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Change of pharmacist-in-charge of a pharmacy

(1). On the date of the change of the pharmacist-in-charge of a Class A, Class A-S, Class C, Class C-S, or Class F pharmacy, an inventory shall be taken. Such inventory shall include all stocks of all controlled substances (including any out-of-date drugs). (2). This inventory shall constitute, for the purpose of this section, the closing inventory of the departing pharmacist-in-charge and the beginning inventory of the incoming pharmacist-in-charge. (3). If the departing and the incoming pharmacists-in-charge are unable to conduct the inventory together, a closing inventory shall be conducted by the departing pharmacist-in-charge and a new and separate beginning inventory shall be conducted by the incoming pharmacist-in-charge. (4). The incoming pharmacist-in-charge shall be responsible for notifying the board within 10 days, as specified in §291.3 of this title (relating to Notifications), that a change of pharmacist-in-charge has occurred.

In Texas, the inventory of controlled substances should be done every:

(1). The pharmacist-in-charge shall be responsible for taking all required inventories, but may delegate the performance of the inventory to another person(s). (2). The inventory shall be maintained in a written, typewritten, or printed form. An inventory taken by use of an oral recording device must be promptly transcribed. (3). The inventory shall be kept in the pharmacy and shall be available for inspection for two years. (4). The inventory shall be filed separately from all other records. (5). The inventory shall be in a written, typewritten, or printed form and include all stocks of all controlled substances on hand on the date of the inventory (including any which are out-of-date). (6). The inventory may be taken either as of the opening of business or as of the close of business on the inventory date. (7). The inventory record shall indicate whether the inventory is taken as of the opening of business or as of the close of business on the inventory date. If the pharmacy is open 24 hours a day, the inventory record shall indicate the time that the inventory was taken. (8). The person(s) taking the inventory shall make an exact count or measure of all substances listed in Schedule II. (9). The person(s) taking the inventory shall make an estimated count or measure of all controlled substances listed in Schedule III, IV, and V, unless the container holds more than 1,000 tablets or capsules in which case, an exact count of the contents must be made. (10). The inventory of Schedule II controlled substances shall be listed separately from the inventory of Schedule III, IV, and V controlled substances. (11). If the pharmacy maintains a perpetual inventory of any of the drugs required to be inventoried, the perpetual inventory shall be reconciled on the date of the inventory. (b). Initial inventory: (1). A new Class A, Class A-S, Class C, Class C-S, or Class F pharmacy shall take an inventory on the opening day of business. Such inventory shall include all stocks of all controlled substances (including any out-of-date drugs). (2). In the event the Class A, Class A-S, Class C, Class C-S, or Class F pharmacy commences business with no controlled substances on hand, the pharmacy shall record this fact as the initial inventory. (3). The initial inventory shall serve as the pharmacy's inventory until the next May 1, or until the pharmacy's regular general physical inventory date, at which time the Class A, Class A-S, Class C, Class C-S, or Class F pharmacy shall take an annual inventory as specified in subsection (c) of this section. (c). Annual inventory: (1). A Class A, Class A-S, Class C, Class C-S, or Class F pharmacy shall take an inventory on May 1 of each year, or on the pharmacy's regular general physical inventory date. Such inventory may be taken within four days of the specified inventory date and shall include all stocks of all controlled substances (including out-of-date drugs). (2). A Class A, Class A-S, Class C, Class C-S, or Class F pharmacy applying for renewal of a pharmacy license shall include as a part of the pharmacy license renewal application a statement attesting that an annual inventory has been conducted, the date of the inventory, and the name of the person taking the inventory. (3). The person(s) taking the annual inventory and the pharmacist-in-charge shall indicate the time the inventory was taken (as specified in subsection (a)(7) of this section) and shall sign and date the inventory with the date the inventory was taken. The signature of the pharmacist-in-charge and the date of the inventory shall be notarized within three days after the day the inventory is completed, excluding Saturdays, Sundays, and federal holidays.

A prescribing practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance if:

(1). each separate prescription is issued for a legitimate medical purpose by a prescribing practitioner acting in the usual course of professional practice; (2). the prescribing practitioner provides instructions on each prescription to be filled at a later date indicating the earliest date on which a pharmacy may fill each prescription; (3). the prescribing practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse; and (4). the issuance of multiple prescriptions complies with other applicable state and federal laws.

According to Texas Pharmacy Law, a pharmacist may not fill a prescription for a controlled substance listed in Schedule II after how many days after the date on which the prescription is issued?

(1). if the prescription is for a Schedule II controlled substance, ensure the date the prescription is presented is not later than 21 days after the date of issuance; (2). if multiple prescriptions are issued by the prescribing practitioner allowing up to a 90-day supply of Schedule II controlled substances, ensure each prescription is neither filled prior to the earliest date intended by the practitioner nor filled beyond 21 days from the earliest date the prescription may be filled; (3). enter the date filled and the pharmacy prescription number; (4). indicate whether the pharmacy dispensed to the patient a quantity less than the quantity prescribed; and (5). if issued on an official prescription form, enter the following information, if different from the prescribing practitioner's information: (A). the brand name or, if none, the generic name of the controlled substance dispensed; or (B). the strength, quantity, and dosage form of the Schedule II controlled substance used to prepare the mixture or compound. (b). The prescription presented for filling is void, and a new prescription is required, if: (1). the prescription is for a Schedule II controlled substance, 21 days after issuance, or 21 days after any earliest fill date; or (2). the prescription is for a Schedule III, IV, or V controlled substance, more than six months after issuance or has been filled five times during the six months after issuance.

A confidential record is privileged and a pharmacist may release a confidential record only to:

(1). the patient or the patient's agent; (2). a practitioner or another pharmacist if, in the pharmacist's professional judgment, the release is necessary to protect the patient's health and well-being; (3). the board or to a person or another state or federal agency authorized by law to receive the confidential record; (4). a law enforcement agency engaged in investigation of a suspected violation of Chapter 481 or 483, Health and Safety Code, or the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.); (5). a person employed by a state agency that licenses a practitioner, if the person is performing the person's official duties; or (6). an insurance carrier or other third party payor authorized by the patient to receive the information.

A prescription for a controlled substance must show:

(1). the quantity of the substance prescribed: (A). numerically, followed by the number written as a word, if the prescription is written; (B). numerically, if the prescription is electronic; or (C). if the prescription is communicated orally or telephonically, as transcribed by the receiving pharmacist; (2). the date of issue; (2-a). if the prescription is issued for a Schedule II controlled substance to be filled at a later date under (multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance), the earliest date on which a pharmacy may fill the prescription; (3). the name, address, and date of birth or age of the patient or, if the controlled substance is prescribed for an animal, the species of the animal and the name and address of its owner; (4). the name and strength of the controlled substance prescribed; (5). the directions for use of the controlled substance; (6). the intended use of the substance prescribed unless the practitioner determines the furnishing of this information is not in the best interest of the patient; (7). the name, address, Federal Drug Enforcement Administration number, and telephone number of the practitioner at the practitioner's usual place of business, which must be legibly printed or stamped on a written prescription; and (8). if the prescription is handwritten, the signature of the prescribing practitioner. 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. Prescriptions for schedules III through V controlled substances may by written, oral or transmitted by fax.

automated checking device

(A). An automated checking device is a fully automated device which confirms, after a drug is prepared for distribution but prior to delivery to the patient, that the correct drug and strength has been labeled with the correct label for the correct patient. (B). The final check of a drug prepared pursuant to a medication order shall be considered accomplished using an automated checking device provided: (i). a check of the final product is conducted by a pharmacist prior to delivery to the patient or the following checks are performed by a pharmacist: (I). the prepackaged drug used to fill the order is checked by a pharmacist who verifies that the drug is labeled and packaged accurately; and (II). a pharmacist checks the accuracy of each original or new medication order. (ii). the medication order is prepared, labeled, and made ready for delivery to the patient in compliance with Class C (Institutional) Pharmacy rules; and (iii). prior to delivery to the patient: (I). the automated checking device confirms that the correct drug and strength has been labeled with the correct label for the correct patient; and (II). a pharmacist performs all other duties required to ensure that the medication order has been prepared safely and accurately as prescribed. (C). If the final check is accomplished as specified in subparagraph (B) of this paragraph, the following additional requirements must be met. (i). The pharmacy has conducted initial testing of the automated checking device and has a continuous quality assurance program which documents that the automated checking device accurately confirms that the correct drug and strength has been labeled with the correct label for the correct patient. (ii). The pharmacy documents and maintains: (I). the name(s), initials, or identification code(s) of each pharmacist responsible for the checks outlined in subparagraph (B)(i) of this paragraph; and (II). the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist, pharmacy technician, or pharmacy technician trainee who performs any other portion of the medication order preparation process. (iii). The pharmacy establishes mechanisms and procedures to test the accuracy of the automated checking device at least monthly.

floor stock method of drug distribution

(A). Prescription drugs and devices may be removed from the pharmacy only in the original manufacturer's container or prepackaged container. (B). Only a designated licensed nurse or practitioner may remove such drugs and devices. (C). A record shall be made at the time of withdrawal by the authorized person removing the drug or device; the record shall contain the following information: (i). name of the drug, strength, and dosage form; (ii). quantity removed; (iii). location of floor stock; (iv). date and time; and (v). signature (first initial and last name or full signature) or electronic signature of person making the withdrawal. (D). The pharmacist shall verify the withdrawal of drugs from the pharmacy after a reasonable interval, but in no event may such interval exceed seven days.

Every inventory or other record required to be kept under the provisions of the Texas Administrative Code shall be:

(A). kept by the pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and (B). supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in a mutually agreeable electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.

Within ten days after the closing of the pharmacy, the pharmacist-in-charge shall forward to the board a written notice of the closing which includes the following information:

(A). the actual date of closing; (B). the license issued to the pharmacy; (C). a statement attesting that an inventory has been conducted, and the manner by which the dangerous drugs and controlled substances possessed by the pharmacy were transferred or disposed. (D). if the pharmacy dispenses prescription drug orders, the name and address of the pharmacy to which the prescription drug orders, including refill information, and patient medication records were transferred. (E). If the pharmacy is registered to possess controlled substances, send a letter to the appropriate DEA divisional office explaining that the pharmacy has closed. Include the following items with the letter: (i). DEA registration certificate; (ii). all unused DEA order forms (222) with the word VOID written on the face of each order form; and (iii). copy 2 of any DEA order forms (222) used to transfer Schedule II controlled from the closed pharmacy.

Who may provide counseling under Texas State Pharmacy Law?

(a). A student-intern or an extended-intern participating in a board-approved internship program may perform any duty of a pharmacist provided the duties are delegated by and under the supervision of: (1). a pharmacist licensed by the board and approved as a preceptor by the board; or (2). a pharmacist licensed in a state other than Texas when working in a federal facility and serving as an instructor for a Texas college-based internship program.

instances an official prescription form is not required for a schedule II controlled drug

(a). An official prescription form is not required for a medication order written for a patient who is admitted to a hospital at the time the medication order is written and dispensed. (b). An official prescription form is not required in a long-term care facility (LTCF) if: (1). an individual administers the substance to an inpatient from the facility's medical emergency kit; (2). the individual administering the substance is an authorized practitioner or an agent acting under the practitioner's order; and (3). the facility maintains the proper records as required for an emergency medical kit in an LTCF. (c). An official prescription form is not required when a therapeutic optometrist administers a topical ocular pharmaceutical agent in compliance with: (1). the Texas Optometry Act; and (2). a rule adopted by the Texas Optometry Board under the authority of the Texas Optometry Act.

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.

Who appoints the members of the Texas State Pharmacy Board?

