage requirements if other than room temperature; M. infusion or administration rate; N. administration times, administration frequency, or both; and O. other accessory cautionary information which in the professional judgment of the pharmacist is necessary or desirable for proper use by and safety of the patient. When an additional drug is added to intravenous admixtures, the admixtures shall be labeled on the original label or with a distinctive supplementary label indicating the name and the amount of the drug added, date and time of addition and expiration, and the unique identifier of the person adding the drug.

Which of the following drugs may be included in the unit dose system under the Minnesota State Pharmacy law? I. Schedule II controlled drugs II. Schedule III controlled drugs III. Schedule IV controlled drugs a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3750 Subpart 2 and Subpart 6]. The unit dose system is that drug distribution system which is pharmacy based and which uses unit dose packaging in a manner which removes traditional drug stocks from patient care areas. A unit dose system shall be under the control of the pharmacist-in-charge. The act of drug dispensing is reserved for licensed pharmacists and registered pharmacist-interns acting under the supervision of licensed pharmacists. Schedule II, III, and IV controlled substances may be included in the unit dose system if the methods of including such drugs in the system are in compliance with applicable federal and state laws and rules.

A Unit dose packaging, when dispensed to a patient, shall be labeled with: I. the name and location of the patient. II. name of the prescribing practitioner. III. the directions for use. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3750 Subpart 2]. Unit dose packaging is the packaging of individual doses of medication in containers which will preserve the identity and integrity of the drug from the point of packaging to the point of administration to the patient. Packaging may be accomplished by a manufacturer or by a pharmacy. Individual doses of medication shall be properly labeled from the manufacturer with the name of the drug, dosage form and strength, manufacturer's name and lot number, and expiration date of all time dated drugs, or labeled in accordance with part 6800.3200 if prepackaged by the pharmacy. Unit dose packaging may provide individual doses of medication attached to each other by placement in a card or other container. Such packaging shall be labeled in accordance with part 6800.3200 in such a manner as to provide continuous identification of the contents and, when dispensed, the name and location of the patient, name of the prescribing practitioner, prescription number, date, the directions for use, and identification of the pharmacy.

The basic ratio of pharmacy technicians to pharmacists on duty in a pharmacy is two technicians to one pharmacist. This ratio may be increased to three technicians to the one pharmacist in which of the following situations? I. when a pharmacy technician is preparing intravenous admixture preparation. II. when a pharmacy technician is preparing patient specific prescriptions in unit dose packaging. III. when a pharmacy technician is prepackaging the drug. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3850 SubPart 6]. The basic ratio of pharmacy technicians to pharmacists on duty in a pharmacy is two technicians to one pharmacist. Specific functions are excepted from the basic ratio as follows: A. intravenous admixture preparation, 3:1; B. setting up or preparing patient specific prescriptions in unit dose or modified unit dose packaging, 3:1; C. prepackaging, 3:1; and D. compounding, 3:1. Personnel used solely for clerical duties such as typing or keyboarding that does not involve prescription data entry, record keeping, filing, billing, and completing sales transactions need not be included when determining compliance with the ratios listed in this part. Personnel used solely for the delivery of filled prescription drug orders need not be included when determining compliance with the ratios listed in this part. A pharmacist-intern submitting hours toward completion of the 1,600-hour requirement is not considered a pharmacy technician for the purpose of determining the number of pharmacy technicians supervised by a licensed pharmacist.

Which of the following statements are TRUE regarding quality assurance plans for new prescriptions under Minnesota Pharmacy Law? I. A pharmacy must develop and implement a written quality assurance plan that includes the pharmacist comparing the original written prescription or an image of the original written prescription, to the information entered into the computer. II. The process must not occur prior to two hours after the prescription has been initially certified. III. The whole process must be completed within 72 hours after the prescription is initially certified. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3950 Subpart 4(A),(B)]. 1. A pharmacy must develop and implement a written quality assurance plan that includes a pharmacist, or a pharmacist-intern working under the immediate and direct supervision of a pharmacist, comparing the original written prescription or an image of the original written prescription, to the information entered into the computer, and documenting the completion and accuracy of this comparison with the date and unique identifier of the pharmacist or pharmacist-intern completing the task. 2. This process must not occur prior to two hours after the prescription has been initially certified, unless it is completed by a second individual pharmacist as soon as possible after the initial certification has occurred. The process must be completed within 72 hours. 3. Hospitals providing inpatient pharmacy services may elect instead to develop a plan to provide safeguards against errors being made and perpetuated due to inaccurate prescription data being entered into the pharmacy's computer. This written quality assurance plan shall be made available to the Board surveyors upon request. 4. If dispensing information is lost due to unscheduled system interruption, the Board of Pharmacy shall be notified within 72 hours.

Which of the following is/are classified as Schedule IV controlled drug(s)? I. Oxazepam II. Zaleplon III. Butorphanol a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.4240].

