Federal Test pharmacy exam

Which act exempts certain devices from premarket notification requirements?

Food and Drug Modernization Act of 1997

Do dietary supplements need to conform to good manufacturing practice?

Yes. Only recently

When filling a prescription for Tylenol no. 3, the pharmacist may assign the maximum number of available refills: A. 5 times B. 10 times C. As needed D. 0 times

A. 5 times No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued. No prescription for a controlled substance listed in Schedule III or IV authorized to be refilled may be refilled more than five times. Tylenol No. 3 (Acetaminophen and Codeine) is classified as a schedule III controlled drug, and cannot be filled more than five times within a six-month period.

U.S. Health Coalition message: "Double Check, Don't Double Up" is in reference to which of the following? A. Acetaminophen B. Digoxin C. Levothyroxine D. Oxycodone

A. Acetaminophen

A prescription for Vicodin can be refilled how many times?

A. Cannot be refilled

DEA form 224a should be used for: A. Renewal of registration for dispensing controlled substances. B. New registration for dispensing controlled substances. C. Reporting theft or loss of controlled substances. D. None of the above.

Answer: (a) A DEA 224a form should be used for renewal of registration for dispensing controlled substances, 1. DEA 222: For purchase and transfer of Schedule I and II controlled substances. 2. DEA 224: New registration for Dispensing. 3. DEA 224A: Renewal of registration for Dispensing. 4. DEA 225: New registration for Manufacturing, Distributing, Reverse Distributing, Importing, Exporting, Chemical Analysis or Research. 5. DEA 225A: Renewal of registration for Manufacturing, Distributing, Reverse Distributing, Importing, Exporting, Chemical Analysis or Research. 6. DEA 363: New registration for Narcotic Treatment Program. 7. DEA 363A: Renewal of registration for Narcotic Treatment Program. 8. DEA 106: For reporting theft or loss of controlled substances. 9. DEA 41: For disposal or destruction of controlled substances.

All of the following are classified as controlled II barbiturates EXCEPT: a. Phenobarbital b. Amobarbital c. Secobarbital d. Pentobarbital

Answer: (a) Phenobarbital is classified as a Schedule IV controlled drug, [21CFR1308.14]. The other barbiturates such as Amobarbital, Secobarbital and Pentobarbital are classified as Schedule II controlled substances, [21CFR1308.12].

Which of the following copies of a DEA 222 order form must the purchaser keep for his own record? I. Copy 3 II. Copy 2 III. Copy 1 a. I only b. I and II only c. II and III only d. All

Answer: (a) The purchaser must fill out all three copies of the DEA 222 form, [21CFR1305.13(d)]. He submits copies I and II of the DEA 222 form to the supplier and keeps copy III for his own record. The supplier records on the first and second copies the number of containers furnished on each item and the date on the containers that were shipped. The supplier keeps copy 1 for his own record and forwards copy 2 to the DEA.

CSOS Certificates expire when the DEA Registration to which they are associated expires. a. True b. False

Answer: (a) True, [http://www.deaecom.gov/qanda.html]. CSOS Certificates expire when the DEA Registration to which they are associated expires. The CSOS RA will send an email notifying the Subscriber's CSOS Coordinator 45 days prior to the expiration date of the Subscriber's CSOS certificate and will provide instructions on how to process digital certificate renewals.

When should a pharmacist offer patient counseling? I. Upon a new prescription drug order. II. Upon refill of a prescription drug order. III. Once yearly on maintenance drugs. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. A pharmacist should offer patient counseling on new prescription drug orders, refill orders and once yearly on maintenance drugs (maintenance medications are defined as any medication the patient has taken for one year or longer).

Which of the following drugs is/are classified under the Pregnancy Category X? I. Cytotec II. Accutane III. Pravachol a. I only b. I and II only c. II and III only d. All

Answer: (d) The following drugs are classified under the Pregnancy Category-X. 1. Isotretinoin (Accutane) 2. HMG-COA inhibitors (e.g. Pravachol) 3. Misoprostol (Cytotec) 4. Finasteride (Proscar, Propecia) 5. Warfarin (Coumadin) 6. Alcohol

A Walgreen Pharmacy must renew its DEA registration to dispense controlled drugs every: a. 1 year b. 3 years c. 9 months d. 2 years

Answer: (b) Every pharmacy engaged in the dispensing of controlled substances must register with the DEA. The registration should be kept in the pharmacy, available for inspection. The registration must be renewed every three years, [21CFR1301.13(d)]. If the person/company owns more than one pharmacy, each pharmacy must be separately registered, [21CFR1301.12(a)].

The statement, "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed", is required when dispensing: I. Schedule II controlled drugs. II. Schedule III controlled drugs. III. Schedule V controlled drugs. a. I only b. I and II only c. II and III only d. All

Answer: (b) Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed is required when dispensing Schedule II, III and IV controlled drugs.

A pharmacist who is reconstituting the Amoxicillin Suspension adds 75cc of distilled water to reconstitute the suspension. However, the label instruction on Amoxicillin bottle suggests to add 125cc. The resultant compounding shall be classified as: a. Adulterated b. Misbranded

Answer: (b) Misbranded, [(U.S.C.) Title 21, Chapter 9, Subchapter V, 502,352].

Which of the following statements defines "Reverse Distributions"?

Answer: (c) "Reverse distribution" means the receipt of prescription drugs including controlled substances for the purposes of destroying the drugs or returning the drugs to their original manufacturers or distributors.

Which of the following requires a PPI when dispensed? I. Accutane II. Lo-Ovral III. Premarin a. I only b. I and II only c. II and III only d. All

Answer: (d) A PPI (Patient Package Insert) is generally required when dispensing the following drugs [21CFR310, 501,515]: 1. Isotretinoin 2. Estrogen and progesterone containing products 3. Oral contraceptives

Which of the following should be part of Drug Utilization Review? I. Drug-drug interaction. II. Duplication of therapy. III. Direction for use. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. A Drug Utilization Review may include: ________________________________ 1. known allergies. 2. rational therapy-contraindication. 3. reasonable dose, direction for use and route of administration. 4. duplication of therapy. 5. drug-drug, drug-food and drug-disease interactions. 6. adverse drug reactions. 7. overutilization or underutilization of prescribed drugs.

Which of the following is/are found in the PPI? I. Indication and usage. II. Adverse reactions and contraindications. III. Dosage and administration information. a. I only b. I and II only c. II and III only d. All

Answer: (d) All. The PPI (Patient Package Insert) normally contains the following: a. Indications and usage of medication b. Pharmacodynamic and pharmacokinetic information c. Contraindication and adverse reactions d. Drug interaction e. Dosage and its administration information

Do pharmacies need to register with the FDA? Any conditions to do so?

No if they are following: Local laws AND Regularly engaged in dispensing RX drugs and devices, upon RX of practitioners

Do legend drugs have to contain the same labeling of OTC?