(a). The Texas State Board of Pharmacy consists of 11 members appointed by the governor with the advice and consent of the senate as follows: (1). seven members who are pharmacists; (2). one member who is a pharmacy technician; and (3). three members who represent the public. (a). The board must include representation for pharmacists who are primarily employed in Class A pharmacies and Class C pharmacies. (b). A pharmacist board member must, at the time of appointment: (1). be a resident of this state; (2). have been licensed for the five years preceding appointment; (3). be in good standing to practice pharmacy in this state; and (4). be practicing pharmacy in this state. A pharmacy technician board member must, at the time of appointment: (1). be a resident of this state; (2). have been registered as a pharmacy technician for the five years preceding appointment; (3). be in good standing to act as a pharmacy technician in this state; and (4). be acting as a pharmacy technician in this state. (c). Each person appointed to the board shall, not later than the 15th day after the date of appointment, qualify by taking the constitutional oath of office.

partial filling of C-II for terminally ill pts

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. If there is any question about whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner before partially filling the prescription. Both the pharmacist and the practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. 3. The pharmacist must record the prescription on an official prescription form and must indicate on the form 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" is considered to have been filled in violation of this chapter. 4. For each partial filling, the dispensing pharmacist shall record on the back of the official prescription form the date of the partial filling, the quantity dispensed, the remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. Before any subsequent partial filling, the pharmacist must determine that the additional partial filling is necessary. 5. The total quantity of Schedule II controlled substances dispensed in all partial fillings may not exceed the total quantity prescribed. 6. Schedule II prescriptions for patients in a long-term care facility or patients with a medical diagnosis documenting a terminal illness are valid for a period not to exceed 60 days following the issue date unless sooner terminated by discontinuance of the medication. A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" is considered to have been filled in violation of Texas Pharmacy Law.

The extent of inspection by a Board-authorized agent must be limited to the following:

1. Inspect and copy documents, including records or reports. 2. Inspect a pharmacy's storage, equipment, security, prescription drugs, devices, or records. 3. Perform an inventory of any stock of prescription drugs or devices in a pharmacy and obtain samples of those substances. However, this inspection may not extend to: 1. Financial data of pharmacy. 2. Sales data, other than shipment data. 3. Pricing data.

ratio of pharmacists to pharmacist-interns when performing pharmacy technician duties

1:1

A consultant pharmacist may use a waste disposal service to destroy:

A consultant pharmacist may utilize a waste disposal service to destroy dangerous drugs dispensed to patients in health care facilities or institutions. A consultant pharmacist may not use a waste disposal service to destroy controlled substances unless allowed to do so by federal laws or rules of the Drug Enforcement Administration. Dangerous drugs may be transferred to a waste disposal service for destruction provided the following conditions are met. (A). The waste disposal service is in compliance with applicable rules of the Texas Commission on Environmental Quality and United States Environmental Protection Agency relating to waste disposal. (B). The drugs are inventoried and such inventory is verified by the consultant pharmacist prior to placing the drugs in an appropriate container, and sealing the container. The following information must be included on this inventory: (i). name and address of the facility or institution; (ii). name and pharmacist license number of the consultant pharmacist; (iii). date of packaging and sealing of the container; (iv). date the prescription was dispensed; (v). unique identification number assigned to the prescription by the pharmacy; (vi). name of dispensing pharmacy; (vii). name, strength, and quantity of drug; (viii). signature of consultant pharmacist packaging and sealing the container; and (ix). signature of the witness(es). (C). The consultant pharmacist seals the container of drugs in the presence of the facility administrator and the director of nursing or one of the other witnesses listed in paragraph (1)(E) of this subsection as follows: (i). tamper resistant tape is placed on the container in such a manner that any attempt to reopen the container will result in the breaking of the tape; and (ii). the signature of the consultant pharmacist is placed over this tape seal. (D). The sealed container is maintained in a secure area at the facility or institution until transferred to the waste disposal service by the consultant pharmacist, facility administrator, director of nursing, or acting director of nursing. (E). A record of the transfer to the waste disposal service is maintained and attached to the inventory of drugs specified in subparagraph (B) of this paragraph. Such record shall contain the following information: (i). date of the transfer; (ii). signature of the person who transferred the drugs to the waste disposal service; (iii). name and address of the waste disposal service; and (iv). signature of the employee of the waste disposal service who receives the container. (F). The waste disposal service shall provide the facility with proof of destruction of the sealed container. Such proof of destruction shall contain the date, location, and method of destruction of the container and shall be attached to the inventory of drugs specified in subparagraph (B) of this paragraph. (3). Record retention. All records required in this subsection shall be maintained by the consultant pharmacist at the health care facility or institution for two years from the date of destruction.

How many hours of continuing education are required for a pharmacist under Texas State Pharmacy Law?

A license to practice pharmacy expires on the last day of the assigned expiration month. The Texas State Board of Pharmacy shall require biennial renewal of all pharmacist licenses provided under the Pharmacy Act 295.5. To renew a license to practice pharmacy, a pharmacist must report on the renewal application completion of at least thirty contact hours (3.0 CEUs) of continuing education. For renewals received after **January 1, 2015**, at least one contact hour (0.1 CEU) shall be related to Texas pharmacy laws or rules. Each license holder shall maintain records for three years showing the continuing education programs completed by the license holder. A pharmacist who practices pharmacy without a current renewal certificate is subject to all penalties of practicing pharmacy without a license including the delinquent fees specified in the Act.

What duties can be performed by an Intern-Trainee working under the direct supervision of the pharmacist preceptor?

A pharmacist preceptor serving as an instructor for a Texas college/school-based internship program, may delegate the following duties to an intern-trainee working in a site assigned by a Texas college/school of pharmacy board approved program provided the intern-trainee is under the direct supervision of the pharmacist preceptor: (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; (6). reconstituting medication; (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). bulk compounding; (10). compounding non-sterile preparations provided the intern-trainee has completed the training required for pharmacists in §291.131 of this title (relating to Pharmacist Compounding Non-sterile Preparations); (11). compounding sterile preparations provided the intern-trainee has completed the training required for pharmacists in §291.133 of this title (relating to Pharmacies Compounding Sterile Preparations); and (12). administering immunizations provided the intern-trainee has completed the training required for pharmacists in §295.15 of this title (relating to Administration of Immunizations or Vaccinations by a Pharmacist under Written Protocol of a Physician).

change of address, giving the old and new address for pharmacists, interns, & techs

A pharmacist-intern shall notify the board electronically or in writing within 10 days of a change of address, giving the old and new address. A pharmacist-intern shall also notify the board in writing within 10 days of a change of name by: (A). sending a copy of the official document reflecting the name change (e.g., marriage certificate, divorce decree, etc.); (B). returning the current pharmacist-intern certificate which reflects the previous name; and (C). paying a fee of $20. Pharmacist: (a). Change of address. A pharmacist shall notify the board in writing within 10 days of a change of address, giving the old and new address and license number. (b). Change of name. (1). A pharmacist shall notify the board in writing within 10 days of a change of name by: (A). sending a copy of the official document reflecting the name change (e.g., marriage certificate, divorce decree, etc.); and (B). paying a fee of $20. (2). Pharmacists who change their name may retain the original license to practice pharmacy (wall certificate). However, if the pharmacist wants an amended certificate issued which reflects the pharmacist's name change, the pharmacist must: (A). return the original certificate; and (B). pay a fee of $35. (3). An amended license and/or certificate reflecting the new name of the pharmacist will be issued by the board. A pharmacist shall report in writing to the board within 10 days of a change of employment and be responsible for seeing that his or her name is removed from the pharmacy license of last employment and added to the pharmacy license of new employment. Pharmacy technician: (a). Change of Address and/or Name. (1). Change of address. A pharmacy technician or pharmacy technician trainee shall notify the board electronically or in writing within 10 days of a change of address, giving the old and new address and registration number. (2). Change of name. (A). A pharmacy technician or pharmacy technician trainee shall notify the board in writing within 10 days of a change of name by: (i). sending a copy of the official document reflecting the name change (e.g., marriage certificate, divorce decree, etc.); and (ii). paying a fee of $20. (B). An amended registration and/or certificate reflecting the new name of the pharmacy technician or pharmacy technician trainee will be issued by the board. (b). Change of Employment. A pharmacy technician or pharmacy technician trainee shall report electronically or in writing to the board within 10 days of a change of employment giving the name and license number of the old and new pharmacy and registration number.

List of Schedule II controlled drugs

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 alkaloid Hydrocodone 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 poppy Opium tincture Opium, granulated Opium, powdered Opium, raw Oxycodone (OxyContin, Percocet, Tylox, Roxicodone, Roxicet) Oxymorphone (Numorphan) Pentobarbital (Nembutal) Poppy Straw Concentrate Remifentanil (Ultiva) Secobarbital (Seconal, Tuinal) Sufentanil (Sufenta) Tapentadol (Nucynta)

List of Schedule III controlled drugs

Amobarbital and noncontrolled active ingredients Amobarbital suppository dosage form Anabolic steroids Barbituric acid derivative Benzphetamine (Didrex, Inapetyl) Buprenorphine (Buprenex, Temgesic) Butabarbital (Butisol, Butibel) Butalbital (Fiorinal, Butalbital with aspirin) Codeine and isoquinoline alkaloid (Codeine with papaverine or noscapine) Codeine combination product (Empirin, Fiorinal, Tylenol, ASA or APAP w/codeine) Dronabinol in sesame oil in soft gelatin capsule (Marinol) Lysergic acid Lysergic acid amide Methyltestosterone (Android, Oreton, Testred, Virilon) Nalorphine (Nalline) Nandrolone (Deca-Durabolin, Durabolin, Durabolin-50) Norethandrolone(Nilevar, Solevar) Opium combination product (Paregoric) Pentobarbital and noncontrolled active ingredients Pentobarbital suppository dosage form Phendimetrazine (Bontril) Secobarbital and noncontrolled active ingredients Secobarbital suppository dosage form Testosterone (Android-T, Androlan, Depotest, Delatestryl) Thiopental (Pentothal)

Stocking of drugs in an automated pharmacy system shall be completed by:

An automated pharmacy system is a mechanical system that dispenses prescription drugs and maintains related transaction information. The pharmacist-in-charge of the provider pharmacy is responsible for all pharmacy operations involving the automated pharmacy system located at the remote site including supervision of the automated pharmacy system and compliance with this section. A Class A or Class C Pharmacy shall make application to the board to provide remote pharmacy services using an automated pharmacy system. The application shall contain an affidavit with the notarized signatures of the pharmacist-in-charge, and the medical director or the person responsible for the on-site operation of the facility (e.g., administrator, chief operating officer, owner, chief executive officer), and include the following: (I). the name, address, and license number of the provider pharmacy; (II). name and address of the facility where the remote pharmacy services will be provided; (III). a statement indicating that the provider pharmacy and the facility have entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract or agreement in compliance with federal and state laws and regulations; and (IV). documentation that the automated pharmacy system is located where medications are administered by license healthcare professionals. (i). Drugs for use in an automated pharmacy system shall be packaged in the original manufacturer's container or be prepackaged in the provider pharmacy and labeled in compliance with the board's prepackaging requirements for the class of pharmacy. (ii). Drugs dispensed from the automated pharmacy system may be returned to the pharmacy for reuse provided the drugs are in sealed, tamper evident packaging which has not been opened. (iii). Stocking of drugs in an automated pharmacy system shall be completed by a pharmacist, pharmacy technician, or pharmacy technician trainee under the direct supervision of a pharmacist. (iv). If the automated pharmacy system uses removable cartridges or containers to hold drugs, the prepackaging of the cartridges or containers shall occur at the provider pharmacy unless provided by an FDA approved repackager. The prepackaged cartridges or containers may be sent to the remote site to be loaded into the machine by personnel designated by the pharmacist-in-charge provided: (I). a pharmacist verifies the cartridge or container has been properly filled and labeled; (II). the individual cartridges or containers are transported to the remote site in a secure, tamper-evident container; and (III). the automated pharmacy system uses bar-coding, microchip, or other technologies to ensure that the containers are accurately loaded in the automated pharmacy system.