Immediate and direct supervision by a licensed pharmacist is not required when an intern: I. gathers information for the purpose of formulating a pharmaceutical care plan II. making a drug therapy recommendation III. provides patient counseling a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.5400 SubPart 4b]. Immediate and direct supervision by a licensed pharmacist is not required when an intern completes: a. a medication history, b. gathers information for the purpose of formulating a pharmaceutical care plan or making a drug therapy recommendation, c. conducts educational activities for patients or staff, d. provides patient counseling, e. participates in patient rounds, or f. performs similar tasks that do not involve dispensing and compounding. However, all drug therapy and related recommendations that an intern proposes to make to other health professionals and patients must be reviewed and approved by a licensed pharmacist before they are made. An intern's supervising pharmacist is responsible for the accuracy and completeness of statements made by the intern while providing counseling to patients or health-related education to patients or staff.

Which of the following is/are TRUE about dispensing Schedule II controlled substances in the case of an emergency situations? I. The quantity prescribed and dispensed should be limited to treat the patient during the emergency period. II. The prescription shall be immediately reduced to writing by the attending pharmacist and contained all the information required by the law. III. The authorized prescriber shall deliver the written prescription for the emergency quantity prescribed to the dispensing pharmacy within 7 days after authorizing an emergency oral prescription. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.6200 Subpart 3(A),(B),(C) and Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.11 Subdivision 1 and 21CFR1306.11(d)(1-to-4)]. The quantity prescribed and dispensed should be limited to treat the patient during the emergency period. The prescription shall be immediately reduced to writing by the attending pharmacist and contained all the information required by the law. The authorized prescriber shall deliver the written prescription for the emergency quantity prescribed to the dispensing pharmacy within 7 days after authorizing an emergency oral prescription. Further, the pharmacist must notify DEA if the prescription is not received.

Access to the emergency kit is limited to: I. a licensed professional nurse II. a licensed medical practitioner III. a licensed consultant pharmacist a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.6700 SubPart 3(C)]. Access to the emergency kit is limited to the following individuals: (1). a licensed professional nurse who is employed by the facility and who has been directed by a physician to administer a drug from the kit; (2). a consultant pharmacist or other licensed pharmacist designated by the facility's pharmaceutical services committee; or (3). a licensed medical practitioner.

The responsibilities and duties of the hospital pharmacist-in-charge may include: I. cooperating in the teaching and research programs of the hospital. II. the maintaining of a stock of antidotes and emergency drugs in the hospital. III. the development of a hospital formulary system. a. I only b. III only c. I and II only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.7400 Subpart 4]. The responsibilities and duties of the hospital pharmacist-in-charge include at least the following specific duties: A. the procurement, identification, security, storage, and distribution of all drugs, as well as the disposition of drugs whose effectiveness has expired or which, for other reasons, are deemed no longer usable; B. the development, implementation, coordination, supervision, and review of pharmaceutical services in the hospital and policies related thereto; C. the supervision of the preparation and sterilization of parenteral drugs in the hospital; D. the supervision of bulk compounding of pharmaceuticals; E. the establishment of specifications for procurement of drugs and chemicals for direct patient use; F. the development of a hospital formulary system; G. the dispensing of drugs and chemicals for direct patient use; H. the maintaining of a stock of antidotes and emergency drugs in the hospital; I. the maintaining of pharmaceutical service records; and J. cooperating in the teaching and research programs of the hospital. The pharmacist's span of supervision shall extend to all areas of the hospital where drugs are stored. No less than every month inspections of these areas shall be conducted and substantiated by records so as to verify at least proper drug storage, documentation of distribution and administration of controlled substances, absence of outdated drugs, and the integrity of the required emergency drug supply.

Which of the following information is/are TRUE ABOUT wasting of controlled substances doses under the Minnesota Pharmacy Law? I. Wasting of doses must be carried out by two licensed individuals who are authorized to have access to controlled substances. II. The wasting of doses must be documented, with the accuracy of the documentation being certified by the licensed individuals who carried out the wasting. III. Certification must include the signature or other unique identifier of the licensed individuals who carried out the wasting. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.7520 Subp. 1 (S)(2)]. 1. Wasting of doses must be carried out by two licensed individuals who are authorized to have access to controlled substances. 2. The wasting of doses must be documented, with the accuracy of the documentation being certified by the licensed individuals who carried out the wasting. 3. Certification must include the signature or other unique identifier of the licensed individuals who carried out the wasting.