No. The drug cannot be made safe by simply adding a warning or directions for use to the label

Category X pregnancy warning

Studies in animals OR reports in pregnant women indicate clear risk outweighs any benefit to pregnant woman

A nursing home which provides extended health care to patients is classified as: A. HMO B. HCFA C. FTC D. LTCF

(d) Long Term Care Facility (LTCF) LTCF means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients, [21CFR1300.01 Definitions]. A Skilled Nursing Facility is a nursing home that meets criteria for accreditation established by the sections of the Social Security Act that determine the basis for Medicaid and Medicare reimbursement for skilled nursing care. Skilled nursing care includes rehabilitation and various medical and nursing procedures. An Intermediate Care Facility (ICF) is a nursing home that is recognized only under Medicaid.

Durham-Humphrey Amendment of 1951 Definition (3)

- Distinguish between RX and OTC -RX drugs cneeded to contain a warning that drugs legally needed to be authorized by a HC professional in order to be dispensed -Prohibits unauthorized refills

What products are excluded from tamper resistant packaging? (4)

-Dermatological -Dental products -Insulin -Lozenge products

If a salicylate product is clearly labeled for adults, what does it not need to say?

-For children less than 3 years old, please consult your physician Does NOT need to be included

What is included in a package insert for an estrogen product? (8)

-Name of drug -Name/address of manufacturer -Statement defining the benefits and proper uses of estrogens -Contraindications to use -Description of most serious ADE -Summary of other side effects -How to reduce risks of estrogen use -Date of most recent revision of the PI

Category B pregnancy warning (2)

-No adequate, controlled studies in PREGNANT women -Animal studies have failed to demonstrate risk to fetus

Category D pregnancy warning (2)

-Positive evidence for risk to HUMAN fetus based on marketing experience -Give ONLY if benefits may be acceptable, despite risks

Kefauver-Harris Amendment of 1962 (What sparked it and definition (7)

-Thalidomide scare in Europe -Requires EFFICACY before marketing -Reinforced safety -Report ADE to the FDA -Advertisements disclose risk and benefit of products -Informed consent from participants in clinical trials -NDA needed -CGMP added

USP 797 is followed by what type of compounding?

503A sterile compounding pharmacies

Which of the following is/are classified Schedule IV controlled drug(s)? I. Xanax II. Ambien III. Ultram

All

A controlled substance listed in Schedules II which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail. a. True b. False

Answer: (a) True, [21 CFR Section 1306.26]. A controlled substance listed in Schedules II, III, IV, or V which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail.

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.

Under the Controlled Substances Act (CSA), what changes may a pharmacist make to a prescription written for a controlled substance in schedules III-V? I. The dosage form of the prescribed controlled substance II. The strength of the prescribed controlled substance III. The quantity of the prescribed controlled substance a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [http://www.deadiversion.usdoj.gov/faq/general.htm]. The pharmacist may add or change the patient's address upon verification. The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to controlled substance prescriptions. The pharmacist is never permitted to make changes to the patient's name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescriber's signature.

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 order from a prescriber.

Answer: (d) 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.

What 2 kind of products require a package insert?

Estrogen products Oral contraceptives

When do you need to provide a package insert?(2)

First fill -Every 30 days that therapy continues (EVERY REFILL)

What act prohibited misbranding and adulterating products

Food and Drug Act of 1906

What does good manufacturing practices refer to? (3)

Manufacturing Processing Packaging

Class I recall

Reasonable probability the use/exposure will cause serious ADE or DEATH

What is the FDA responsible for?

Regulation of MANUFACTURING and distribution

What is compounding under 503A ? What are you exempt from (3)? Definition?

Traditional Compounding - Exempt from NDA, GMP, labeling requirements Patient specific RX required

When looking at misbranding, what are examples of wrong labeling (5)

-Actual label -Package insert (missing/wrong PPI) -Drug advertisements -Information in publication such as PDR -Promotional materials

Category A pregnancy warning (2)

-Adequate well controlled studies -No risk to fetus during any trimester

Examples of tamper-resistant packaging (6)

-Blister packs -Film wrappers (Transparent film wrapped securely around the entire product container) -Aerosol containers (Inherently tamper resistant because of their design) -Tape seals -Break away caps -Foil paper or plastic pouch that must be torn -

Dietary Supplement Health and Education Act of 1994 (3)

-Defined vitamins, herbs, and minerals to be exempt from food additive provisions -FDA must prove supplements are unsafe -Allowed nutritional support statements

Nutrition Labeling and Education Act of 1990 (2)

-FDA approved health claims on FOOD labels and required a uniform format (serving size, contents, calories, nutrients) -Dietary supplement manufacturers can make health claims WITHOUT being considered drugs

Food and Drug Modernization Act of 1997 (3)

-Fast-track approval for certain new drugs and -Exempted certain devices from premarket notification requirements -Talks about compounding, but not enforced by FDA because of the ambiguity behind it

Definition of adulterated examples (7)

-Filthy, putrid, or decomposed substance -Filled/packaged under unsanitary conditions -NOT IN COMPLIANCE WITH GCMP -Poisonous product contained -Unsafe color additive -Any substance mixed with drug to reduce drug's strength -Drug strength, quality, or purity is different than what is listed on the label

What must be on the label of a salicylate containing product? (5)

-Keep out of reach of children -In case of overdose, get medical help/Contact Poison Control -For children under 3 years old, consult your physician -Reye's Syndrome: Children and teens who have/recovering from chicken pox of flu like symptoms should NOT use -If child has N/V when using this, contact MD. Could be early signs of Reye's

Examples of misbranding (7)

-Labeling on a bottle is false or misleading (VERY BROAD) -Packaging does NOT list the name/address of manufacturer -Does not list that an ingredient is habit forming -Does NOT have adequate directions for use (unless an RX, then it is exempt) -Dispensing WITHOUT an RX -Dispensing WITHOUT an authorized refill -A misfill

What is included in an oral contraceptive package insert? (10)

-Name of drug -List effectiveness of oral contraceptives vs. other methods -List effectiveness of OC to prevent pregnancy -Contraindications to use -BBW to show increased risks with cigarette smoking -How to use, ADE -Statement to describe risk to unborn child and mother if taken during pregnancy -Benefits of OC -Name/address of manufacturer -Date of last revision of PI

Category C pregnancy warning (3)

-Safety during pregnancy has NOT been established -Animal studies are POSITIVE for fetal risk or have NOT been conducted -Determine benefit/risks

What is the max dose in a salicylate tablet? What is the max amt. of tablets in a package? Why?