MJ 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?

Answer: Maximum 3 times 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.

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)?

Answer: 152 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.

How many hours of pharmacist preceptor training are required to renew a preceptor certification? a. None b. 3 hours c. 5 hours d. 2 hours

Answer: 3 A preceptor shall complete: (i). for initial certification, three hours of pharmacist preceptor training provided by an ACPE approved provider within the previous two years. Such training shall be: (I). developed by a Texas college/school of pharmacy; or (II). approved by: a. a committee comprised of the Texas college/schools of pharmacy; or b. the board; or (ii). to continue certification, three hours of pharmacist preceptor training provided by an ACPE approved provider within the pharmacist's current license renewal period. Such training shall be: (I). developed by a Texas college/school of pharmacy; or (II). approved by: a. a committee comprised of the Texas college/schools of pharmacy; or b. the board.

A prescription for Cephalexin 500 mg has been prescribed and presented by Dr. Shah on January 20, 2017 with the direction: 1 cap po qid x 10 days. If the bulk bottle of Cephalexin has an expiration date of Jan/17, what would be the minimum quantity that should be dispensed by the pharmacist?

Answer: 40 The bulk bottle of Cephalexin has an expiration date of Jan/17, which indicates that the drug will be expiring on January 31, 2017. The prescription is presented on January 20 and is written for 10 days, therefore the pharmacist can fill the whole supply of the drug.

Which of the following information is/are TRUE about the satellite pharmacy? I. A Class A or Class C provider pharmacy may establish a satellite pharmacy in a location that is not at the same location as a Class A or Class C pharmacy. II. The pharmacist-in-charge of the provider pharmacy is responsible for all pharmacy operations involving the satellite pharmacy including supervision of satellite pharmacy personnel III. A satellite pharmacy may not store bulk drugs and may only store prescription medications that have been previously verified and dispensed by the provider pharmacy.

Answer: All (1). A Class A or Class C provider pharmacy may establish a satellite pharmacy in a location that is not at the same location as a Class A or Class C pharmacy. (2). The pharmacist-in-charge of the provider pharmacy is responsible for all pharmacy operations involving the satellite pharmacy including supervision of satellite pharmacy personnel and compliance with this section. (3). A satellite pharmacy may not store bulk drugs and may only store prescription medications that have been previously verified and dispensed by the provider pharmacy. (4). The provider pharmacy and the satellite pharmacy must have: (A). the same owner; and (B). share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to process a non-dispensing function. (6). All individuals working at the satellite pharmacy shall be employees of the provider pharmacy and must report their employment to the board as such. (7). A satellite pharmacy shall have sufficient pharmacists on duty to operate the satellite pharmacy competently, safely, and adequately to meet the needs of the patients of the pharmacy. (8). Duties, in a satellite pharmacy, that may only be performed by a pharmacist are as follows: (A). receiving oral prescription drug orders and reducing these orders to writing, either manually or electronically; (B). interpreting or clarifying prescription drug orders; (C). communicating to the patient or patient's agent information about the prescription drug or device which in the exercise of the pharmacist's professional judgment, the pharmacist deems significant, as specified in §291.33(c) of this title; (D). communicating to the patient or the patient's agent on his or her request information concerning any prescription drugs dispensed to the patient by the pharmacy; (E). assuring that a reasonable effort is made to obtain, record, and maintain patient medication records; (F). interpreting patient medication records and performing drug regimen reviews; and (G). performing a specific act of drug therapy management for a patient delegated to a pharmacist by a written protocol from a physician licensed in this state in compliance with the Medical Practice Act.

At the time of delivery of the drug, the dispensing container shall bear a label containing: I. if the pharmacist has selected a generically equivalent drug, the statement "Substituted for Brand Prescribed". II. the name of the advanced practice nurse and the name of the supervising physician, if the prescription is carried out or signed by an advanced practice nurse. III. the name of the pharmacist who signed the prescription for a dangerous drug under delegated authority of a physician and the name of the supervising physician.

Answer: All (A). At the time of delivery of the drug, the dispensing container shall bear a label in plain language and printed in an easily readable font size, unless otherwise specified, with at least the following information: (i). name, address and phone number of the pharmacy; (ii). unique identification number of the prescription that is printed in an easily readable font size comparable to but no smaller than ten-point Times Roman; (iii). date the prescription is dispensed; (iv). initials or an identification code of the dispensing pharmacist; (v). name of the prescribing practitioner; (vi). name of the patient or if such drug was prescribed for an animal, the species of the animal and the name of the owner that is printed in an easily readable font size comparable to but no smaller than ten-point Times Roman; (vii). instructions for use that is printed in an easily readable font size comparable to but no smaller than ten-point Times Roman; (viii). quantity dispensed; (ix). 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; (x). if the prescription is for a Schedules 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"; (xi). if the pharmacist has selected a generically equivalent drug pursuant to the provisions of the Act, Chapters 562 and 563, the statement "Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where "Brand Name" is the actual name of the brand name product prescribed; (xii). the name of the advanced practice nurse or physician assistant and the name of the supervising physician, if the prescription is carried out or signed by an advanced practice nurse or physician assistant; (xiii). the name of the pharmacist who signed the prescription for a dangerous drug under delegated authority of a physician, and the name of the supervising physician; (xiv). the name and strength of the actual drug product dispensed that is printed in an easily readable font size comparable to but no smaller than ten-point Times Roman, unless otherwise directed by the prescribing practitioner; (xv). if the drug is dispensed in a container other than the manufacturer's original container, the date after which the prescription should not be used or beyond-use-date. Unless otherwise specified by the manufacturer, the beyond-use-date shall be one year from the date the drug is dispensed or the manufacturer's expiration date, whichever is earlier. The beyond-use-date may be placed on the prescription label or on a flag label attached to the bottle.

Which of the following should be part of Drug Regimen Review? I. Drug-food interaction. II. Duplication of therapy. III. Direction for use.

Answer: All (A). Drug utilization review: A systematic ongoing process of drug utilization review shall be developed in conjunction with the medical staff to increase the probability of desired patient outcomes and decrease the probability of undesired outcomes from drug therapy. (B). Drug regimen review. (i). For the purpose of promoting therapeutic appropriateness, a pharmacist shall evaluate medication orders and patient medication records for: (I). known allergies; (II). rational therapy--contraindications; (III). reasonable dose and route of administration; (IV). reasonable directions for use; (V). duplication of therapy; (VI). drug-drug interactions; (VII). drug-food interactions; (VIII). drug-disease interactions; (IX). adverse drug reactions; (X). proper utilization, including over-utilization or underutilization; and (XI). clinical laboratory or clinical monitoring methods to monitor and evaluate drug effectiveness, side effects, toxicity, or adverse effects, and appropriateness to continued use of the drug in its current regimen. (ii). The drug regimen review shall be conducted on a prospective basis when a pharmacist is on duty, except for an emergency order, and on a retrospective basis as specified in subsection (e)(1) of this section when a pharmacist is not on duty.

Which of the following is/are TRUE about reusing a prescription dispensing container? I. In most circumstances, prescription containers or closures shall not be re-used. II. A prescription container may be reused provided the container is reused for the same patient. III. If a patient or patient's agent has difficulty reading or understanding a prescription label, a prescription container may be reused provided the container is designed to provide audio-recorded information about the proper use of the prescription medication.

Answer: All (C). Prescription containers or closures shall not be re-used. However, if a patient or patient's agent has difficulty reading or understanding a prescription label, a prescription container may be reused provided: (i). the container is designed to provide audio-recorded information about the proper use of the prescription medication; (ii). the container is reused for the same patient; (iii). the container is cleaned; and (iv). a new safety closure is used each time the prescription container is reused.

The dispensing container is not required to bear the label if: I. the drug is prescribed for administration to an ultimate user who is institutionalized in a licensed health care institution. II. no more than a 90-day supply is dispensed at one time. III. the drug is not in the possession of the ultimate user prior to administration.

Answer: All (C). The dispensing container is not required to bear the label if: (i). the drug is prescribed for administration to an ultimate user who is institutionalized in a licensed health care institution (e.g., nursing home, hospice, hospital); (ii). no more than a 90-day supply is dispensed at one time; (iii). the drug is not in the possession of the ultimate user prior to administration; (iv). the pharmacist-in-charge has determined that the institution: (I). maintains medication administration records which include adequate directions for use for the drug(s) prescribed; (II). maintains records of ordering, receipt, and administration of the drug(s); and (III). provides for appropriate safeguards for the control and storage of the drug(s);

Which of the following information is/are TRUE ABOUT official prescription forms? I. A practitioner may order official prescription forms from the board only if the practitioner is registered by the DEA to prescribe a Schedule II controlled substance. II. An institutional practitioner authorized by a hospital or institution to prescribe a Schedule II controlled substance under the DEA registration of the hospital or institution may order official prescription forms if the appropriate state health regulatory agency has assigned an institutional permit number to the practitioner. III. Advanced practice registered nurses or physician assistants may only use the official prescription forms issued with their name, address, phone number, and DEA numbers, and the delegating physician's name and DEA number.

Answer: All (a). A practitioner may order official prescription forms from the board only if the practitioner is registered by the DEA to prescribe a Schedule II controlled substance. (b). The board is the sole source for the official prescription forms. However, official prescription forms issued prior to September 1, 2016, by the Texas Department of Public Safety are valid forms. (c). This subsection applies only to an institutional practitioner who is employed by a hospital or other training institution. An institutional practitioner authorized by a hospital or institution to prescribe a Schedule II controlled substance under the DEA registration of the hospital or institution may order official prescription forms under this section if: (1). the practitioner prescribes a controlled substance in the usual course of the practitioner's training, teaching program, or employment at the hospital or institution; (2). the appropriate state health regulatory agency has assigned an institutional permit or similar number to the practitioner; and (3). the hospital or institution: (A). maintains a current list of each institutional practitioner and each assigned institutional permit number; and (B). makes the list available to another registrant or a member of a state health regulatory or law enforcement agency for the purpose of verifying the authority of the practitioner to prescribe the substance. (d). An advanced practice registered nurse or physician assistant operating under a prescriptive authority agreement pursuant to Texas Occupations Code, Chapter 157 may order official prescription forms under this section if authority to prescribe has been delegated by a physician. Upon withdrawal of the delegating physician's authority such forms are void and must be returned to the board. Advanced practice registered nurses or physician assistants may only use the official prescription forms issued with their name, address, phone number, and DEA numbers, and the delegating physician's name and DEA number. The official prescription order form must be signed by the requesting advanced practice registered nurse or physician assistant, and by the delegating physician.

What are requirements to become a registered pharmacy technician? I. An applicant shall have a high school or equivalent diploma (e.g., GED). II. An applicant shall have taken and passed the Pharmacy Technician Certification Board's National Pharmacy Technician Certification Examination. III. An applicant shall have completed the Texas application for pharmacy technician registration.