Which of the following is/are TRUE about withdrawing limited doses of drugs for administration to inpatients in emergencies when the pharmacy is closed? I. The designated registered nurse may make emergency withdrawal of a dose required by a patient. II. The designated registered nurse withdrawing the drug from a bulk stock container or unit dose packaging bin shall place upon the record of withdrawal the container from which the limited doses were taken so that the withdrawal may be verified by the pharmacist. III. The designated registered nurse withdrawing from a bulk stock container the limited doses for administration shall leave in the pharmacy, on a form developed by the pharmacy, a record of the drugs withdrawn showing the patient's name, the name of the drug and dose prescribed, drug strength, the amount taken, the time and date, and the signature of nurse withdrawing drug. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.7530 SubPart 3]. Only a pharmacist may have access to the pharmacy except in the following situations and under the following conditions set forth in subparts 2 and 3. Subp. 2: In the case of disaster, the hospital administrator may allow access for purposes of emergency maintenance, disaster prevention and control, and patient safety. Subp. 3: For purposes of withdrawing limited doses of drugs for administration to inpatients in emergencies when the pharmacy is closed, a designated registered nurse may make emergency withdrawal of a dose required by a patient. Only a designated registered nurse in any given shift may have emergency access. The person withdrawing from a bulk stock container the limited doses for administration shall leave in the pharmacy, on a form developed by the pharmacy, a record of the drugs withdrawn showing the patient's name, the name of the drug and dose prescribed, drug strength, the amount taken, the time and date, and the signature of nurse withdrawing drug. The person withdrawing the drug from a bulk stock container or unit dose packaging bin shall place upon the record of withdrawal the container from which the limited doses were taken so that the withdrawal may be verified by the pharmacist. Subp. 4: The pharmacist-in-charge shall develop an emergency access procedure and may make provisions for prepackaged drugs for emergency withdrawal, provided the number of doses does not exceed the number usually required by a patient during the time the pharmacy is closed.

Drugs prepackaged for emergency use, when a pharmacist is not available, shall be labeled with: I. identification of pharmacy. II. control number or date of issue. III. auxiliary labels as needed. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.7900 SubPart 3]. Drugs prepackaged for emergency use, when a pharmacist is not available, shall be labeled with: A. identification of pharmacy or other source; B. name of drug or list of ingredients; C. strength of drug or amount of ingredients; D. auxiliary labels as needed; E. expiration date, if any; F. usual dose; and G. control number or date of issue.

Intravenous admixtures must be labeled with: I. name of solution and volume of solution II. name and quantity of each additive III. bottle sequence number a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.7900 Subpart 5]. Intravenous admixtures must be labeled with the following information: A. name of solution and volume of solution; B. patient's name; C. bottle sequence number or other control number system, if appropriate; D. name and quantity of each additive; E. infusion or administration rate, if appropriate; F. storage requirements if other than room temperature; G. date and time of administration if appropriate; H. beyond-use date; and I. ancillary precautionary labels.

Each compounded immediate container of bulk radiopharmaceutical product must bear a label containing: I. Standard radiation symbol with words "Caution - Radioactive Material" II. Radiopharmaceutical name or its abbreviation III. Radiopharmaceutical lot number a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.8550 and 8700]. Immediate container of bulk radiopharmaceutical product: Each compounded container must bear a label containing the following information: A. standard radiation symbol with words "Caution - Radioactive Material"; B. radiopharmaceutical name or its abbreviation; and C. radiopharmaceutical lot number. Outer container of bulk radiopharmaceutical product: Each individual prepared dose must bear a label containing the following information: A. standard radiation symbol with words "Caution - Radioactive Material"; B. radiopharmaceutical name or its abbreviation; C. amount of radioactivity; D. calibration date and time; E. expiration date and time; F. volume - if liquid, weight - if solid, number of vials or ampoules - if gas, number of capsules - if capsules; G. added substances, such as stabilizers and preservatives; H. radiopharmaceutical lot number; I. name, address, and telephone number of nuclear pharmacy, if it is to be transferred for commercial distribution; and J. initials of preparing nuclear pharmacist, if it is to be transferred for commercial distribution. Outer container of each radiopharmaceutical dispensed: Each individual prepared dose must bear a label containing the: A. standard radiation symbol with words "Caution - Radioactive Material"; B. radiopharmaceutical name or its abbreviation; C. amount of radioactivity; D. calibration date and time; E. expiration date and time; F. volume - if liquid, or weight - if solid, and number of vials or ampoules - if gas; G. added substances, such as stabilizers and preservatives; H. radiopharmaceutical prescription or lot number; I. name, address, and telephone number of nuclear pharmacy; J. patient name; and K. initials of dispensing nuclear pharmacist. A pharmacist handling radiopharmaceuticals shall maintain records of acquisition and disposition of radiopharmaceuticals for at least two years.

Which of the following is/are TRUE about dispensing drugs by a licensed physician? I. The board may grant a license to any physician to dispense drugs to individuals for whom pharmaceutical care is not reasonably available. II. The physician shall apply for the limited service pharmacy permit to dispensed drugs. III. The physician may be assisted by a pharmacy technician if the technician holds a valid certification from the Pharmacy Technician Certification Board. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.19 Subdivision 4]. The board may grant a license to any physician to dispense drugs to individuals for whom pharmaceutical care is not reasonably available. Any physician licensed under this subdivision shall be limited to dispensing drugs in a limited service pharmacy and shall be governed by the rules adopted by the board when dispensing drugs. For the purposes of this subdivision, pharmaceutical care is not reasonably available if the limited service pharmacy in which the physician is dispensing drugs is located in a health professional shortage area, and no other licensed pharmacy is located within 15 miles of the limited service pharmacy. A physician granted a license under this subdivision may be assisted by a pharmacy technician if the technician holds a valid certification from the Pharmacy Technician Certification Board or from another national certification body for pharmacy technicians that require passage of a nationally recognized psychometrically valid certification examination for certification as determined by the board. The physician may supervise the pharmacy technician as long as the physician assumes responsibility for all functions performed by the technician. For purposes of this subdivision, supervision does not require the physician to be physically present if the physician or a licensed pharmacist is available, either electronically or by telephone.