1 and 1/4 grains (~81mg) Max 36 tablets in a box To reduce hazard in overdose

NDC (What does each set of numbers mean)

10 or 11 digits long First 4 or 5 (Manufacturer) Middle 4 (ID of Drug Name, Strength, Dosage Form) Last 2 (Package Size)

Which of the following is required to order Schedule I and II controlled drugs? A. DEA 222 B. DEA 106 C. DEA 41 D. DEA 351

A. DEA 222 Answer: (a) Schedule I and II controlled drugs can be ordered by filling out a DEA 222 form, [21CFR1305.13]. (a). A purchaser must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier. The copy retained by the purchaser may be in paper or electronic form. (b). A supplier may fill the order, if possible and if the supplier desires to do so, and must record on the original DEA Form 222 its DEA registration number and the number of commercial or bulk containers furnished on each item and the date on which the containers are shipped to the purchaser. If an order cannot be filled in its entirety, it may be filled in part and the balance supplied by additional shipments within 60 days following the date of the DEA Form 222. No DEA Form 222 is valid more than 60 days after its execution by the purchaser, except as specified in paragraph (f) of this section. (c). The controlled substances must be shipped only to the purchaser and the location printed by the Administration on the DEA Form 222, except as specified in paragraph (f) of this section. (d). The supplier must retain the original DEA Form 222 for the supplier's files in accordance with §1305.17(c). Any supplier who is not required to report acquisition/disposition transactions to the Automation of Reports and Consolidated Orders System (ARCOS) under §1304.33(c) (such as a practitioner) must make and submit a copy of the original DEA Form 222 to DEA, either by mail to the Registration Section, or by email to [email protected]. The copy must be forwarded at the close of the month during which the order is filled. If an order is filled by partial shipments, the copy must be forwarded at the close of the month during which the final shipment is made or the 60-day validity period expires. (e). The purchaser must record on its copy of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser. (f). DEA Forms 222 submitted by registered procurement officers of the Defense Supply Center of the Defense Logistics Agency for delivery to armed services establishments within the United States may be shipped to locations other than the location printed on the DEA Form 222, and in partial shipments at different times not to exceed six months from the date of the order, as designated by the procurement officer when submitting the order.

The address printed on DEA 222 order forms for Rite Care Pharmacy is incorrect. In that case the Registrant: A. must return the form to the DEA to correct the error. B. should rewrite the correct address before ordering the drug. C. should not worry about the address. D. should place the correct address label before ordering the drug.

A. must return the form to the DEA to correct the error (a). DEA Forms 222 are issued in mailing envelopes containing a predetermined number of forms based on the business activity of the registrant, each form consisting of one single-sheet. A limit, which is based on the business activity of the registrant, will be imposed on the number of DEA Forms 222 that will be furnished upon a requisition for order forms unless additional forms are specifically requested and a reasonable need for such additional forms is shown. (b). Any person with an active registration that is authorized to order schedule I and II controlled substances is entitled to obtain a DEA Form 222, which will be supplied at any time after the DEA registration is granted. Any person holding a registration authorizing the person to obtain a DEA Form 222 may requisition the forms through a DEA secured network connection or by contacting any Division Office or the Registration Section of the Administration through the customer service center. (c). Each requisition must show the name, address, and registration number of the registrant and the number of DEA Forms 222 desired. (d). DEA Forms 222 will have an order form number and be issued with the name, address and registration number of the registrant, the authorized activity, and schedules of the registrant. This information cannot be altered or changed by the registrant; the registrant must report any errors to the local Division Office or the Registration Section of the Administration to modify the registration.

The dispensing container shall bear a label with all of the following EXCEPT: a. name, address and phone number of the manufacturer. b. unique identification number of the prescription. c. name of the prescribing practitioner. d. initials or an identification code of the dispensing pharmacist.

Answer: (a) At the time of delivery of the drug, the dispensing container shall bear a label with at least the following information, [21CFR1306.14 and 21CFR1306.24]: (1). name, address and phone number of the pharmacy (not the manufacturer); (2). unique identification number of the prescription; (3). date the prescription is dispensed; (4). initials or an identification code of the dispensing pharmacist; (5). name of the prescribing practitioner; (6). name of the patient or if such drug was prescribed for an animal, the species of the animal and the name of the owner; (7). instructions for use; (8). quantity dispensed; (9). appropriate ancillary instructions such as storage instructions or cautionary statements such as warnings of potential harmful effects of combining the drug product with any product containing alcohol; (10). if the prescription is for a Schedule II - IV controlled substance, the statement "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"; (11). if the pharmacist has selected a generically equivalent drug pursuant to the provisions of the Act, the statement "Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where "Brand Name" is the actual name of the brand name product prescribed; (12). the name of the advanced practice nurse or physician assistant, if the prescription is carried out or signed by an advanced practice nurse or physician assistant in compliance; (13). the name and strength of the actual drug product dispensed, unless otherwise directed by the prescribing practitioner.

The first five digits of NDC generally identify the: a. Manufacturer b. Drug c. Dosage form d. Package size

Answer: (a) Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for human drugs. It generally consists of ten digits. 1. The first segment, the labeler code, is 4 or 5 digits long and assigned by the Food and Drug Administration (FDA) upon submission of a Labeler Code Request. A labeler is any firm that manufactures, repacks or distributes a drug product. 2. The second segment, the product code, is 3 or 4 digits long and identifies a specific strength, dosage form, and formulation for a particular firm. 3. The third segment, the package code, is 1 or 2 digits long and identifies package forms and sizes. In very exceptional cases, product and package segments may have contained characters other than digits. NDC codes exist in one of the following groupings of digits into segments: 4-4-2, 5-3-2, or 5-4-1, but all NDC codes have 10 digits. The official FDA format for NDCs separates the 3 segments with dashes. This is the format in which the NDC must be submitted by labelers since mandatory electronic listing was established in June 2009. The Centers for Medicare and Medicaid Services (CMS) had created an 11-digit NDC derivative, which pads the labeler, product, or package code segments of the NDC with leading zeroes wherever they are needed to result in a fixed length 5-4-2 configuration (but always written without dashes). This format was adopted by data standards selected pursuant to HIPAA regulation, thus other government agencies' lists and databases may contain the 11-digit derivative of the original NDC.

Which of the following is/are NOT TRUE about dispensing Schedule V OTC controlled drugs? I. The purchaser at retail is at least 21 years of age. II. Dispensing should be done only by a registered pharmacist. III. A record of dispensing must be entered to the Schedule V bound book. a. I only b. I and II only c. II and III only d. All

Answer: (a) I is not true, [21CFR1306.26(a)-to-(e)]. The dispensing of Schedule V OTC controlled substances should be done only by a registered pharmacist. The purchaser at retail should be at least 18 years of age. A record of dispensing must be entered to the Schedule V bound book. No more than 240 cc or 48 dosage units of any controlled substance that contains opium, or more than 120 cc or 24 dosage units of any other controlled substance, may be dispensed at retail to the same purchaser in any given 48-hour period. The pharmacist must maintain a bound record book with the following information: 1. Name and address of he purchaser. 2. Name and quantity of the controlled substance. 3. Date of the purchase. 4. Initial of the dispensing pharmacist.

After dispensing a Schedule II drug based on oral authorization of a prescribing individual practitioner, the pharmacist shall contact which of the following upon not receiving a written prescription from the prescriber within 7 days? I. Nearest DEA Office II. Patient III. State Board of Pharmacy a. I only b. I and II only c. II and III only d. All

Answer: (a) Nearest DEA office, [21CFR1306.11(d)(4)]. Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. The paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7-day period. The pharmacist must notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.

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).

A type of drug recall in which there is a reasonable probability that the use of or exposure to a marketed product will cause serious adverse health consequences or death is known as: a. Class I recall b. Class II recall c. Class III recall d. Class IV recall

Answer: (a) Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. The severity of recall depends upon the adverse effect exhibited by the drug. Based on severity, drug recall are classified into three categories. Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. a. True b. False

Answer: (a) True, [21CFR1301.76(b)]. The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. (a). The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause. (b). The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft. When determining whether a loss is significant, a registrant should consider, among others, the following factors: (1). The actual quantity of controlled substances lost in relation to the type of business; (2). The specific controlled substances lost; (3). Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances; (4). A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known, (5). Whether the specific controlled substances are likely candidates for diversion; (6). Local trends and other indicators of the diversion potential of the missing controlled substance.