Answer: All (c). Initial registration for pharmacy technicians: (1). Each applicant for pharmacy technician registration shall: (A). have a high school or equivalent diploma (e.g., GED), or be working to achieve a high school or equivalent diploma. For the purpose of this clause, an applicant for registration may be working to achieve a high school or equivalent diploma for no more than two years; and (B). either have: (i). taken and passed the Pharmacy Technician Certification Board's National Pharmacy Technician Certification Examination or other examination approved by the board and have a current certification certificate; or (ii). been granted an exemption from certification by the board as specified in §297.7 of this title (relating to Exemption from Pharmacy Technician Certification Requirements); and (C). complete the Texas application for registration that includes the following information: (i). name; (ii). addresses, phone numbers, date of birth, and social security number; and (iii). any other information requested on the application. (D). meet all requirements necessary in order for the Board to access the criminal history record information, including submitting fingerprint information and paying the required fees; and (E). pay the registration fee specified in §297.4 of this title (relating to Fees). (d) Renewal: (B). pay the renewal fee specified in §297.4 of this title; and (C). complete 20 contact hours of continuing education per renewal period as specified in §297.8 of this title (relating to Continuing Education). For renewals received after January 1, 2015, at least one contact hour of the 20 contact hours specified in paragraph (2) of this subsection shall be related to Texas pharmacy laws or rules.

Which of the following is/are TRUE when an automated medication supply system is used to store or distribute medications for administration pursuant to medication orders? I. A pharmacist shall review the new medication order prior to withdrawal from the automated medication supply system. II. A pharmacist shall review the new medication order retrospectively within 72 hours in a facility with a full-time pharmacist when a pharmacist is not on duty at the time the order is made. III. A pharmacist shall review the new medication order retrospectively within 7 days in a facility with a part-time or consultant pharmacist when a pharmacist is not on duty at the time the order is made.

Answer: All (i). When an automated medication supply system is used to store or distribute medications for administration pursuant to medication orders, it shall be operated according to written policies and procedures of operation. The policies and procedures of operation shall establish requirements for operation of the automated medication supply system and shall describe policies and procedures that: (I). include a description of the policies and procedures of operation; (II). provide for a pharmacist's review and approval of each original or new medication order prior to withdrawal from the automated medication supply system: (-a-). before the order is filled when a pharmacist is on duty except for an emergency order; (-b-). retrospectively within 72 hours in a facility with a full-time pharmacist when a pharmacist is not on duty at the time the order is made; or (-c-). retrospectively within 7 days in a facility with a part-time or consultant pharmacist when a pharmacist is not on duty at the time the order is made; (III). provide for access to the automated medication supply system for stocking and retrieval of medications which is limited to licensed healthcare professionals, pharmacy technicians, or pharmacy technician trainees acting under the supervision of a pharmacist; (IV). provide that a pharmacist is responsible for the accuracy of the restocking of the system. The actual restocking may be performed by a pharmacy technician or pharmacy technician trainee; (V). provide for an accountability record to be maintained which documents all transactions relative to stocking and removing medications from the automated medication supply system; (VI). require a prospective or retrospective drug regimen review is conducted as specified in subsection (g) of this section; and (VII). establish and make provisions for documentation of a preventative maintenance program for the automated medication supply system. (ii).A pharmacy which uses an automated medication supply system to fill medication orders shall, at least annually, review its written policies and procedures, revise them if necessary, and document the review.

The pharmacist may receive credit towards their continuing education requirement for completion of which of the following programs? I. CPR certification by the American Red Cross. II. Advanced cardiovascular life support certification by the American Heart Association. III. For attending a full, public pharmacy board business meeting.

Answer: All 1). Basic cardiopulmonary resuscitation (CPR) courses which lead to CPR certification by the American Red Cross or the American Heart Association or its equivalent shall be recognized as approved programs. Pharmacists may receive credit for one contact hour (0.1 CEU) towards their continuing education requirement for completion of a CPR course only once during a license period. Proof of completion of a CPR course shall be the certificate issued by the American Red Cross or the American Heart Association or its equivalent. 2). Advanced cardiovascular life support courses (ACLS) or pediatric advanced life support (PALS) courses which lead to initial ACLS or PALS certification by the American Heart Association or its equivalent shall be recognized as approved programs. Pharmacists may receive credit for twelve contact hours (1.2 CEUs) towards their continuing education requirement for completion of an ACLS or PALS course only once during a license period. Proof of completion of an ACLS or PALS course shall be the certificate issued by the American Heart Association or its equivalent. 3). Advanced cardiovascular life support courses (ACLS) or pediatric advanced life support (PALS) courses which lead to ACLS or PALS recertification by the American Heart Association or its equivalent shall be recognized as approved programs. Pharmacists may receive credit for four contact hours (0.4 CEUs) towards their continuing education requirement for completion of an ACLS or PALS recertification course only once during a license period. Proof of completion of an ACLS or PALS recertification course shall be the certificate issued by the American Heart Association or its equivalent. 4). Attendance at Texas State Board of Pharmacy Board Meetings shall be recognized for continuing education credit as follows. (A). Pharmacists shall receive credit for three contact hours (0.3 CEUs) towards their continuing education requirement for attending a full, public board business meeting in its entirety. (B). A maximum of six contact hours (0.6 CEUs) are allowed for attendance at a board meeting during a license period. (C). Proof of attendance for a complete board meeting shall be a certificate issued by the Texas State Board of Pharmacy. 5). Participation in a Texas State Board of Pharmacy appointed Task Force shall be recognized for continuing education credit as follows. (A). Pharmacists shall receive credit for three contact hours (0.3 CEUs) towards their continuing education requirement for participating in a Texas State Board of Pharmacy appointed Task Force. (B). Proof of participation for a Task Force shall be a certificate issued by the Texas State Board of Pharmacy. 6). Completion of an Institute for Safe Medication Practices' (ISMP) Medication Safety Self Assessment for hospital pharmacies or for community/ambulatory pharmacies shall be recognized for continuing education credit as follows. (A). Pharmacists shall receive credit for three contact hours (0.3 CEUs) towards their continuing education requirement for completion of an ISMP Medication Safety Self Assessment. (B). Proof of completion of an ISMP Medication Safety Self Assessment shall be: (i). a continuing education certificate provided by an ACPE approved provider for completion of an assessment; or (ii). a document from ISMP showing completion of an assessment. 7). Pharmacists shall receive credit for three contact hours (0.3 CEUs) toward their continuing education requirements for taking and successfully passing the initial Geriatric Pharmacy Practice certification examination administered by the Commission for Certification in Geriatric Pharmacy. Proof of successfully passing the examination shall be a certificate issued by the Commission for Certification in Geriatric Pharmacy. 8). Pharmacist shall receive credit for three contact hours (0.3 CEUs) toward their continuing education requirements for taking and successfully passing an initial Board of Pharmaceutical Specialties certification examination administered by the Board of Pharmaceutical Specialties. Proof of successfully passing the examination shall be a certificate issued by the Board of Pharmaceutical Specialties.

Which of the following is/are TRUE about customized patient medication packages? I. A patient med-pak is a package prepared by a pharmacist for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. II. The patient med-pak shall bear a label stating the name, strength, physical description or identification, and total quantity of each drug product contained. III. The name of the prescriber of each drug product.

Answer: All A patient med-pak is a package prepared by a pharmacist for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. The patient med-pak is so designed or each container is so labeled as to indicate the day and time, or period of time that the contents within each container are to be taken. The patient med-pak shall bear a label stating: (1). the name of the patient; (2). the unique identification number for the patient med-pak itself and a separate unique identification number for each of the prescription drug orders for each of the drug products contained therein; (3). the name, strength, physical description or identification, and total quantity of each drug product contained therein; (4). the directions for use and cautionary statements, if any, contained in the prescription drug order for each drug product contained therein; (5). if applicable, a warning of the potential harmful effect of combining any form of alcoholic beverage with any drug product contained therein; (6). any storage instructions or cautionary statements required by the official compendia; (7). the name of the prescriber of each drug product; (8). the name, address, and telephone number of the pharmacy; (9). the initials or an identification code of the dispensing pharmacist; and (10). any other information, statements, or warnings required for any of the drug products contained therein. (11). the date after which the prescription should not be used or beyond-use-date. Unless otherwise specified by the manufacturer, the beyond-use-date shall be one year from the date the med-pak is dispensed or the earliest manufacturer's expiration date for a product contained in the med-pak if it is less than one-year from the date dispensed. The beyond-use-date may be placed on the prescription label or on a flag label attached to the bottle. A beyond-use-date is not required on the label of a prescription dispensed to a person at the time of release from prison or jail if the prescription is for not more than a 10-day supply of medication; and (12). either on the prescription label or the written information accompanying the prescription, the statement "Do not flush unused medications or pour down a sink or drain." A drug product on a list developed by the Federal Food and Drug Administration of medicines recommended for disposal by flushing is not required to bear this statement.

A pharmacist who works for a health care facility or penal institution may not return a drug that: I. Has been compounded. II. Has less than 120 days until the expiration date or end of the shelf life. III. Appears on inspection to be adulterated.

Answer: All A pharmacist who worked for a health care facility may not return a drug that: (1). has been compounded; (2). appears on inspection to be adulterated; (3). requires refrigeration; or (4). has less than 120 days until the expiration date or end of the shelf life.

A pharmacist-intern may not: I. Present or identify himself/herself as a pharmacist. II. Sign or initial any document which is required to be signed or initialed by a pharmacist unless a preceptor cosigns the document. III. Independently supervise pharmacy technicians or pharmacy technician trainees.

Answer: All A pharmacist-intern may not: (1). present or identify himself/herself as a pharmacist; (2). sign or initial any document which is required to be signed or initialed by a pharmacist unless a preceptor cosigns the document; or (3). independently supervise pharmacy technicians or pharmacy technician trainees.

A pharmacy may not sell, purchase, trade or possess prescription drug samples, unless the: I. the pharmacy is owned by a charitable organization. II. the samples are for dispensing or provision at no charge to patients of health care entity. III. the pharmacy is a part of a health care entity which provides health care primarily to indigent or low income patients at no or reduced cost.

Answer: All A pharmacy may not sell, purchase, trade or possess prescription drug samples, unless the pharmacy meets all of the following conditions: (1). the pharmacy is owned by a charitable organization described in the Internal Revenue Code of 1986, or by a city, state or county government; (2). the pharmacy is a part of a health care entity which provides health care primarily to indigent or low income patients at no or reduced cost; (3). the samples are for dispensing or provision at no charge to patients of such health care entity; and (4). the samples are possessed in compliance with the federal Prescription Drug Marketing Act of 1987.

Which of the following is/are TRUE about Official Prescription Form? I. A person may not obtain an official prescription form unless the person is a practitioner as defined by Texas Pharmacy Law. II. Each official prescription form used to prescribe a Schedule II controlled substance must contain not more than one prescription on an official prescription form. III. The director shall issue official prescription forms to practitioners.

Answer: All A practitioner who prescribes a controlled substance listed in Schedule II shall record the prescription on an official prescription form or in an electronic prescription that includes the information required by this section. (b). Each official prescription form must be sequentially numbered. (c). The director shall issue official prescription forms to practitioners for a fee covering the actual cost of printing, processing, and mailing the forms at 100 a package. (d). A person may not obtain an official prescription form unless the person is a practitioner or an institutional practitioner. (e). Each official prescription form or electronic prescription used to prescribe a Schedule II controlled substance must contain: (1). information provided by the prescribing practitioner, including: (A). the date the prescription is issued; (B). the controlled substance prescribed; (C). the quantity of controlled substance prescribed, shown: (i). numerically, followed by the number written as a word, if the prescription is written; or (ii). numerically, if the prescription is electronic; (D). the intended use of the controlled substance or the diagnosis for which it is prescribed and the instructions for use of the substance; (E). the practitioner's name, address, and Federal Drug Enforcement Administration number issued for prescribing a controlled substance in this state; (F). the name, address, and date of birth or age of the person for whom the controlled substance is prescribed; and (G). if the prescription is issued to be filled at a later date under Section 481.074(d-1), the earliest date on which a pharmacy may fill the prescription; (2). information provided by the dispensing pharmacist, including the date the prescription is filled; and (3). for a written prescription, the signatures of the prescribing practitioner and the dispensing pharmacist or for an electronic prescription, the prescribing practitioner's electronic signature or other secure method of validation authorized by federal law. (f). Not more than one prescription may be recorded on an official prescription form.