For each drug repackaged by a contract pharmacy for residents of Long Term care Facility, the contract pharmacy shall maintain a record of which of the following? I. the name, manufacturer, manufacturer's lot number, manufacturer's expiration date, and quantity of the drug prescribed. II. the name and address or other identifier of the prescriber. III. the name and address of the resident for whom the drug was repackaged. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.415 Subdivision 4]. A contract pharmacy means a pharmacy which is under contract to a long-term care facility. An Original dispensing pharmacy shall mean a pharmacy, licensed in any state in the United States, which dispenses drugs in bulk prescription containers to a person who is a resident in a long-term care facility. For each drug repackaged by a contract pharmacy under this section, the contract pharmacy shall maintain a record for at least two years of the following information: (1). the name, manufacturer, manufacturer's lot number, manufacturer's expiration date, and quantity of the drug prescribed; (2). the name and address of the resident for whom the drug was repackaged; (3). the name and address or other identifier of the prescriber; (4). the date the prescription was issued and the date the drug was repackaged; (5). the date the repackaged drug was delivered to the long-term care facility; (6). the directions for use; (7). a copy of the label that was affixed to the repackaged drug; (8). the initials of the packager; (9). the initials of the supervising pharmacist; and (10). the name and business address of the original dispensing pharmacy.

Prescription Monitoring Program Advisory Task Force shall consist of: I. the Department of Human Services II. each health-related licensing board that licenses prescribers III. a professional pharmacy association a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.126 Subdivision 3]. The board has established an electronic system for reporting the information required for all controlled substances dispensed within the state. (a). The board shall convene an advisory committee. The committee must include at least one representative of: (1). the Department of Health; (2). the Department of Human Services; (3). each health-related licensing board that licenses prescribers; (4). a professional medical association, which may include an association of pain management and chemical dependency specialists; (5). a professional pharmacy association; (6). a professional nursing association; (7). a professional dental association; (8). a consumer privacy or security advocate; and (9). a consumer or patient rights organization. (10). an association of medical examiners and coroners. (b). The advisory task force shall advise the board on the development and operation of the prescription monitoring program, including, but not limited to: (1). technical standards for electronic prescription drug reporting; (2). proper analysis and interpretation of prescription monitoring data; (3). an evaluation process for the program; and (4). criteria for the unsolicited provision of prescription monitoring data by the board to prescribers and dispensers.

Each dispenser shall submit which of the following data to the board for controlled substances prescriptions? I. national provider identifier of the prescriber. II. number of days supply. III. national provider identifier of the dispenser. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.126 Subdivision 4]. (a). Each dispenser must submit the following data to the board or its designated vendor: (1). name of the prescriber; (2). national provider identifier of the prescriber; (3). name of the dispenser; (4). national provider identifier of the dispenser; (5). prescription number; (6). name of the patient for whom the prescription was written; (7). address of the patient for whom the prescription was written; (8). date of birth of the patient for whom the prescription was written; (9). date the prescription was written; (10). date the prescription was filled; (11). name and strength of the controlled substance; (12). quantity of controlled substance prescribed; (13). quantity of controlled substance dispensed; and (14). number of days supply.

The medical cannabis may be used for a patient suffering from: I. nausea or severe vomiting associated with cancer II. Tourette's syndrome III. glaucoma a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.22 Subd14]. "Medical cannabis product" means any delivery device or related supplies and educational materials used in the administration of medical cannabis for a patient with a qualifying medical condition enrolled in the registry program. Medical cannabis: (a) "Medical cannabis" means any species of the genus cannabis plant, or any mixture or preparation of them, including whole plant extracts and resins, and is delivered in the form of: (1). liquid, including, but not limited to, oil; (2). pill; (3). vaporized delivery method with use of liquid or oil but which does not require the use of dried leaves or plant form; or (4). any other method, excluding smoking, approved by the commissioner. Qualifying medical condition: "Qualifying medical condition" means a diagnosis of any of the following conditions: (1). cancer, if the underlying condition or treatment produces one or more of the following: (i). severe or chronic pain; (ii). nausea or severe vomiting; or (iii). cachexia or severe wasting; (2). glaucoma; (3). human immunodeficiency virus or acquired immune deficiency syndrome; (4). Tourette's syndrome; (5). amyotrophic lateral sclerosis; (6). seizures, including those characteristic of epilepsy; (7). severe and persistent muscle spasms, including those characteristic of multiple sclerosis; (8). inflammatory bowel disease, including Crohn's disease; (9). terminal illness, with a probable life expectancy of under one year, if the illness or its treatment produces one or more of the following: (i). severe or chronic pain; (ii). nausea or severe vomiting; or (iii). cachexia or severe wasting; or (10). any other medical condition or its treatment approved by the commissioner.