A registered retail pharmacy that possesses additional registrations for automated dispensing systems at long term care facilities may keep all records required for those additional registered sites at the retail pharmacy or other approved central location. a. True b. False

Answer: (a) True, [21CFR1304.04(a)(2),(b)]. (2). A registered retail pharmacy that possesses additional registrations for automated dispensing systems at long term care facilities may keep all records required by this part for those additional registered sites at the retail pharmacy or other approved central location. (b). All registrants that are authorized to maintain a central recordkeeping system shall be subject to the following conditions: (1). The records to be maintained at the central record location shall not include executed order forms and inventories, which shall be maintained at each registered location. (2). If the records are kept on microfilm, computer media or in any form requiring special equipment to render the records easily readable, the registrant shall provide access to such equipment with the records. If any code system is used (other than pricing information), a key to the code shall be provided to make the records understandable. (3). The registrant agrees to deliver all or any part of such records to the registered location within two business days upon receipt of a written request from the Administration for such records, and if the Administration chooses to do so in lieu of requiring delivery of such records to the registered location, to allow authorized employees of the Administration to inspect such records at the central location upon request by such employees without a warrant of any kind. (4). In the event that a registrant fails to comply with these conditions, the Special Agent in Charge may cancel such central recordkeeping authorization, and all other central recordkeeping authorizations held by the registrant without a hearing or other procedures. In the event of a cancellation of central recordkeeping authorizations under this paragraph the registrant shall, within the time specified by the Special Agent in Charge, comply with the requirements of this section that all records be kept at the registered location.

A pharmacy must register as a distributor if it distributes more than: a. 2 % of all controlled substances to another registrant within 1 year. b. 5 % of all controlled substances to another registrant within 1 year. c. 3 % of all controlled substances to another registrant within 1 year. d. 4 % of all controlled substances to another registrant within 1 year.

Answer: (b) A pharmacy must register as a distributor if it distributes more than 5 % of all controlled substances to another registrant within 1 year period [21CFR1307.11(a)(1),(2),(3),(4)]. A pharmacy registered to dispense controlled substances may distribute controlled substances even without being registered as a distributor provided that: I. The pharmacy or physician to which the controlled substance is distributed must be registered under the Act to dispense controlled substances. II. The distributing pharmacy must keep accurate record of distributing controlled substances including name, dosage form and quantity of the controlled substance distributed. It also requires the name, address and DEA registration number of the receiving pharmacy or physician. III. If the transferred controlled substance is either a Schedule I or II controlled drug, the transfer must be made on a DEA 222 order form. IV. The total number of controlled substances distributed by the pharmacy to another registrant must not exceed 5 % of all controlled substances dispensed by the pharmacy within a 12-month period.

The CSOS digital certificate holder must report the loss, theft, or compromise of the private key or the password, via a revocation request, to the DEA Certification Authority within 7 days of substantiation of the loss, theft, or compromise. a. True b. False

Answer: (b) False, [21CFR 1311.30]. The following persons are eligible to obtain a CSOS digital certificate from the DEA Certification Authority to sign electronic orders for controlled substances. (a). The person who signed the most recent DEA registration application or renewal application and a person authorized to sign a registration application. (b). A person granted power of attorney by a DEA registrant to sign orders for one or more schedules of controlled substances. A CSOS digital certificate issued by the DEA Certification Authority will authorize the certificate holder to sign orders for only those schedules of controlled substances covered by the registration under which the certificate is issued. Requirements for storing and using a private key for digitally signing orders: (a). Only the certificate holder may access or use his or her digital certificate and private key. (b). The certificate holder must provide FIPS-approved secure storage for the private key, as discussed by FIPS 140-2, 180-2, 186-2. (c). A certificate holder must ensure that no one else uses the private key. While the private key is activated, the certificate holder must prevent unauthorized use of that private key. (d). A certificate holder must not make back-up copies of the private key. (e). The certificate holder must report the loss, theft, or compromise of the private key or the password, via a revocation request, to the Certification Authority within 24 hours (NOT 7 days) of substantiation of the loss, theft, or compromise. Upon receipt and verification of a signed revocation request, the Certification Authority will revoke the certificate. The certificate holder must apply for a new certificate under the requirements of Sec. 1311.25.

The delivery of Morphine sulfate from Central fill pharmacy to a retail pharmacy must be accompanied with the properly filled DEA 222 order form. a. True b. False

Answer: (b) False, [21CFR1305.03]. Either a DEA Form 222 or its electronic equivalent is required for each distribution of a Schedule I or II controlled substance EXCEPT for the following: (a). Distributions to persons exempted from registration under Part 1301 of this chapter. (b). Exports from the United States that conform with the requirements of the Act. (c). Deliveries to a registered analytical laboratory or its agent approved by the DEA. (d). Delivery from a central fill pharmacy to a retail pharmacy. Central fill pharmacy: Central fill pharmacy means a pharmacy which is permitted by the state in which it is located to prepare controlled substances orders for dispensing pursuant to a valid prescription transmitted to it by a registered retail pharmacy and to return the labeled and filled prescriptions to the retail pharmacy for delivery to the ultimate user. Such central fill pharmacy shall be deemed "authorized" to fill prescriptions on behalf of a retail pharmacy only if the retail pharmacy and central fill pharmacy have a contractual relationship providing for such activities or share a common owner.

Which of the following information must be retrievable by the prescription number? I. The name and dosage form of the controlled substance. II. The date filled or refilled. III. The initials of the preparing technician for each refill. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [21CFR Section 1306.22(c)]. Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document or electronic prescription record. If entered on another document, such as a medication record, or electronic prescription record, the document or record must be uniformly maintained and readily retrievable. The following information must be retrievable by the prescription number: (1). The name and dosage form of the controlled substance. (2). The date filled or refilled. (3). The quantity dispensed. (4). The initials of the dispensing pharmacist (a preparing technician initial is NOT required) for each refill. (5). The total number of refills for that prescription. If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record, it shall be deemed that the full-face amount of the prescription has been dispensed.

The inventory for controlled substances should be taken at least: A. twice a year. B. once every two years. C. three times a year. D. every six months.

Answer: (b) Once every two years 1. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location. 2. An inventory taken by use of an oral recording device must be promptly transcribed. 3. Controlled substances shall be deemed to be "on hand" if they are in the possession of or under the control of the registrant, including substances returned by a customer, ordered by a customer but not yet invoiced, stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as complimentary samples. 4. A separate inventory shall be made for each registered location and each independent activity registered. 5. In the event controlled substances in the possession or under the control of the registrant are stored at a location for which he/she is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. The inventory may be taken either as of opening of business or as of the close of business on the inventory date and it shall be indicated on the inventory. 6. Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances. In the event a person commences business with no controlled substances on hand, he/she shall record this fact as the initial inventory. 7. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.