Which of the following shall be required in a reference library of pharmacy? I. USPDI volume I II. AHFS Drug Information III. Basic antidote information and the telephone number of the nearest Regional Poison Control Center

Answer: All A reference library shall be maintained that includes the following in hard-copy or electronic format and that pharmacy personnel shall be capable of accessing at all times: (1). current copies of the following: (A). Texas Pharmacy Act and rules; (B). Texas Dangerous Drug Act and rules; (C). Texas Controlled Substances Act and regulations; and (D). Federal Controlled Substances Act and regulations (or official publication describing the requirements of the Federal Controlled Substances Act and regulations); (2). at least one current or updated reference from each of the following categories: (A). drug interactions. A reference text on drug interactions, such as Drug Interaction Facts. A separate reference is not required if other references maintained by the pharmacy contain drug interaction information including information needed to determine severity or significance of the interaction and appropriate recommendations or actions to be taken; (B). a general information reference text, such as: (i). Facts and Comparisons with current supplements; (ii). United States Pharmacopeia Dispensing Information Volume I (Drug Information for the Healthcare Provider); (iii). AHFS Drug Information with current supplements; (iv). Remington's Pharmaceutical Sciences; or (v). Clinical Pharmacology; (3). a current or updated reference on injectable drug products, such as Handbook of Injectable Drugs; (4). basic antidote information and the telephone number of the nearest regional poison control center; (5). metric-apothecary weight and measure conversion charts. (6). For nuclear pharmacy, a minimum of one text dealing with nuclear medicine science.

According to Texas State Pharmacy Law, a practitioner or institutional practitioner may not allow a patient, on the patient's release from the hospital, to possess a controlled substance prescribed by the practitioner unless: I. the controlled substance was dispensed under a medication order while the patient was admitted to the hospital. II. the controlled substance is in a properly labeled container. III. the patient possesses not more than a seven-day supply of the controlled substance.

Answer: All According to Texas State Pharmacy Law, a practitioner or institutional practitioner may not allow a patient, on the patient's release from the hospital, to possess a controlled substance prescribed by the practitioner unless: 1. the controlled substance was dispensed under a medication order while the patient was admitted to the hospital. 2. the controlled substance is in a properly labeled container. 3. the patient possesses not more than a seven-day supply of the controlled substance.

Which of the following shall require on a prescription of controlled substance signed by an advanced practice nurse? I. name, original signature and the identification number of the advanced practice nurse. II. name, address, telephone number of the supervising practitioner. III. address and telephone number of the clinic at which the prescription drug order was signed.

Answer: All All original written prescriptions carried out or signed by an advanced practice nurse or physician assistant in accordance with Subtitle B, Chapter 157, Occupations Code, shall bear: (1). the patient 's name and address; (2). the drug to be dispensed; (3). directions to the patient regarding the taking of the drug and the dosage; (4). the intended use of the drug, if appropriate; (5). the name, address, and telephone number of the physician; (6). the name, address, telephone number, and identification number of the registered nurse or physician assistant completing or signing the prescription drug order; (7). the date; and (8). the number of refills permitted. (9). address and telephone number of the clinic/hospital at which the prescription drug order was signed.

Which of the following information is/are TRUE about Drug Therapy Management by a Pharmacist under the written protocol of a physician? I. A pharmacist engaged in drug therapy management shall annually complete six hours of continuing education related to drug therapy offered by a provider approved by the Accreditation Council for Pharmacy Education (ACPE). II. A physician may delegate to a properly qualified and trained pharmacist acting under adequate physician supervision the performance of specific acts of drug therapy management authorized by the physician through the physician's order, standing medical order, standing delegation order, or other order or protocol. III. Every record required to be kept by the pharmacist and be available, for at least two years from the date of such record, for inspecting and copying by the board or its representative.

Answer: All Drug therapy management--The performance of specific acts by pharmacists as authorized by a physician through written protocol. Drug therapy management does not include the selection of drug products not prescribed by the physician, unless the drug product is named in the physician initiated protocol or the physician initiated record of deviation from a standing protocol. Drug therapy management may include the following: (A). collecting and reviewing patient drug use histories; (B). ordering or performing routine drug therapy related patient assessment procedures including temperature, pulse, and respiration; (C). ordering drug therapy related laboratory tests; (D). implementing or modifying drug therapy following diagnosis, initial patient assessment, and ordering of drug therapy by a physician as detailed in the protocol; or (E). any other drug therapy related act delegated by a physician. Written protocol--A physician's order, standing medical order, standing delegation order, or other order or protocol as defined by rule of the Texas Medical Board under the Medical Practice Act. (A). A written protocol must contain at a minimum the following: (i). a statement identifying the individual physician authorized to prescribe drugs and responsible for the delegation of drug therapy management; (ii). a statement identifying the individual pharmacist authorized to dispense drugs and to engage in drug therapy management as delegated by the physician; (iii). a statement identifying the types of drug therapy management decisions that the pharmacist is authorized to make which shall include: (I). a statement of the ailments or diseases involved, drugs, and types of drug therapy management authorized; and (II). a specific statement of the procedures, decision criteria, or plan the pharmacist shall follow when exercising drug therapy management authority. Pharmacist Training Requirements: (1). Initial requirements. A pharmacist shall maintain and provide to the Board within 24 hours of request a statement attesting to the fact that the pharmacist has within the last year: (A). completed at least six hours of continuing education related to drug therapy offered by a provider approved by the Accreditation Council for Pharmacy Education (ACPE); or (B). engaged in drug therapy management as allowed under previous laws or rules. A statement from the physician supervising the acts shall be sufficient documentation. (2). Continuing requirements. A pharmacist engaged in drug therapy management shall annually complete six hours of continuing education related to drug therapy offered by a provider approved by the Accreditation Council for Pharmacy Education (ACPE). (These hours may be applied towards the hours required for renewal of a license to practice pharmacy.) Every record required to be kept under this section shall be kept by the pharmacist and be available, for at least two years from the date of such record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement or regulatory agencies.

Which of the following SHALL NOT be performed by a pharmacy technician or pharmacy technician trainee working under the direct supervision of a licensed NUCLEAR PHARMACIST? I. interpreting and evaluating radioactive prescription drug orders. II. receiving verbal therapeutic prescription drug orders and reducing these orders to writing, either manually or electronically. III. selection of drug products.

Answer: All Duties which may only be performed by an authorized nuclear pharmacist are as follows: (A). receiving verbal therapeutic prescription drug orders and reducing these orders to writing, either manually or electronically; (B). receiving verbal, diagnostic prescription drug orders in instances where patient specificity is required for patient safety (e.g., radiolabeled blood products, radiolabeled antibodies) and reducing these orders to writing, either manually or electronically; (C). interpreting and evaluating radioactive prescription drug orders; (D). selection of drug products; and (E). performing the final check of the dispensed prescription before delivery to the patient to ensure that the radioactive prescription drug order has been dispensed accurately as prescribed.

What are requirement(s) to become a licensed nuclear pharmacist in Texas? I. An applicant shall be a pharmacist licensed by the board to practice pharmacy in Texas. II. An applicant shall provide written certification that he or she has current board certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties. III. Alternatively, an applicant shall provide written certification signed by a preceptor authorized nuclear pharmacist that the applicant has satisfactorily completed 700 hours in a structured educational nuclear pharmacy program.

Answer: All General qualifications for an authorized nuclear pharmacist are the following. A pharmacist shall: (i). meet minimal standards of training and experience in the handling of radioactive materials in accordance with the requirements of the Texas Regulations for Control of Radiation of the Radiation Control Program, Texas Department of State Health Services; (ii). be a pharmacist licensed by the board to practice pharmacy in Texas; and (iii). submit to the board either: (I). written certification that he or she has current board certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties; or (II). written certification signed by a preceptor authorized nuclear pharmacist that he or she has achieved a level of competency sufficient to independently operate as an authorized nuclear pharmacist and has satisfactorily completed 700 hours in a structured educational program consisting of both: (-a-). 200 hours of didactic training in a program accepted by the Radiation Control Program, Texas Department of State Health Services in the following areas: (-1-). radiation physics and instrumentation; (-2-). radiation protection; (-3-). mathematics pertaining to the use and measurement of radioactivity; (-4-). radiation biology; and (-5-). chemistry of radioactive material for medical use; and (-b-). 500 hours of supervised practical experience in a nuclear pharmacy involving the following: (-1-). shipping, receiving, and performing related radiation surveys; (-2-). using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides; (-3-). calculating, assaying, and safely preparing dosages for patients or human research subjects; (-4-). using administrative controls to avoid adverse medical events in the administration of radioactive material; and (-5-). using procedures to prevent or minimize contamination and using proper decontamination procedures.

In which of the following instances, a pharmacist has reasons to suspect that a prescription was authorized solely based on the results of a questionnaire and/or in the absence of a valid patient-practitioner relationship? I. the number of prescriptions authorized on a daily basis by the practitioner. II. the geographical distance between the practitioner and the patient. III. the manner in which the prescriptions are authorized by the practitioner or received by the pharmacy.

Answer: All If a pharmacist has reasons to suspect that a prescription was authorized solely based on the results of a questionnaire and/or in the absence of a documented patient evaluation including a physical examination, the pharmacist shall ascertain if that practitioner's standard of practice allows that practitioner to authorize a prescription under such circumstances. Reasons to suspect that a prescription may have been authorized in the absence of a valid patient-practitioner relationship, or in violation of the practitioner's standard of practice, include: (1). the number of prescriptions authorized on a daily basis by the practitioner; (2). a disproportionate number of patients of the practitioner receive controlled substances; (3). the manner in which the prescriptions are authorized by the practitioner or received by the pharmacy; (4). the geographical distance between the practitioner and the patient; (5). knowledge by the pharmacist that the prescription was issued solely based on answers to a questionnaire; or (6). knowledge by the pharmacist that the pharmacy he/she works for directly or indirectly participates in or is otherwise associated with an Internet site that markets prescription drugs to the public without requiring the patient to provide a valid prescription order from the patient's practitioner; (7). knowledge by the pharmacist that the patient has exhibited doctor-shopping or pharmacy-shopping tendencies. A pharmacist may dispense a prescription when a physician has not established a professional relationship with a patient if the prescription is for medications for: (A). sexually transmitted diseases for partners of the physician's established patient; or (B). a patient's family members if the patient has an illness determined by the Centers for Disease Control and Prevention, the World Health Organization, or the Governor's office to be pandemic.

In Texas, who may allow to fill a drug to an automated compounding or counting device? I. a pharmacist II. a certified pharmacy technician III. a pharmacy technician trainee

Answer: All If a pharmacy uses automated compounding or counting devices: (A). the pharmacy shall have a method to calibrate and verify the accuracy of the automated compounding or counting device and document the calibration and verification on a routine basis; (B). the devices may be loaded with bulk or unlabeled drugs only by a pharmacist, a pharmacy-intern, pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist; (C). the label of an automated compounding or counting device container shall indicate the brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor; (D). records of loading bulk or unlabeled drugs into an automated compounding or counting device shall be maintained to show: (i). name of the drug, strength, and dosage form; (ii). manufacturer or distributor; (iii). manufacturer's lot number; (iv). manufacturer's expiration date; (v). date of loading; (vi). name, initials, or electronic signature of the person loading the automated compounding or counting device; and (vii). signature or electronic signature of the responsible pharmacist.