Which of the following information about an automated drug distribution system is/are TRUE? I. A pharmacy may use an automated drug distribution system to fill prescription drug orders for patients of a health care facility. II. Access to an automated drug distribution system must be limited to pharmacy and nonpharmacy personnel authorized to procure drugs from the system. III. At least 60 days prior to the initial use of an automated drug distribution system, the managing pharmacy must provide the board with written notification of the address at which the automated drug distribution system will be located, the manufacturer and model of the automated drug distribution system, and written policies and procedures that govern the operation of the system. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Pharmacy Act Chapter 151.58 and Minnesota Administrative Rules Chapter 6800 Sec.6800.2600 SubPart 3]. 1. A pharmacy may use an automated drug distribution system to fill prescription drug orders for patients of a health care facility. The automated drug distribution system may be located in a health care facility that is not at the same location as the managing pharmacy. 2. When located within a health care facility, the system is considered to be an extension of the managing pharmacy. 3. At least 60 days prior to the initial use of an automated drug distribution system, the managing pharmacy must provide the board with written notification of the address at which the automated drug distribution system will be located, the manufacturer and model of the automated drug distribution system, and written policies and procedures that govern the operation of the system. 4. The managing pharmacy and the pharmacist in charge are responsible for the operation of an automated drug distribution system. 5. Access to an automated drug distribution system must be limited to pharmacy and nonpharmacy personnel authorized to procure drugs from the system, or a licensed nurse within the health care facility. 6. Each person authorized to access the system must be assigned an individual specific access code. Alternatively, access to the system may be controlled through the use of biometric identification procedures.

A pharmacist may release a confidential report only to: I. the patient for whom the prescription was issued. II. the licensed practitioner who issued the prescription. III. a member, inspector, or investigator of the board. a. I only b. III only c. I and II only d. All

Answer: (d) All, [Minnesota Pharmacy Practice Act 151.213]. All prescriptions, drug orders, records or any other prescription information that specifically identifies an individual patient shall be held in the strictest confidence. No person in possession of such information shall release the information, unless requested as follows: (1). the patient for whom the prescription was issued, the patient's agent, or another pharmacist acting on behalf of the patient or the patient's agent; (2). the licensed practitioner who issued the prescription; (3). the licensed practitioner who is then treating the patient; (4). a member, inspector, or investigator of the board or any federal, state, county, or municipal officer whose duty it is to enforce the laws of this state or the United States relating to drugs and who is engaged in a specific investigation involving a designated person or drug; (5). an agency of government charged with the responsibility of providing medical care for the patient; (6). an insurance carrier or attorney on receipt of written authorization signed by the patient or the patient's legal representative, authorizing the release of such information; (7). any person duly authorized by a court order.

A pharmacist or practitioner shall NOT compound a drug product: I. if the drug product for compounding have been withdrawn or removed from the market. II. if the compounded finished drug product is essentially the copy of a commercially available drug product. III. if the compounded finished drug product has been identified pursuant to United States Code, as a drug product that presents demonstrable difficulties for compounding. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Pharmacy Practice Act 152.253 Subdivision 2]. A pharmacist or practitioner shall not: 1. compound a drug product that appears on a list published by the secretary of the federal Department of Health and Human Services in the Federal Register of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. 2. compound any drug products that are essentially copies of a commercially available drug product. 3. compound any drug product that has been identified pursuant to United States Code, title 21, section 353a, as a drug product that presents demonstrable difficulties for compounding.

Who may inspect pharmacy's controlled substance prescription record? I. an officer of the state II. an officer of the county III. an officer of the municipal government a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [Minnesota Pharmacy Practice Act Chapter 152 Section 152.11 Subdivision 1 (d)]. Every licensed pharmacy that dispenses a controlled substance prescription shall retain the original prescription in a file for a period of not less than two years, open to inspection by any officer of the state, county, or municipal government whose duty it is to aid and assist with the enforcement of Minnesota Pharmacy Law. An original electronic or facsimile prescription may be stored in an electronic database, provided that the database provides a means by which original prescriptions can be retrieved, as transmitted to the pharmacy, for a period of not less than two years.