Which of the following drugs requires an exact count when taking inventory? a. Dalmane b. Concerta c. Halcion d. Tylenol No 3

Answer: (b) The inventory of Schedule II controlled drugs requires an exact count, [21CFR1304.11(e)(3)(i),(ii)]. Concerta (Methylphenidate) is a controlled II drug. Each person registered or authorized to dispense or conduct research with controlled substances shall conduct the inventory. In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser shall do as follows: (i). If the substance is listed in Schedule I or II, make an exact count or measure of the contents, or (ii). If the substance is listed in Schedule III, IV or V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he/she must make an exact count of the contents.

MS is an owner of Morgancare Pharmacy. Upon discontinuing his business, what shall be done with unused DEA 222 order forms? a. They must be properly destroyed. b. They must be marked "VOID" and sent to the nearest office of the DEA. c. The registrant shall destroy them after marking them "VOID". d. They must be destroyed in presence of DEA officers.

Answer: (b) They must be marked "VOID" and sent to the nearest office of the DEA, [21CFR1305.18]. In the case of discontinuation of controlled substance business, a registrant must notify the nearest DEA office 14 days prior to the date of discontinuation of the business. If a business has been transferred to another person, the registrant must return the registration certificate and unused DEA 222 forms to the DEA. The unused forms must be marked "VOID" before sending to the DEA. In the case of discontinuing a business without transferring it to another, the registrant still needs to return the certificate of registration and unexecuted DEA 222 order forms to the DEA.

A retrospective DUR is conducted by: a. Pharmacists b. Prescribers c. States' Health Improvement Facilities d. Nurses

Answer: (c) A retrospective DUR is defined as a study of Drug Utilization Review after dispensing has occurred, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. For example, a patient has received a prescription for Bactrim for the treatment of UTI. After taking the drug, the patient has suffered from severe hypersensitivity reactions and admitted to a hospital. Upon reviewing his case study, it has been found that the patient is allergic to sulfa drugs. This type of Drug Utilization Review where the problem is encountered after dispensing the drug is defined as a retrospective DUR. It is usually conducted by the States' Health Improvement Facilities.

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

An individual practitioner employed by a hospital shall write which of the following on controlled substances prescriptions? I. A DEA number of an individual practitioner II. The registration number of the hospital III. The special internal code number assigned to the individual practitioner by the hospital a. I only b. I and II only c. II and III only d. All

Answer: (c) II and III only, [21 CFR 1301.22 (C)]. An individual practitioner who is an agent or employee of a hospital or other institution may, when acting in the normal course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution which is registered in lieu of being registered him/herself, provided that: (1). Such dispensing, administering or prescribing is done in the usual course of his/her professional practice; (2). Such individual practitioner is authorized or permitted to do so by the jurisdiction in which he/she is practicing; (3). The hospital or other institution by whom he/she is employed has verified that the individual practitioner is so permitted to dispense, administer, or prescribe drugs within the jurisdiction; (4). Such individual practitioner is acting only within the scope of his/her employment in the hospital or institution; (5). The hospital or other institution authorizes the individual practitioner to administer, dispense or prescribe under the hospital registration and designates a specific internal code number for each individual practitioner so authorized. The code number shall consist of numbers, letters, or a combination thereof and shall be a suffix to the institution's DEA registration number, preceded by a hyphen (e.g., APO123456-10 or APO123456-A12); and (6). A current list of internal codes and the corresponding individual practitioners is kept by the hospital or other institution and is made available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner.

Which of the following agencies analyzes medication errors, near misses, and potentially hazardous conditions as reported by pharmacists and other practitioners? a. ASHP b. ACPE c. ISMP d. DRG

Answer: (c) ISMP (Institute for Safe Medication Practices) is an independent nonprofit agency that analyzes medication errors, near misses, and potentially hazardous conditions as reported by pharmacists and other practitioners. ISMP then makes appropriate contacts with companies and regulators, gathers expert opinion about prevention measures, and publishes its recommendations. To assist pharmacists in the process of minimizing the occurrence of medication errors, many state boards of pharmacy are contemplating or already requiring community pharmacies to have a continuous quality improvement program in place. Many of these state's regulations include the requirement of root cause analysis (RCA) in the case of sentinel events. The Joint Commission defines a sentinel event as an "unexpected occurrence involving death or serious physical or psychological injury or risk thereof," and recommends completing an RCA for all sentinel events for health care organizations in which they accredit. It is anticipated that RCA for sentinel events may be required as part of an accreditation program for community/ambulatory pharmacies.

The prescribing practitioner may authorize additional refills of Schedule III or IV controlled substances on the original prescription through an oral refill authorization transmitted to the pharmacist provided which of the following condition(s) is/are met? I. The total quantity authorized, including the amount of the original prescription, does not exceed five refills nor extend beyond six months from the date of issue of the original prescription. II. The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription. III. The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription the date, quantity of refill, number of additional refills authorized, and his or her initials. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21 CFR 1306.22 (e)]. The prescribing practitioner may authorize additional refills of Schedule III or IV controlled substances on the original prescription through an oral refill authorization transmitted to the pharmacist provided the following conditions are met: (1). The total quantity authorized, including the amount of the original prescription, does not exceed five refills nor extend beyond six months from the date of issue of the original prescription. (2). The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription or annotates the electronic prescription record with the date, quantity of refill, number of additional refills authorized, and initials the paper prescription or annotates the electronic prescription record showing who received the authorization from the prescribing practitioner who issued the original prescription. (3). The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription. (4). The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five-refill, six-month limitation.

For electronic prescriptions being transferred electronically, the transferring pharmacist must provide the receiving pharmacist with which of the following information? I. The date of the original dispensing. II. The number of refills remaining and the date(s) and locations of previous refills. III. The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21 CFR Section 1306.25 (b)(4)]. Paragraph (b)(4): For electronic prescriptions being transferred electronically, the transferring pharmacist must provide the receiving pharmacist with the following information in addition to the original electronic prescription data: (i). The date of the original dispensing. (ii). The number of refills remaining and the date(s) and locations of previous refills. (iii). The transferring pharmacy's name, address, DEA registration number, and prescription number for each dispensing. (iv). The name of the pharmacist transferring the prescription. (v). The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different. The pharmacist receiving a transferred electronic prescription must create an electronic record for the prescription that includes the receiving pharmacist's name and all of the information transferred with the prescription under paragraph (b)(4) of this section.

Which of the following is/are TRUE about the partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V? I. Each partial filling is recorded in the same manner as a refilling. II. The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. III. No dispensing occurs after 6 months after the date on which the prescription was issued. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [21CFR Section 1306.23]. The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that: (a). Each partial filling is recorded in the same manner as a refilling, (b). The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and (c). No dispensing occurs after 6 months after the date on which the prescription was issued.

Prospective DUR means the part of the drug utilization review program that: I. is to occur before the drug is dispensed. II. is designed to screen for potential drug therapy problems based on explicit and predetermined criteria and standards that are developed on an ongoing basis with professional input. III. is to provide for the counseling of recipients about the proper use of drugs. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. Prospective DUR means the part of the drug utilization review program that: I. Is to occur before the drug is dispensed. II. Is designed to screen for potential drug therapy problems based on explicit and predetermined criteria and standards that are developed on an ongoing basis with professional input. III. Is to provide for the counseling of recipients about the proper use of drugs. Whereas Retrospective DUR means the part of the drug utilization review program that assesses or measures drug use based on an historical review of drug use data against predetermined and explicit criteria and standards that are developed on an ongoing basis with professional input.