Which of the following is/are TRUE when a patient has been admitted to the emergency room of a hospital and a controlled or dangerous drug to be supplied? I. During the times a pharmacist is on duty in the facility any prescription drugs supplied to an outpatient, including emergency department patients, may only be dispensed by a pharmacist. II. When a pharmacist is not on duty in the facility, only dangerous drugs listed on the emergency room drug list may be supplied. III. When a pharmacist is not on duty in the facility, dangerous drugs and/or controlled substances may only be supplied in prepackaged quantities not to exceed a 72-hour supply in suitable containers and appropriately prelabeled by the institutional pharmacy.

Answer: All If the patient has been admitted to the emergency room of a hospital and a controlled or dangerous drug to be supplied, the following is applicable. (1). During the times a pharmacist is on duty in the facility any prescription drugs supplied to an outpatient, including emergency department patients, may only be dispensed by a pharmacist. (2). When a pharmacist is not on duty in the facility, the following is applicable for supplying prescription drugs to be taken home by the patient for self-administration from the emergency room. If the patient has been admitted to the emergency room and assessed by a practitioner at the hospital, the following procedures shall be observed in supplying prescription drugs from the emergency room. (A). Dangerous drugs and/or controlled substances may only be supplied in accordance with the system of control and accountability for dangerous drugs and/or controlled substances administered or supplied from the emergency room; such system shall be developed and supervised by the pharmacist-in-charge or staff pharmacist designated by the pharmacist-in-charge. (B). Only dangerous drugs and/or controlled substances listed on the emergency room drug list may be supplied; such list shall be developed by the pharmacist-in-charge and the facility's emergency department committee (or like group or person responsible for policy in that department) and shall consist of dangerous drugs and/or controlled substances of the nature and type to meet the immediate needs of emergency room patients. (C). Dangerous drugs and/or controlled substances may only be supplied in prepackaged quantities not to exceed a 72-hour supply in suitable containers and appropriately prelabeled (including necessary auxiliary labels) by the institutional pharmacy. (D). At the time of delivery of the dangerous drugs and/or controlled substances, the practitioner or licensed nurse under the supervision of a practitioner shall appropriately complete the label with at least the following information: (i). name, address, and phone number of the facility; (ii). date supplied; (iii). name of practitioner; (iv). name of patient; (v). directions for use; (vi). brand name and strength of the dangerous drug or controlled substance; or if no brand name, then the generic name, strength, and the name of the manufacturer or distributor of the dangerous drug or controlled substance; (vii). quantity supplied; and (viii). unique identification number. (E). The practitioner, or a licensed nurse under the supervision of the practitioner, shall give the appropriately labeled, prepackaged drug to the patient and explain the correct use of the drug. (F). A perpetual record of dangerous drugs and/or controlled substances supplied from the emergency room shall be maintained in the emergency room. Such record shall include the following: (i). date supplied; (ii). practitioner's name; (iii). patient's name; (iv). brand name and strength of the dangerous drug or controlled substance; or if no brand name, then the generic name, strength, and the name of the manufacturer or distributor of the dangerous drug or controlled substance; (v). quantity supplied; and (vi). unique identification number. (G). The pharmacist-in-charge, or staff pharmacist designated by the pharmacist-in-charge, shall verify the correctness of this record at least once every seven days.

Faxing a prescription for Schedule II controlled drugs may serve as the original prescription only if: I. A Schedule II narcotic or nonnarcotic substance for a patient in a long-term care facility (LTCF). II. A Schedule II narcotic product to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion. III. A Schedule II narcotic substance for a patient with a medical diagnosis documenting a terminal illness.

Answer: All Normally, a C-II prescription drug order may be transmitted by the practitioner or the practitioner's agent, but not the patient or patient's agent, to a pharmacy via facsimile machine or equipment. The original written, signed prescription drug order must be presented by the patient to the pharmacist prior to the actual dispensing of the schedule II (C-II) drug. Faxing a prescription for Schedule II controlled drugs may serve as the original prescription only if: (A). a Schedule II narcotic or nonnarcotic substance for a patient in a long-term care facility (LTCF), and the practitioner notes on the prescription "LTCF patient"; (B). a Schedule II narcotic product to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion; or (C). a Schedule II narcotic substance for a patient with a medical diagnosis documenting a terminal illness or a patient enrolled in a hospice care program certified or paid for by Medicare under Title XVIII, Social Security Act (42 U.S.C. Section 1395 et seq.), as amended, or a hospice program that is licensed under Chapter 142, and the practitioner or the practitioner's agent notes on the prescription "terminally ill" or "hospice patient". After transmitting the prescription, the prescribing practitioner or the practitioner's agent: (A). writes across the face of the official prescription "VOID--sent by fax to (name and telephone number of receiving pharmacy)"; and (B). files the official prescription in the patient's medical records instead of delivering it to the patient.

An electronic transfer for non-controlled substances between pharmacies may be initiated by: I. a pharmacist II. a student-intern III. a pharmacy technician trainee

Answer: All Pharmacies electronically accessing the same prescription drug order records may electronically transfer prescription information if the following requirements are met: (A). The original prescription is voided and the following information is documented in the records of the transferring pharmacy: (i). the name, address, and if a controlled substance, the DEA registration number of the pharmacy to which such prescription is transferred; (ii). the name of the pharmacist or pharmacist intern receiving the prescription drug order information; and (iii). the date of the transfer. (B). Pharmacies not owned by the same person may electronically access the same prescription drug order records, provided the owner or chief executive officer of each pharmacy signs an agreement allowing access to such prescription drug order records. (C). An electronic transfer between pharmacies may be initiated by a pharmacist intern, pharmacy technician, or pharmacy technician trainee acting under the direct supervision of a pharmacist.

Pharmacist who enters into a written protocol with a physician to administer immunizations or vaccinations shall complete a course provided by an ACPE approved provider which: I. requires documentation by the pharmacist of current certification in the American Heart Association's Basic Cardiac Life Support for Health-Care Providers or its equivalent. II. is an evidence-based course which includes hands-on training in techniques for administering immunizations or vaccines. III. meets current Center for Disease Control training guidelines.

Answer: All Pharmacist who enter into a written protocol with a physician to administer immunizations or vaccinations shall: (1). complete a course provided by an ACPE approved provider which: (A). requires documentation by the pharmacist of current certification in the American Heart Association's Basic Cardiac Life Support for Health-Care Providers or its equivalent; (B). is an evidence-based course which: (i). includes study material; (ii). includes hands-on training in techniques for administering immunizations or vaccines; and (iii). requires testing with a passing score; and (C). meets current Center for Disease Control training guidelines and provides a minimum of 20 hours of instruction and experiential training in the following content areas: (i). standards for pediatric, adolescent, and adult immunization practices; (ii). basic immunology and vaccine protection; (iii). vaccine-preventable diseases; (iv). recommended immunization schedules (pediatric/adolescent/adult); (v). vaccine storage and management; (vi). informed consent; (vii). physiology and techniques for vaccine administration; (viii). pre and post-vaccine assessment and counseling; (ix). immunization record management; and (x). adverse events: (2). maintain documentation of: (A). completion of the initial course specified in paragraph (1) of this subsection; (B). 3 hours of continuing education every 2 years which are designed to maintain competency in the disease states, drugs, and administration of immunizations or vaccinations; and (C). current certification in the American Heart Association's Basic Cardiac Life Support for Health-Care Providers or its equivalent.

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.

Answer: All 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.

According to Texas 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. Ambulance Service II. Nurse practitioner III. Physician Assistants

Answer: All 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 Texas, only following mid level practitioners can either prescribe or administer or both, schedule controlled substances. 1. AS (Animal Shelters): Schedule II and III narcotics (sodium pentobarbital). 2. NP (Nurse Practitioner): Schedule III to V controlled substances prescribe and administer. Schedule II Prescribing and Ordering Only for Hospital/Hospice. 3. PA (Physician assistants): Schedule III to V controlled substances prescribe and administer. Schedule II Prescribing and Ordering Only for Hospital/Hospice. 4. AMB (Ambulance Service): Schedule II to V controlled substances. 5. OD (Optometrists): Schedule III to V controlled substances (prescribe and administer). Schedule II controlled substances (administer only).

In which of the following situations may the board specify conditions under which the pharmacist may administer medication, including immunizations or vaccinations? I. When a licensed health care provider authorized to administer the medication is not reasonably available to administer the medication. II. When failure to administer the medication might result in a significant delay or interruption of a critical phase of therapy. III. A pharmacist administers an immunization or vaccination under a physician's written protocol.

Answer: All The board shall specify following conditions under which a pharmacist may administer medication, including an immunization and vaccination, these are: (1). a licensed health care provider authorized to administer the medication is not reasonably available to administer the medication; (2). failure to administer the medication, other than an immunization or vaccination, might result in a significant delay or interruption of a critical phase of drug therapy; (3). the pharmacist possesses the necessary skill, education, and certification as specified by the board to administer the medication; (4). within a reasonable time after administering medication, the pharmacist notifies the licensed health care provider responsible for the patient's care that the medication was administered; (5). the pharmacist may not administer medication to a patient at the patient's residence, except at a licensed nursing home or hospital; (6). the pharmacist administers an immunization or vaccination under a physician's written protocol and meets the standards established by the board and (7). the authority of a pharmacist to administer medication may not be delegated.

The incoming pharmacist-in-charge shall be responsible for notifying the board within 10 days in writing on a form provided by the board, that a change of pharmacist-in-charge has occurred. This notification shall include which of the following? I. the name and license number of the departing pharmacist-in-charge. II. the name and license number of the incoming pharmacist-in-charge. III. the date the incoming pharmacist-in-charge became the pharmacist-in-charge.

Answer: All The incoming pharmacist-in-charge shall be responsible for notifying the board within 10 days in writing on a form provided by the board, that a change of pharmacist-in-charge has occurred. The notification shall include the following: (i). the name and license number of the departing pharmacist-in-charge; (ii). the name and license number of the incoming pharmacist-in-charge; (iii). the date the incoming pharmacist-in-charge became the pharmacist-in-charge; and (iv). a statement signed by the incoming pharmacist-in-charge attesting that: (I). an inventory has been conducted by the departing and incoming pharmacists-in-charge; if the inventory was not taken by both pharmacists, the statement shall provide an explanation; and (II). the incoming pharmacist-in-charge has read and understands the laws and rules relating to this class of pharmacy.

The owner of a pharmacy shall notify the board in writing within 10 days of a change of any managing officer of a partnership or corporation which owns a pharmacy. The written notification shall include the effective date of such change and the following information for all managing officers: I. name and title II. home address III. social security number

Answer: All The owner of a pharmacy shall notify the board in writing within 10 days of a change of any managing officer of a partnership or corporation which owns a pharmacy. The written notification shall include the effective date of such change and the following information for all managing officers: (A). name and title; (B). home address and telephone number; (C). date of birth; and (D). a copy of social security card or other official document showing the social security number as approved by the board; however, if an individual is unable to obtain a social security number, an individual taxpayer identification number may be provided in lieu of a social security number along with documentation indicating why the individual is unable to obtain a social security number; and (E). a copy of current driver's license, state issued photo identification card, or passport. (2). For purposes of this subsection, managing officers are defined as the top four executive officers, including the corporate officer in charge of pharmacy operations, who are designated by the partnership or corporation to be jointly responsible for the legal operation of the pharmacy.