Which of the following is/are TRUE about patient counseling? I. An offer to counsel shall be made to each patient or caregiver when the pharmacist fills, delivers or sends a new retail or outpatient prescription. II. A mail order pharmacy shall make the offer to counsel either by telephone or by sending a written offer together with the filled prescription. III. If the pharmacist, in the exercise of professional judgment in the interest of a patient, believes that an oral offer would be less effective than a written offer, the pharmacist may substitute a written offer. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [OBRA 90 and Minnesota Administrative Rules Chapter 6800 Sec.6800.0910 SubPart 2 (B)]. An offer to counsel shall be made to each patient or caregiver when the pharmacist fills, delivers or sends a new retail or outpatient prescription. The pharmacist or designee of the pharmacist shall orally make the offer in person if a patient or caregiver comes to the pharmacy. If the pharmacist, in the exercise of professional judgment in the interest of a patient, believes that an oral offer would be less effective than a written offer, the pharmacist may substitute a written offer. The following are examples of situations in which a pharmacist might substitute a written offer: (1). The patient or caregiver is hearing impaired. (2). The patient or caregiver is not an English speaker. If neither the patient nor caregiver comes to the pharmacy, the offer to counsel shall be made in one of the following ways: (1). The pharmacist or designee may telephone the patient or caregiver. (2). The pharmacy delivery person may orally make the offer to the patient or caregiver. (3). The pharmacist may send a written offer to counsel together with the filled prescription, which is delivered or sent to the patient. (4). A written offer to counsel shall include the telephone number of the pharmacy. (5). A pharmacy shall provide toll-free telephone service if its primary patient population is beyond the local or toll-free exchange. (6). A mail order pharmacy shall make the offer to counsel either by telephone or by sending a written offer together with the filled prescription. The written offer shall include a toll-free telephone number of the pharmacy which a patient or caregiver may use to obtain counseling.

Which of the following is/are TRUE ABOUT preparing allergen extracts as compounded sterile preparations? I. All allergen extracts as CSPs shall contain appropriate substances in effective concentrations to prevent the growth of microorganisms. II. Before beginning compounding activities, personnel perform a thorough hand-cleansing procedure by removing debris from under fingernails using a nail cleaner under running warm water followed by vigorous hand and arm washing to the elbows for at least 30 seconds with either non-antimicrobial or antimicrobial soap and water. III. Compounding personnel don hair covers, facial hair covers, gowns, and face masks. a. I only b. I and II only c. II and III only d. All

Answer: (d) All. Allergen extracts as CSPs are single-dose and multiple-dose intradermal or subcutaneous injections that are prepared by specially trained physicians and personnel under their direct supervision. Allergen extracts as CSPs are not subject to the personnel, environmental, and storage requirements for all CSP Microbial Contamination Risk Levels only when all of the following criteria are met: 1. The compounding process involves simple transfer via sterile needles and syringes of commercial sterile allergen products and appropriate sterile added substances (e.g., glycerin, phenol in sodium chloride injection). 2. All allergen extracts as CSPs shall contain appropriate substances in effective concentrations to prevent the growth of microorganisms. Non-preserved allergen extracts shall comply with the appropriate CSP risk level requirements under the USP chapter 797. 3. Before beginning compounding activities, personnel perform a thorough hand-cleansing procedure by removing debris from under fingernails using a nail cleaner under running warm water followed by vigorous hand and arm washing to the elbows for at least 30 seconds with either non-antimicrobial or antimicrobial soap and water. 4. Compounding personnel don hair covers, facial hair covers, gowns, and face masks. 5. Compounding personnel perform antiseptic hand cleansing with an alcohol-based surgical hand scrub with persistent activity. 6. Compounding personnel don powder-free sterile gloves that are compatible with sterile 70% isopropyl alcohol (IPA) before beginning compounding manipulations. 7. Compounding personnel disinfect their gloves intermittently with sterile 70% IPA when preparing multiple allergen extracts as CSPs. 8. Ampule necks and vial stoppers on packages of manufactured sterile ingredients are disinfected by careful wiping with sterile 70% IPA swabs to ensure that the critical sites are wet for at least 10 seconds and allowed to dry before they are used to compound allergen extracts as CSPs. 9. The aseptic compounding manipulations minimize direct contact contamination (e.g., from glove fingertips, blood, nasal and oral secretions, shed skin and cosmetics, other nonsterile materials) of critical sites (e.g., needles, opened ampules, vial stoppers). 10. The label of each multiple-dose vial (MDV) of allergen extracts as CSPs lists the name of one specific patient and a BUD and storage temperature range that is assigned based on manufacturers' recommendations or peer-reviewed publications. 11. Single-dose allergen extracts as CSPs shall not be stored for subsequent additional use.

Compounding includes which of the following? a. Preparation of drug dosage forms for both human and animal patients b. Reconstitution or manipulation of commercial products ingredients c. Preparation of drugs and devices for prescriber's office use where permitted by federal and state law. d. Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or academic), teaching, or chemical analysis. a. a, b and d b. c and d c. a and c d. All

Answer: (d) All. The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following: 1. Preparation of drug dosage forms for both human and animal patients. 2. Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. 3. Reconstitution or manipulation of commercial products ingredients. 4. Preparation of drugs and devices for prescriber's office use where permitted by federal and state law. 5. Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or academic), teaching, or chemical analysis.

Under Minnesota State Pharmacy Law, any adverse healthcare-related event shall be forwarded to the: a. Governor b. Secretary of Board c. Senator of county d. Commissioner of health

Answer: (d) Commissioner of health, [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.301(a),(b)]. The Board shall maintain a record of an event that comes to the Board's attention that, in the judgment of the Board or a committee of the Board, qualifies as an adverse health care event. Within 30 days of making a determination that an event qualifies as an adverse health care event, the Board shall forward to the commissioner of health a report of the event, including: 1. the facility involved, 2. the date of the event, and 3. information known to the Board regarding the event. The report shall NOT include any identifying information for any of the health care professionals, facility employees, or patients involved.