What information is/are required on a prescription for a controlled substance? I. Practitioner's name, address, and DEA registration number II. Manual signature of the prescriber III. Dosage form of the prescribed drug a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [http://www.deadiversion.usdoj.gov/faq/general.htm]. A prescription for a controlled substance must include the following information: 1. Date of issue; 2. Patient's name and address; 3. Practitioner's name, address, and DEA registration number; 4. Drug name; 5. Drug strength; 6. Dosage form; 7. Quantity prescribed; 8. Directions for use; 9. Number of refills (if any) authorized; and 10. Manual signature of prescriber. A prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner. An individual may be designated by the practitioner to prepare the prescriptions for his/her signature. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulation. Prescriptions for schedule II controlled substances must be written and be signed by the practitioner. In emergency situations, a prescription for a schedule II controlled substance may be telephoned to the pharmacy and the prescriber must follow up with a written prescription being sent to the pharmacy within seven days.

Medicare Part B covers which of the following? I. Services or supplies that are needed for the diagnosis or treatment of medical condition and meet accepted standards of medical practice. II. Health care to prevent illness or detect illness at an early stage, when treatment is most likely to work best. III. It covers outpatient care. a. I only b. I and II only c. II and III only d. All

Answer: (d) All. Medicare Part B covers medically-necessary services like doctors' services, outpatient care, and other medical services or supplies that are needed for the diagnosis or treatment of medical condition and meet accepted standards of medical practice. Medicare Part B covers things like: 1. Clinical research 2. Ambulance services 3. Durable medical equipment 4. Mental health a. Inpatient b. Outpatient c. Partial hospitalization 5. Getting a second opinion before surgery 6. Limited outpatient prescription drugs

Medicare-Part A covers which of the following? I. Inpatient care in hospitals. II. Hospice care services. III. Home health care services. a. I only b. I and II only c. II and III only d. All

Answer: (d) All. Medicare covers certain medical services and supplies in hospitals, doctors' offices, and other health care settings. Services are either covered under Medicare Part A (Hospital Insurance) or Medicare Part B (Medical Insurance). Part A covers the following: ___________________________ 1. Hospital care 2. Skilled nursing facility care 3. Nursing home care (as long as *custodial care isn't the only care you need) 3. Hospice care. 4. Home health services.

Which of the following pregnancy categories shows the highest risk to the developing fetus? a. Category A b. Category B c. Category D d. Category X

Answer: (d) Category X includes drugs that are extremely contraindicated to use during pregnancy by pregnant women. Category A: Controlled studies show no risk to the developing fetus. Category B: No evidence of risk in humans. Category C: Risk cannot be ruled out. Category D: Positive evidence of risk. Category X: Contraindicated during pregnancy.

Which of the following missing information cannot be filled by a distributor on a DEA Form 222? a. Date of the form b. Size of the package c. Strength of the drug d. Last Line Completed

Answer: (d) Last Line Completed cannot be filled by a distributor in sections omitted by a registrant on a DEA Form 222, [http://www.deadiversion.usdoj.gov/faq/dea222.htm]. Date of the form: The distributor may place the date on the form. When possible, the date ascertained from the delivery document should be used as the issue date. The form is acceptable unless the ascertained date of issue is greater than 60 days from the date of receipt. Size of the package: The size of the package must be completed by the purchaser unless the product is only manufactured in one size. If more than one package size is manufactured and no package size is indicated, then the package size may not be added by the supplier. The line item with the missing package size must be voided by the supplier and the purchaser notified. Strength of the drug: If the product is only manufactured in one strength, then it is not necessary to indicate the strength in the section "Name of Drug". If the product is available in more than one strength, then the strength may not be added by the distributor. The line should be voided on the DEA Form 222 by the supplier and the purchaser notified. Last Line Completed: A distributor may not fill in the "Last Line Completed" area of the DEA Form 222. This section must be completed by the purchaser. If the purchaser enters an incorrect number, such as the total number of packages ordered instead of the last line completed, then the DEA Form 222 is not valid.

Which of the following laws requires that drugs marketed in the U.S. must be safe as well as effective? a. Food, Drug and Cosmetic Act of 1938 b. Prescription Drug Marketing Act of 1987 c. Durham-Humphrey Amendment of 1951 d. Kefauver-Harris Amendment of 1962

Answer: (d) The Kefauver-Harris amendment of 1962 requires that drugs marketed in the US must be safe as well as effective. Features of the Kefauver-Harris amendment: 1. It is also known as the Drug Efficacy Amendment. It was issued in 1962. 2. It requires that all the marketed drugs in the US must be safe as well as effective. 3. This amendment also provides authority to the FDA to regulate prescription drug advertisement. Features of the Food Drug and Cosmetic Act: 1. It is stated that new drugs marketed in the US must have been proven safe when used according to labeled direction. 2. It was issued in 1938. 3. It was the first law that required adequate direction for using drugs. 4. The law also states that labels must contain warnings about any habit forming drugs. 5. It was the first law that was applied to food, drugs, cosmetics and medical devices. 6. Drugs marketed prior to 1938 such as Digoxin, Levothyroxine, Phenobarbital and Nitroglycerine are exempt from this law and are known as "grand fathered" drugs. Feature of the Prescription Marketing Act: 1. It was issued in 1987. 2. It was issued to control the distribution of drug samples. 3. It restricts the health care providers and facilities from reselling the drug samples. Features of the Durham-Humphrey Amendment: 1. It was issued in 1951. 2. It was the first law that set up the difference between prescription drugs and OTC drugs. 3. The law also allowed health care providers to authorize oral prescriptions and refills. 4. The law also states that the manufacturer of prescription drugs must provide a warning on the label that indicates: "Federal law prohibits dispensing without a prescription." Features of the Medical Device Act: 1. It was issued in 1976. 2. The intention of this law is to protect the American public from dangerous and useless devices. 3. This law sets the requirement for medical devices which includes GMP standard manufacturing and premarket approval requirements. Features of the Orphan Drug Act: 1. It was passed in 1983. 2. The term orphan describes the class of drugs that are used to treat diseases which affect very few people. 3. The intention of this law is to encourage pharmaceutical manufacturers to develop and synthesize orphan drugs. Features of the Drug Price Competition and Patent Term Restoration Act of 1984: 1. It was passed in 1984. It is also known as Waxman Hatch Amendment. 2. This law exempts the generic manufacturer from the lengthy drug approval process. This encourages generic manufacturers to develop more generic entities. 3. Also, it increases the patent-term for newly developed drugs. This encourages the innovator drug manufactures to develop newer entities.

All of the following are required on an OTC medication label EXCEPT: a. Inactive ingredients. b. Directions. c. Expiration date. d. NDC number.