If controlled substances, dangerous drugs, or DEA order forms are lost or destroyed in the disaster, the pharmacy shall notify the: I. DEA II. Texas State Board of Pharmacy III. DPS

Answer: All The theft or significant loss of any controlled substance by a pharmacy shall be reported in writing to the board immediately on discovery of such theft or loss. If controlled substances, dangerous drugs, or Drug Enforcement Administration (DEA) order forms are lost or destroyed in the disaster, the pharmacy shall: (I). notify the DEA, Department of Public Safety (DPS), and Texas State Board of Pharmacy (board) of the loss of the controlled substances or order forms. A pharmacy shall be in compliance with this section by submitting to each of these agencies a copy of the DEA's report of theft or loss of controlled substances, DEA Form-106, immediately on discovery of the loss; and (II). notify the Texas State Board of Pharmacy in writing of the loss of the dangerous drugs by submitting a list of the dangerous drugs lost. (ii). If the extent of the loss of controlled substances or dangerous drugs is not able to be determined, the pharmacy shall: (I). take a new, complete inventory of all remaining drugs specified in §291.17(c) of this title (relating to Inventory Requirements); (II). submit to DEA and DPS a statement attesting that the loss of controlled substances is indeterminable and that a new, complete inventory of all remaining controlled substances was conducted and state the date of such inventory; and (III). submit to the board a statement attesting that the loss of controlled substances and dangerous drugs is indeterminable and that a new, complete inventory of the drugs specified in §291.17(c) of this title was conducted and state the date of such inventory.

Which of the following should be part of a patient's counseling? I. The name and description of the drug. II. Techniques for self-monitoring of therapy. III. Action to be taken in the event of a missed dose.

Answer: All To optimize drug therapy, a pharmacist shall counsel the patient or patient's agent regarding: 1. the name and description of the drug or device. 2. dosage form, dosage, route of administration, and duration of drug therapy. 3. special direction and precautions for preparation, administration, and use by the patient. 4. common severe side or adverse effects or interactions and therapeutic contraindications that may occur with the therapy. 5. techniques for self-monitoring of drug therapy. 6. proper storage of medication. 7. refill information. 8. action to be taken in the event of a missed dose. (B). Such communication shall be: (i). provided to new and existing patients of a pharmacy with each new prescription drug order. A new prescription drug order is one that has not been dispensed by the pharmacy to the patient in the same dosage and strength within the last year; (ii). provided for any prescription drug order dispensed by the pharmacy on the request of the patient or patient's agent; (iii). communicated orally in person unless the patient or patient's agent is not at the pharmacy or a specific communication barrier prohibits such oral communication; (iv). documented by recording the initials or identification code of the pharmacist providing the counseling in the prescription dispensing record as follows: (I). on the original hard-copy prescription, provided the counseling pharmacist clearly records his or her initials on the prescription for the purpose of identifying who provided the counseling; (II). in the pharmacy's data processing system; (III). in an electronic logbook; or (IV). in a hard-copy log; and (v). reinforced with written information relevant to the prescription and provided to the patient or patient's agent.

To qualify for a pharmacy license, the applicant must submit an application including which of the following information? I. the name and address of new pharmacy. II. a copy of lease agreement of pharmacy. III. name and address of malpractice insurance carrier.

Answer: All To qualify for a pharmacy license, the applicant must submit an application including the following information: (1). name and address of pharmacy; (2). type of ownership; (3). names, addresses, phone numbers, dates of birth, and social security numbers; however, if an individual is unable to obtain a social security number, an individual taxpayer identification number may be provided in lieu of a social security number along with documentation indicating why the individual is unable to obtain a social security number, of all owners; if a partnership or corporation, for all managing officers, the name, title, addresses, phone numbers, dates of birth, and social security numbers; however, if an individual is unable to obtain a social security number, an individual taxpayer identification number may be provided in lieu of a social security number along with documentation indicating why the individual is unable to obtain a social security number; (4). name and license number of the pharmacist-in-charge and of other pharmacists employed by the pharmacy; (5). anticipated date of opening and hours of operation; (6). copy of lease agreement or if the location of the pharmacy is owned by the applicant, a notarized statement certifying such location ownership; (7). the signature of the pharmacist-in-charge; (8). the notarized signature of the owner, or if the pharmacy is owned by a partnership or corporation, the notarized signature of an owner or managing officer; (9). federal tax ID number of the owner; (10). description of business services that will be offered; (11). name and address of malpractice insurance carrier or statement that the business will be self-insured; (12). the certificate of authority, if applicant is an out-of-state corporation; (13). the articles of incorporation, if the applicant is a corporation; (14). a current Texas Franchise Tax Certificate of Good Standing; and (15). any other information requested on the application.

When a pharmacy changes location and/or name, which of the following is/are applicable? I. A new completed pharmacy application containing required information must be filed with the board not later than 30 days before the date of the change of location of the pharmacy. II. An amended license reflecting the new location and/or name of the pharmacy will be issued by the board. III. At least 14 days prior to the change of location of a pharmacy that dispenses prescription drug orders, the pharmacist-in-charge shall post a sign in a conspicuous place indicating that the pharmacy is changing locations.

Answer: All When a pharmacy changes location and/or name, the following is applicable. (A). A new completed pharmacy application containing required information must be filed with the board not later than 30 days before the date of the change of location of the pharmacy. (B). The previously issued license must be returned to the board office. (C). An amended license reflecting the new location and/or name of the pharmacy will be issued by the board; and (D). A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for issuance of the amended license. (2). At least 14 days prior to the change of location of a pharmacy that dispenses prescription drug orders, the pharmacist-in-charge shall post a sign in a conspicuous place indicating that the pharmacy is changing locations. Such sign shall be in the front of the prescription department and at all public entrance doors to the pharmacy and shall indicate the date the pharmacy is changing locations. (3). Disasters, accidents, and emergencies which require the pharmacy to change location shall be immediately reported to the board. If a pharmacy changes location suddenly due to disasters, accidents, or other emergency circumstances and the pharmacist-in-charge cannot provide notification 14 days prior to the change of location, the pharmacist-in-charge shall comply with the provisions of paragraph (2) of this subsection as far in advance of the change of location as allowed by the circumstances.

What is the maximum amount of Robitussin A/C that can be dispensed without a prescription to a given purchaser within a 48-hour period? a. 240 cc b. 120 cc c. 60 cc d. Can't be dispensed

Answer: Can't be dispensed Schedule V controlled substances containing codeine, dihydrocodeine, or any of the salts of codeine or dihydrocodeine may not be distributed without a prescription drug order from a practitioner, [Texas Administrative Code Title 22, Part 15, Chapter 291, Subchapter B, 291.33(f)(3)(A)]

A patient comes to a pharmacy and asks for refill on one of his prescription medications. The prescription was filled 30 days ago. The original prescription reads: Atenolol 50 mg, 1 po qd x 30 days, 5 refills. On the back of the original prescription, the pharmacist has found the initial of the dispensing pharmacist and the date on which dispensing occurs. What would be the dispensed quantities for the requested refill? a. Cannot be refilled b. 30 tablets c. 150 tablets d. 42 tablets

Answer: Cannot be refilled Each time a prescription drug order is refilled, a record of such refill shall be made: (i). on the back of the prescription by recording the date of dispensing, the written initials or identification code of the dispensing pharmacist, the initials or identification code of the pharmacy technician or pharmacy technician trainee preparing the prescription label, if applicable, and the amount dispensed. If the pharmacist merely initials and dates the back of the prescription drug order, he or she shall be deemed to have dispensed a refill for the full face amount of the prescription drug order.

A patient visits to a pharmacy and asks for a refill on his blood pressure maintenance medication. Upon reviewing, the pharmacist revealed that the original prescription for the requested refill was filled by another pharmacy. The patient has presented an empty prescription container which shows all the required information regarding originally issued pharmacy and prescribing physician. The pharmacist tries to contact the pharmacy and prescribing physician without any success. Under these circumstances, which of the following is TRUE?

Answer: Fill a 3-day supply. If a pharmacist is unable to contact the prescribing practitioner after a reasonable effort, a pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided: (i). failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering; (ii). the quantity of prescription drug dispensed does not exceed a 72-hour supply; (iii). the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills; (iv). the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time; (v). the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection; (vi). the pharmacist affixes a label to the dispensing container as specified in §291.33(c)(7) of this title; and (vii). if the prescription was initially filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided: (I). the patient has the prescription container, label, receipt or other documentation from the other pharmacy which contains the essential information; (II). after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription; (III). the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of clause (i) of this subparagraph; and (IV). the pharmacist complies with the requirements of clauses (ii) - (vi) of this subparagraph.

A prescription for Zyprexa 10 mg is presented by an adult patient to a pharmacist. The prescription reads: Zyprexa 10 mg (1 tablet by mouth daily x 30 days x 2 refills). The patient has requested the pharmacist to fill a whole 90-day supply. What shall the pharmacist do?

Answer: Fill a 30-day supply. Accelerated refills. In accordance with §562.0545 of the Act, a pharmacist may dispense up to a 90-day supply of a dangerous drug pursuant to a valid prescription that specifies the dispensing of a lesser amount followed by periodic refills of that amount if: (A). the total quantity of dosage units dispensed does not exceed the total quantity of dosage units authorized by the prescriber on the original prescription, including refills; (B). the patient consents to the dispensing of up to a 90-day supply and the physician has been notified electronically or by telephone; (C). the physician has not specified on the prescription that dispensing the prescription in an initial amount followed by periodic refills is medically necessary; (D). the dangerous drug is not a psychotropic drug used to treat mental or psychiatric conditions (e.g. Zyprexa); and (E). the patient is at least 18 years of age.

A person whose license has been revoked by the Board may apply for removal of restriction after the: a. First anniversary b. Second anniversary c. Third anniversary d. First six months

Answer: First anniversary A person whose pharmacy license, license to practice pharmacy, or pharmacy technician registration in this state has been revoked or restricted, whether voluntarily or by board action, may, after the first anniversary of the effective date of the revocation or restriction, petition the board for reinstatement or removal of the restriction of the license or registration. (1). The petition must be in writing and in the form prescribed by the board. (2). A person petitioning for reinstatement or removal of a restriction has the burden of proof.

Any pharmacy that uses a centralized recordkeeping system may maintain which of the following data at a central location? I. financial data of pharmacy II. controlled substances inventories records of pharmacy III. executed DEA 222 order forms of pharmacy

Answer: I Any pharmacy that uses a centralized recordkeeping system for invoices and financial data shall comply with the following procedures. (1). Invoices and financial data for controlled and dangerous substances may be maintained at a central location provided the following conditions are met. (A). Prior to the initiation of central recordkeeping, the pharmacy submits written notification by registered or certified mail to the divisional director of the Drug Enforcement Administration, and submits a copy of this written notification to the Texas State Board of Pharmacy. Unless the registrant is informed by the divisional director of the Drug Enforcement Administration that permission to keep central records is denied, the pharmacy may maintain central records commencing 14 days after receipt of notification by the divisional director. (B). The pharmacy maintains a copy of the notification required in subparagraph (A) of this paragraph. (C). The records to be maintained at the central record location SHALL NOT include executed DEA order forms, prescription drug orders, or controlled substance inventories, which shall be maintained at the pharmacy.

If a pharmacist does not have Gengraf capsules in stock to refill the prescription, and if the practitioner is unavailable to give authorization, the pharmacist may dispense Gengraf oral solution provided that before dispensing the pharmacist: I. notifies and receives consent from the patient, at the time the prescription is dispensed, to substitute the prescribed drug product. II. notifies the prescribing practitioner of the drug product substitution orally or electronically at the earliest reasonable time, but not later than 24 hours after dispensing the prescription. III. prohibited to interchange Immunosuppressant drugs under the Texas Pharmacy Law.