Using the NARxCHECK, a pharmacist is receiving the scaled score of 650 for a particular patient. Which of the following statements based on this scaled score is TRUE? a. Very low risk for misuse. b. Low risk for misuse. c. Moderate risk for misuse. d. High risk for misuse.

Answer: (d) High risk for misuse, [https://www.nabp.net]. NARXCHECK is an automatic prescription drug abuse assessment and management tool for health care providers. Once integrated into the facility's system, NARxCHECK automatically queries the state PMP database to generate a report that includes a score for three different drug classes: narcotics, sedatives, and stimulants. These three-digit scores (000-999) help practitioners to decide whether or not they need to review a patient history before prescribing additional medications. The score is easy to read using the following guidelines: 1. Less than 200 = Be confident - low risk for misuse. 2. 200 - 500 = Be curious - moderate risk for misuse. 3. Greater than 500 = Be cautious - higher risk for misuse.

To be a qualified nuclear pharmacist in Minnesota, the pharmacist shall: I. be currently licensed pharmacist in Minnesota and be certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties. II. have received a minimum of 200 contact hours of instruction in nuclear pharmacy and the safe handling and use of radioactive materials from an accredited college of pharmacy. III. attain a minimum of 500 hours of clinical nuclear pharmacy training under the supervision of a qualified nuclear pharmacist. a. I and II only b. I and III only c. II and III only d. I or II and III only

Answer: (d) I or II and III only [Minnesota Administrative Rules Chapter 6800 Sec.6800.8500]. A qualified nuclear pharmacist shall be a currently licensed pharmacist in Minnesota and either be certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties OR Meet the following standards: A. have received a minimum of 200 contact hours of instruction in nuclear pharmacy and the safe handling and use of radioactive materials from an accredited college of pharmacy, with emphasis in the following areas: (1) radiation physics and instrumentation; (2) radiation protection; (3) mathematics of radioactivity; (4) radiation biology; and (5) radiopharmaceutical chemistry; B. attain a minimum of 500 hours of clinical nuclear pharmacy training under the supervision of a qualified nuclear pharmacist; and C. submit an affidavit of experience and training to the Board of Pharmacy.

Which of the following contains codes for diseases, signs and symptoms and abnormal findings? a. NAREx b. Red Book c. Purple Book d. ICD-10

Answer: (d) ICD-10. ICD-10 is the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD), a medical classification list by the World Health Organization (WHO). It contains codes for diseases, signs and symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases. Work on ICD-10 began in 1983, in 1990 it was endorsed by the Forty-third World Health Assembly and was first used by member states in 1994. The code set in the base classification allows for more than 14,400 different codes and permits the tracking of many new diagnoses compared to ICD-9. Through the use of optional sub-classifications, the number of codes can be expanded to over 16,000. Some national editions expand the code set even further; ICD-10-CM, for example, has over 70,000 codes. The WHO provides detailed information about ICD online, and makes available a set of materials online, such as an ICD-10 online browser, ICD-10 Training, ICD-10 online training, ICD-10 online training support and study guide materials for download. The International version of ICD is the base classification for the national modifications of ICD. The adapted versions may differ in a number of ways.

A pharmacist is dispensing brand name Lopressor (Mfg: Pfizer). Which of the following shall be placed on the dispensing label? a. Metoprolol, (Mylan) b. Lopressor c. Metoprolol, (a generic for Lopressor) d. Lopressor (Pfizer)

Answer: (d) Lopressor (Pfizer), [Minnesota Board of Pharmacy Statues Chapter 151 Sec.151.212 Subdivision 1]. Drugs dispensed pursuant to a prescription shall bear a label permanently affixed to the immediate container in which the drug is dispensed and which is received by the purchaser. The label shall bear the name of the manufacturer or distributor of the finished dosage form of the drug and all other information required by law and by rules of the board.

It is unlawful for any manufacturer or wholesale drug distributor, or any agent thereof, to offer or give any gift of value to a practitioner. Which of the following shall be considered as a gift to the practitioner? I. the payment for the reasonable expenses to a practitioner who serves on the faculty at a professional or educational conference or meeting. II. items with a total combined retail value, in any calendar year, of not more than $50. III. professional samples of a drug provided to a prescriber for free distribution to his/her patients. a. I only b. I and II only c. All d. None of the above

Answer: (d) None of the above qualified as gifts, [Minnesota Pharmacy Act Chapter 151.461]. It is unlawful for any manufacturer or wholesale drug distributor, or any agent thereof, to offer or give any gift of value to a practitioner. A medical device manufacturer that distributes drugs as an incidental part of its device business shall not be considered a manufacturer, a wholesale drug distributor, or agent under this section. As used in this section, "gift" does NOT include: (1). professional samples of a drug provided to a prescriber for free distribution to patients; (2). items with a total combined retail value, in any calendar year, of not more than $50; (3). a payment to sponsor a medical conference, professional meeting, or other educational program, provided the payment is NOT made DIRECTLY to a practitioner and is used solely for bona fide educational purposes; (4). the payment for the reasonable expenses to a practitioner who serves on the faculty at a professional or educational conference or meeting; (5). compensation for the substantial professional or consulting services of a practitioner in connection with a genuine research project; (6). publications and educational materials; or (7). salaries or other benefits paid to employees.