Answer: (d) The following information is required on any OTC medication label, [21CFR201.2, 21CFR207.35, 21CFR201.6-201.63 and 21CFR201.1-201.55]: 1. Drug Facts - title 2. Active ingredient(s)-including amount in each dosage unit 3. Purpose - pharmacologic class 4. Use(s) - indications 5. Warnings 6. Do not use - absolute contraindications, when the product should not be used under any circumstances 7. Ask a doctor before use if you have - warnings for persons with certain preexisting conditions and for persons experiencing certain symptoms 8. Ask a doctor or pharmacist before use if you are - drug/drug and drug/food interactions 9. When using this product - side effects that could occur and substances or activities to avoid 10. Stop use and ask a doctor if - signs of toxicity and other serious reactions that would require consumers to stop using the product immediately 11. Pregnancy/breast-feeding warning 12. Keep out of reach of children/Accidental overdose warnings 13. Direction - dosage and when, how, or how often to take 14. Other information 15. Inactive ingredients 16. Questions? (Optional) - followed by telephone number 17. Lot number 18. Expiration date 19. Name and addresses of manufacturer or distributor The National Drug Code (NDC) number is requested but NOT required to appear on all drug labels (prescription as well as OTC) and in all drug labeling, including the label of any prescription drug container furnished to a consumer. If the NDC number is shown on a drug label, it shall be displayed as required in [21CFR207.35(b)(3)].

Which of the following are CII's? A. MS Contin B. Tylenol No. 3 C. Librium D. Redux

Answer: MS Contin (morphine sulfate) Other CII's: Alfentanil (Alfenta) Amobarbital (Amytal, Tuinal) Amphetamine (Dexedrine, Biphetamine) Lisdexamfetamine (Vyvanse) Coca Leaves Cocaine Codeine Dextropropoxyphene, bulk (non-dosage forms) Dihydrocodeine (Didrate, Parzone) Diphenoxylate Diprenorphine Ecgonine (Cocaine precursor, in Coca leaves) Ethylmorphine (Dionin) Fentanyl (Innovar, Sublimaze, Duragesic) Glutethimide (Doriden, Dorimide) Hydrocodone (dihydrocodeinone) Hydrocodone and isoquinoline alkaloidHydrocodone combination product (Tussionex, Tussend, Lortab, Vicodin, Hycodan, Anexsia) Hydromorphone (Dilaudid, dihydromorphinone) Levo-alphacetylmethadol (LAAM, long acting methadone, levomethadyl acetate) Meperidine (Demerol, Mepergan, pethidine) Methadone (Dolophine, Methadose, Amidone) Methamphetamine (Desoxyn, D-desoxyephedrine, ICE, Crank, Speed) Methylphenidate (Ritalin) Morphine (MS Contin, Roxanol, Duramorph, RMS, MSIR) Opium poppyOpium tinctureOpium, granulatedOpium, powderedOpium, raw**Oliceridine - Olinvyk (new schedule II drug) Oxycodone (OxyContin, Percocet, Tylox, Roxicodone, Roxicet) Oxymorphone (Numorphan) Pentobarbital (Nembutal) Poppy Straw ConcentrateRemifentanil (Ultiva) Secobarbital (Seconal, Tuinal) Sufentanil (Sufenta) Tapentadol (Nucynta)

A prescription for Ativan issued on 01/01/2021 should not be filled after: A. 04/01/2021 B. 07/01/2021 C. 10/01/2021 D. 01/01/2022

B. 07/01/2021 (a). No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued. No prescription for a controlled substance listed in Schedule III or IV authorized to be refilled may be refilled more than five times. (b). Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document or electronic prescription record. If entered on another document, such as a medication record, or electronic prescription record, the document or record must be uniformly maintained and readily retrievable. (c). The following information must be retrievable by the prescription number: (1). The name and dosage form of the controlled substance. (2). The date filled or refilled. (3). The quantity dispensed. (4). The initials of the dispensing pharmacist for each refill. (5). The total number of refills for that prescription. (d). If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record, it shall be deemed that the full face amount of the prescription has been dispensed.

_____________ is a comprehensive drug reporting system that monitors the flow of controlled substances (CS) from their point of manufacture through commercial distribution channels to the point of sale at the dispensing/retail level. A. FDACO B. ARCOS C. DEAXP D. FEDPMP

B. ARCOS Automation of Reports and Consolidated Orders System (ARCOS) Online Reporting System is a comprehensive drug reporting system that monitors the flow of controlled substances (CS) from their point of manufacture through commercial distribution channels to the point of sale at the dispensing/retail level. This newly added function will allow the more than 1,500 DEA-registered manufacturers and distributors to view the number of registrants who have sold a particular CS to a prospective customer in the last six months.

The partial filling of Schedule II controlled drugs is permitted for: I. A patient resides in an LTCF. II. A patient with a medical diagnosis documenting a terminal illness. III. A patient resides in the Medicare Certified Hospital.

B. I and II only 1. A prescription for a Schedule II controlled substance written for a patient in a Long Term Care Facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units. 2. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient."A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of the Act. 3. For each partial filling, 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 filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. 4. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. 5. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication. 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).

JD 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

B. Maximum three times The transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber's authorization.

Who publishes guidance for treating opioid use disorder (OUD)? A. FDA B. SAMHSA C. CDC D. DEA

B. SAMHSA To help broaden health care professionals' understanding of medications that can be used to treat Americans with opioid use disorder (OUD), the Substance Abuse and Mental Health Services Administration (SAMHSA) offers guidance on clinical best practices in the February 2018 publication titled Treatment Improvement Protocol, Medications for Opioid Use Disorder. The publication reviews the use of the three Food and Drug Administration (FDA)- approved medications used to treat OUD - methadone, naltrexone, and buprenorphine - and other strategies and services needed to support recovery for people with OUD. Additionally, in February 2018, SAMHSA released the publication Clinical Guidance for Treating Pregnant and Parenting Women with Opioid Use Disorder and Their Infants, which offers standard approaches for health care professionals. This publication provides evidence-based treatment options, including pharmacotherapy with methadone, buprenorphine, and buprenorphine/naloxone, for pregnant women with OUD. The clinical guidance also helps health care professionals and patients determine the most clinically appropriate action for a particular situation and informs individualized treatment decisions. Both publications can be found in the Publications section of SAMHSA's website at www.samhsa.gov

Why is a misfill considered misbranding?

Because you filled a medication that does NOT have a valid RX with it (Ex. You filled sildenafil instead of lisinopril). This sildenafil does not have a valid RX with it (1 problem), also now you do NOT have adequate directions for the patient. Remember, that part is ONLY exempt for valid RX

A filled DEA 222 order form must be kept available for an inspection for a period of at least: A. 1 year B. 4 years C. 2 years D. 6 months

C. 2 years Answer: (c) Two years, [21CFR1305.17(c)]. (a). The purchaser must retain a copy of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached. (b). The supplier must retain the original 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 a copy 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 Thiafentanil, 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. (e). Electronic copies of DEA Forms 222 will be deemed to be maintained separately from all other records of the registrant, for the purposes of this section, if such copies are readily retrievable separately from all other records. Electronic copies of DEA Forms 222 may be stored on a system at a location different from the registered location, provided such copies are readily retrievable at the registered location.

An emergency oral prescription for Schedule II controlled drugs must be delivered to the dispensing pharmacist by the prescribing individual practitioner within: A. 48 hours after an oral authorization. B. 72 hours after an oral authorization. C. 7 days after an oral authorization. D. 10 days after an oral authorization.