A prescriber wishes to purchase acetaminophen with codeine 30 mg for "office use". Which of the following statements is TRUE? a. The prescriber must write a prescription labeling "Office Use Only". b. The prescriber must write a prescription for himself. c. The prescriber must complete a DEA Form 222. d. The prescriber shall order it directly from a supplier.

Answer: (d) The prescriber shall order it directly from a supplier, [21CFR1306.04(b)]. A prescription may not be issued in order for an individual practitioner to obtain a supply of controlled substances for the purpose of general dispensing to his/her patients. Therefore, a prescription written for office stock or "medical bag" use is not valid.

The pharmacist receives a telephone prescription for Alprazolam from a physician's assistant. Assuming that the dosage, quantity, and instructions are appropriate, and the prescription is reduced to writing, the pharmacist should: a. Not fill the prescription because a triplicate prescription is required. b. Not fill the prescription because a telephone prescription for Alprazolam is not valid. c. Fill the telephone prescription if the physician confirms all information with the pharmacist. d. It cannot be said since a prescriptive authority for controlled substances for a physician's assistant may vary a state to state.

Answer: (d) Under Federal Pharmacy Law and Controlled Substances Act, a prescriptive authority by mid-level practitioners is not well defined. For example, according to section 1306.03 (CFR): Persons entitled to issue prescriptions: _________________________________ (a). A prescription for a controlled substance may be issued only by an individual practitioner who is: (1). Authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and (2). Either registered or exempted from registration pursuant to 1301.22(c) and 1301.23 of this chapter. (b). A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner. Under Section 1300.01 (definition 28): The term mid-level practitioner means an individual practitioner, other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants who are authorized to dispense controlled substances by the state in which they practice. Therefore, the prescriptive authority of mid-level practitioners is completely depending on states in which they practice.

A pharmacy technician may perform all of the following duties EXCEPT: a. initiating and receiving refill authorization requests. b. entering prescription data into a data processing system. c. taking a stock bottle from the shelf for a prescription. d. taking a new oral order from a prescriber.

Answer: (d) taking a new oral order from a prescriber, [Minnesota Administrative Rules Chapter 6800 Sec.6800.3850 Subpart 2]. Pharmacy technicians may perform only nonjudgmental technical duties associated with the preparation and distribution of prescription drugs, including but not limited to the following: (1). initiating and receiving refill authorization requests; (2). entering prescription data into a data processing system; (3). taking a stock bottle from the shelf for a prescription; (4). preparing and packaging prescription drug orders (i.e. counting tablets/capsules, measuring liquids and placing them in the prescription container); (5). affixing prescription labels and auxiliary labels to the prescription container provided by the pharmacy technician: (6). reconstituting medications; (7). prepackaging and labeling prepackaged drugs; (8). loading bulk unlabeled drugs into an automated dispensing system provided a pharmacist verifies that the system is properly loaded prior to use; (9). compounding non-sterile prescription drug orders; and (10). bulk compounding.

A physician requesting Oxycodone for relieving a pain to treat one of hospitalized patients. A hospital pharmacy is currently out of stock of the requested drug. He asks a hospital pharmacist to borrow Oxycodone from another hospital. Which of the following is the most appropriate? a. The hospital pharmacist should borrow the requested medication from another hospital. b. The hospital pharmacist should tell the requesting physician that a schedule II-controlled substance can only be obtained from a wholesale distributor. c. The hospital pharmacist should suggest another pain reliever to the requesting physician. d. The hospital pharmacist should get Oxycodone from another hospital by executing a DEA 222 order form.

Answer: (d), [21CFR1305.03]. The hospital pharmacist should get Oxycodone from another hospital by using a DEA 222 order form. A DEA Form 222 is required for each distribution/transfer of a Schedule I or II controlled substance.

In Minnesota, a business establishment that offers for sale methamphetamine precursor drugs in an over-the-counter sale shall ensure that all packages of the drugs are offered for sale only by a: I: Pharmacist II: Pharmacy Tech III: Pharmacy clerk a. I only b. I and II only c. II and III only d. All

Answer:(d) All, [Minnesota Board of Pharmacy Statues Chapter 152 Sec.152.02 Subdivision 6(e)]. A business establishment that offers for sale methamphetamine precursor drugs in an over-the-counter sale shall ensure that all packages of the drugs are displayed behind a checkout counter where the public is not permitted and are offered for sale only by a licensed pharmacist, a registered pharmacy technician, or a pharmacy clerk. The establishment shall ensure that the person making the sale requires the buyer: (1). to provide photographic identification showing the buyer's date of birth; and (2). to sign a written or electronic document detailing the date of the sale, the name of the buyer, and the amount of the drug sold.