C. 7 days after an oral authorization. In the case of an emergency situation, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that: (1). The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a paper or electronic prescription signed by the prescribing individual practitioner); (2). The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in 1306.05, except for the signature of the prescribing individual practitioner; (3). If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity; and (4). Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of 1306.05, the prescription shall have written on its face "Authorization for Emergency Dispensing," and the date of the oral order. The paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7-day period. Upon receipt, the dispensing pharmacist must attach this paper prescription to the oral emergency prescription that had earlier been reduced to writing. For electronic prescriptions, the pharmacist must annotate the record of the electronic prescription with the original authorization and date of the oral order. The pharmacist must notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.

The partial supply of Schedule II controlled drugs must be filled by pharmacists within: A. 24 hours of initial filling. B. 48 hours of initial filling. C. 72 hours of initial filling. D. 1 week of initial filling.

C. 72 hours of initial filling. 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).

All of the following are Schedule I controlled drugs EXCEPT: A. Heroin B. LSD C. Demerol D. Marijuana

C. demerol (meperidine) Other Schedule I drugs: Difenoxin (Lyspafen) Dihydromorphine Etorphine (except hydrochloride salt) Heroin (Diacetylmorphine, diamorphine) Lysergic acid diethylamide (LSD, lysergide) Marijuana (Cannabis, marijuana) Mescaline Peyote

The partial supply on DEA 222 order forms must be filled within: A. 72 hours B. 10 days C. 48 hours D. 60 days

D. 60 days The partial supply on DEA 222 order forms must be filled within 60 days from the issued date, [21CFR1305.13 (d)].

__________ has published a new guide for clinicians intended to provide guidelines for tapering or discontinuing long-term opioid use. A. FDA B. DEA C. PPS D. HHS

D. HHS

Lomotil is classified as: A. Schedule II controlled drug B. Schedule III controlled drug C. Schedule IV controlled drug D. Schedule V controlled drug

D. Schedule V controlled drug List of Schedule V controlled drugs:**Newly Added: Codeine preparations - Not more than 0.2g per 100 ml or 0.1g (Robitussin AC, Phenergan with Codeine). Difenoxin preparations - Not more than 0.05 g Difenoxin + 0.00025g (25 mcg) Atropine sulfate (Motofen). Dihydrocodeine preparations - Not more than 0.1g per 100 ml or 100 gm. Diphenoxylate preparations- Not more than 2.5 mg Diphenoxylate + 25mcg Atropine sulfate (Lomotil, Logen). Ethylmorphine preparations - Not more than 100 mg per 100 ml or 100 gm. Opium preparations - Not more than 100 mg per 100 ml or 100 gm (Parepectolin, Kapectolin PG, Kaolin Pectin P.G.).

_____________ means a prescription order written by a prescriber that is not specific to and does not identify a particular patient. A. Prescription designated for an office use B. Prescription order C. Chart order D. Standing order

D. Standing order "Standing order" means a prescription order written by a prescriber that is not specific to and does not identify a particular patient.

Which act defined a supplement and allowed the addition of nutritional support statements?

Dietary Supplement Health and Education Act of 1994

Orphan Drug Act of 1983

Drugs intended for tx of rare diseases and conditions -Promotes research on rare diseases with a monetary benefit

Definition of misbranded

Drugs which are sold, DISPENSED, or distributed in violation of the labeling requirements of FDCA

Which act distinguishes RX vs. OTC?

Durham-Humphrey Amendment of 1951

What products are exempt from salicylate warning labeling (2)?

Effervescent preps Para-aminosalicylate ingredient (if it's the only salicylate product)

Central fill pharmacies may prepare prescriptions for a controlled substance listed in Schedule II upon receiving an oral authorization from an individual practitioner. T or F???

False Central fill pharmacies shall not be authorized to prepare prescriptions for a controlled substance listed in Schedule II upon receiving an oral authorization from a retail pharmacist or an individual practitioner

Which Act compelled safety testing before marketing?

Federal Food Drug and Cosmetic Act (FD&C) Act of 1938

What is required to be on a RX label (6 for federal)? What is added for IL law (1)

Federal: 1. Name/address of dispenser (pharmacy) 2. Serial # for RX 3. Date of RX filled 4. Name of prescriber 5. Name of patient (if stated on RX) 6. Directions for use, including precautions IL requires: Name of drug

Which of the following is/are classified as Mid-Level practitioners? I. RN II. MD III. DDS

I RN 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 and/or prescribe controlled substances by the state in which they practice.

"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" is not required for a Schedule II controlled drug if the schedule II: I. Drug is used for a double blind study. II. Drug is dispensed for terminally ill patients. III. Drug is dispensed when discharging a patient from an LTCF.

I. only The label of any drug listed as a "controlled substance" in schedule II, III, or IV of the Federal Controlled Substances Act shall, when dispensed to or for a patient, contain the following warning: "Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed." This statement is not required to appear on the label of a controlled substance dispensed for use in clinical investigations (e.g. a double blind study) which are "blind".

Which act discusses efficacy before marketing a product and drug advertisement?

Kefauver-Harris Amendment of 1962

If a package insert is not included for a patient, it is considered ____________

Misbranded

An office used by a practitioner (who is registered at another location in the same State) where controlled substances are prescribed but neither administered nor dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained. Does this place of business require a separate controlled substance registration?

No. A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person. The following locations shall be deemed NOT to be places where controlled substances are manufactured, distributed, or dispensed: (1). A warehouse where controlled substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registered locations other than the registered location from which the substances were delivered or to persons not required to register. (2). An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains such substances (other than substances for display purposes or lawful distribution as samples only) nor serves as a distribution point for filling sales orders; and (3). An office used by a practitioner (who is registered at another location in the same State or jurisdiction of the United States) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained.

Which act allowed FDA approved health claims on food labels and dietary supplements?

Nutrition Labeling and Education Act of 1990

What is compounding under 503B (4) ? What are you exempt from (2)? Definition?

Outsourcing Facilities -Large scale compounders -Registering with FDA is voluntary -No specific pt. -Customer is MD, hospital, or clinic -Exempt from NDA, labeling requirements -Must still use GMP

What must a RX have on the label?

RX only, which is short for: Caution: Federal law prohibits dispensing without a prescription

If you repackage an OTC, what must info must be there? (7)

Same as commercial product: -Name of product and category -Name/address of manufacturer -Established name of active/inactive ingredients -Any habit forming ingredients -How to store -How to use safely and effectively -Cautions

Who do all manufacturers and repackagers need to be registered with? What if they are not?

The FDA. If they are not, they are considered misbranded

An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription. A. True B. False

True (a). A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. (b). A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients. (c). A prescription may not be issued for "detoxification treatment" or "maintenance treatment," unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements in §1301.28 of this chapter.

Class III recall

Use/exposure is NOT likely to cause serious ADE

Class II recall

Use/exposure will cause TEMPORARY/medically reversible ADE

Can the FDA inspect a pharmacy?

Yes, but their scope is very limited

If a drug has not been dispensed yet and is just in the waiting bin and you notice the error, is it still considered misbranded/adulterated?

Yes.