Answer: I & II "Interchange" means the substitution of one version of the same immunosuppressant drug, including a generic version for the prescribed brand, a brand version for the prescribed generic version, a generic version by one manufacturer for a generic version by a different manufacturer, a different formulation of the prescribed immunosuppressant drug, or a different immunosuppressant drug for the immunosuppressant drug originally prescribed. A pharmacist may not interchange an immunosuppressant drug or formulation of an immunosuppressant drug, brand or generic, for the treatment of a patient following a transplant without prior consent to the interchange from the prescribing practitioner. In case, if a pharmacist does not have the same drug product by the same manufacturer in stock to refill the prescription, or if the practitioner is unavailable to give authorization, the pharmacist may dispense a drug product that is generically equivalent if the pharmacist, before dispensing the generally equivalent drug product: (1). notifies and receives consent from the patient, at the time the prescription is dispensed, to substitute the prescribed drug product; and (2). notifies the prescribing practitioner of the drug product substitution orally or electronically at the earliest reasonable time, but not later than 24 hours after dispensing the prescription. Similarly, a prescription for a narrow therapeutic index drug may be refilled only by using the same drug product by the same manufacturer that the pharmacist last dispensed under the prescription, unless otherwise agreed to by the prescribing practitioner. If a pharmacist does not have the same drug product by the same manufacturer in stock to refill the prescription, the pharmacist may dispense a drug product that is generically equivalent if the pharmacist, before dispensing the generically equivalent drug product, notifies: (1). the patient, at the time the prescription is dispensed, that a substitution of the prescribed drug product has been made; and (2). the prescribing practitioner of the drug product substitution by telephone, facsimile, or mail, at the earliest reasonable time, but not later than 72 hours after dispensing the prescription.

The label of a prepackaged drug shall include at minimum: I. the brand name and strength of drug II. the facility's lot number III. the name of manufacturer or distributor

Answer: I & II (1). Drugs may be prepackaged in quantities suitable for internal distribution only by a pharmacist; a pharmacy-intern, pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist. (2). The label of a prepackaged unit shall indicate: (A). brand name and strength of the drug; or if NO BRAND NAME, then the generic name, strength, and name of the manufacturer or distributor; (B). facility's lot number; (C). expiration date; and (D). quantity of the drug, if the quantity is greater than one. (3). Records of prepackaging shall be maintained to show: (A). name of the drug, strength, and dosage form; (B). facility's lot number; (C). manufacturer or distributor; (D). manufacturer's lot number; (E). expiration date; (F). quantity per prepackaged unit; (G). number of prepackaged units; (H). date packaged; (I). name, initials, or electronic signature of the prepacker; and (J). signature, or electronic signature of the responsible pharmacist. (4). Stock packages, repackaged units, and control records shall be quarantined together until checked/released by the pharmacist.

Who may request the prescription not to be dispensed in a child-resistant container? I. a patient II. a prescriber III. a pharmacist

Answer: I & II (A). A drug dispensed pursuant to a prescription drug order shall be dispensed in a child-resistant container unless: (i). the patient or the practitioner requests the prescription not be dispensed in a child-resistant container; or (ii). the product is exempted from requirements of the Poison Prevention Packaging Act of 1970.

Which of the following information is/are TRUE about dispensing of drugs at a remote pharmacy site? I. Drugs shall only be dispensed at a remote site through an automated pharmacy system after receipt of an original prescription drug order by a pharmacist at the provider pharmacy. II. A pharmacist at the provider pharmacy shall control all operations of the automated pharmacy system and approve the release of the initial dose of a prescription drug order. III. A pharmacist at the remote pharmacy shall conduct a drug regimen review before dispensing the drug.

Answer: I & II (A). Application for permission to provide pharmacy services using an automated pharmacy system: (i). A Class A or Class C Pharmacy shall make application to the board to provide remote pharmacy services using an automated pharmacy system. The application shall contain an affidavit with the notarized signatures of the pharmacist-in-charge, and the medical director or the person responsible for the on-site operation of the facility (e.g., administrator, chief operating officer, owner, chief executive officer), and include the following: (I). the name, address, and license number of the provider pharmacy; (II). name and address of the facility where the remote pharmacy services will be provided; (III). a statement indicating that the provider pharmacy and the facility have entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract or agreement in compliance with federal and state laws and regulations; and (IV). documentation that the automated pharmacy system is located where medications are administered by license healthcare professionals and is: (-a-). a facility regulated under Chapter 142, 242, 247, or 252, Health and Safety Code; or (-b-). a jail or prison, operated by the State of Texas or local government. (ii). Such application shall be resubmitted every two years in conjunction with the application for renewal of the provider pharmacy's license. The renewal petition shall contain the documentation required in clause (i) of this subparagraph except the notarized signature of the medical director or the person responsible for the on-site operation of the facility (e.g., administrator, chief operating officer, owner, chief executive officer) is not required. (iii). Upon approval of the application, the provider pharmacy will be sent a certificate which must be displayed at the remote site. (D). Prescription dispensing and delivery: (i). Drugs shall only be dispensed at a remote site through an automated pharmacy system after receipt of an original prescription drug order by a pharmacist at the provider pharmacy in a manner authorized by §291.34(b) of this title. (ii). A pharmacist at the provider pharmacy shall control all operations of the automated pharmacy system and approve the release of the initial dose of a prescription drug order. Subsequent doses from an approved prescription drug order may be removed from the automated medication system after this initial approval. Any change made in the prescription drug order shall require a new approval by a pharmacist to release the drug. (iii). A pharmacist at the provider pharmacy (not rempte pharmacy) shall conduct a drug regimen review as specified in §291.33(c) of this title prior to releasing a prescription drug order to the automated pharmacy system. (iv). Drugs dispensed by the provider pharmacy through an automated pharmacy system shall comply with the labeling or labeling alternatives specified in §291.33(c) of this title. (v). An automated pharmacy system used to meet the emergency medication needs for residents of a remote site must comply with the requirements for emergency medication kits in subsection (b) of this section. (E). Drugs: (i). Drugs for use in an automated pharmacy system shall be packaged in the original manufacturer's container or be prepackaged in the provider pharmacy and labeled in compliance with the board's prepackaging requirements for the class of pharmacy. (ii). Drugs dispensed from the automated pharmacy system may be returned to the pharmacy for reuse provided the drugs are in sealed, tamper evident packaging which has not been opened.

During the time a pharmacist is absent from the prescription department, only pharmacy technicians who have completed the pharmacy's training program may: I. initiate and receive refill authorization requests. II. enter prescription data into a data processing system. III. No act shall be performed in the absence of a pharmacist.

Answer: I & II (ii). During the time a pharmacist is absent from the prescription department, only pharmacy technicians who have completed the pharmacy's training program may perform the following duties, provided a pharmacist verifies the accuracy of all acts, tasks, and functions performed by the pharmacy technicians prior to delivery of the prescription to the patient or the patient's agent: (I). initiating and receiving refill authorization requests; (II). entering prescription data into a data processing system; (III). taking a stock bottle from the shelf for a prescription; (IV). preparing and packaging prescription drug orders (i.e., counting tablets/capsules, measuring liquids and placing them in the prescription container); (V). affixing prescription labels and auxiliary labels to the prescription container; and (VI). prepackaging and labeling prepackaged drugs. (iii) Upon return to the prescription department, the pharmacist shall: (I). conduct a drug regimen review as specified in subsection (c)(2) of this section; and (II). verify the accuracy of all acts, tasks, and functions performed by the pharmacy technicians prior to delivery of the prescription to the patient or the patient's agent.

Which of the following is/are TRUE about OTC sale of a product containing ephedrine? I. The person making the purchase shall display a driver's license or other form of government-issued identification containing the person's photograph. II. The person making the purchase shall sign for the purchase. III. The person making the purchase shall be at least 18 years or older.

Answer: I & II A business establishment that engages in over-the-counter sales of products containing ephedrine, pseudoephedrine, or norpseudoephedrine shall: (1). if the establishment operates a pharmacy licensed by the Texas State Board of Pharmacy, maintain those products: (A). behind the pharmacy counter; or (B). in a locked case within 30 feet and in a direct line of sight from a pharmacy counter staffed by an employee of the establishment; or (2). if the establishment does not operate a pharmacy licensed by the Texas State Board of Pharmacy, maintain those products: (A). behind a sales counter; or (B). in a locked case within 30 feet and in a direct line of sight from a sales counter continuously staffed by an employee of the establishment. Before completing an over-the-counter sale of a product containing ephedrine, pseudoephedrine, or norpseudoephedrine, a business establishment that engages in those sales shall: (1). require the person making the purchase to: (A). display a driver 's license or other form of government-issued identification containing the person 's photograph and indicating that the person is 16 years of age or older; and (B). sign for the purchase; (2). make a record of the sale, including the name and date of birth of the person making the purchase, the address of the purchaser, the date and time of the purchase, the type of identification displayed by the person and the identification number, and the item and number of grams purchased; and (3). transmit the record of sale as required by Section 486.0141. (b). business establishment may not sell to a person who makes over-the-counter purchases of one or more products containing ephedrine, pseudoephedrine, or norpseudoephedrine: (1). within any calendar day, more than 3.6 grams of ephedrine, pseudoephedrine, norpseudoephedrine, or a combination of those substances; and (2). within any 30-day period, more than 9 grams of ephedrine, pseudoephedrine, norpseudoephedrine, or a combination of those substances.

Who may accept a verbal prescription order for a dangerous drug or a controlled substance from a practitioner's designated agent? I. Licensed pharmacist II. Registered pharmacist-intern III. Qualified pharmacy technician

Answer: I & II A verbal prescription drug order for a dangerous drug or a controlled substance from a practitioner or a practitioner's designated agent may only be received by a pharmacist or a pharmacist-intern under the direct supervision of a pharmacist.

Which of the following is/are TRUE about an original ELECTRONICALLY transmitted prescription? I. Date the prescription drug order was electronically transmitted to the pharmacy. II. The date of issuance of the prescription. III. If transmitted by a designated agent, the full name and signature of the designated agent.

Answer: I & II All original prescription drug orders shall bear: (A). All original prescriptions shall bear: (i). name of the patient, or if such drug is for an animal, the species of such animal and the name of the owner; (ii). address of the patient, provided, however, a prescription for a dangerous drug is not required to bear the address of the patient if such address is readily retrievable on another appropriate, uniformly maintained pharmacy record, such as medication records; (iii). name, address and telephone number of the practitioner at the practitioner's usual place of business, legibly printed or stamped and if for a controlled substance, the DEA registration number of the practitioner; (iv). name and strength of the drug prescribed; (v). quantity prescribed numerically and if for a controlled substance: (I). numerically, followed by the number written as a word, if the prescription is written; (II). numerically, if the prescription is electronic; or (III). if the prescription is communicated orally or telephonically, as transcribed by the receiving pharmacist; (vi). directions for use; (vii). intended use for the drug unless the practitioner determines the furnishing of this information is not in the best interest of the patient; (viii). date of issuance; (ix). if a faxed prescription: (I). a statement that indicates that the prescription has been faxed (e.g., Faxed to); and (II). if transmitted by a designated agent, the name of the designated agent; (x). if electronically transmitted: (I). the date the prescription drug order was electronically transmitted to the pharmacy, if different from the date of issuance of the prescription; and (II). if transmitted by a designated agent, the name of the designated agent (SIGNATURE NOT REQUIRED).

For a pharmacy utilizing Centralized Prescription Dispensing system, which of the following shall be placed on the dispensing container? I. the name and address of the outsourcing pharmacy. II. a unique identifier of the central fill pharmacy. III. the name and address of the central fill pharmacy.

Answer: I & II Centralized prescription drug or medication order processing--the processing of a prescription drug or medication orders by a Class A, Class C, or Class E pharmacy on behalf of another pharmacy, a health care provider, or a payor. A Class A, Class C, or Class E Pharmacy may outsource prescription drug or medication order processing to another Class A, Class C, or Class E pharmacy provided the pharmacies: (i). have: (I). the same owner; or (II). entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations; and (ii). share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to process a non-dispensing function. Notifications to patients. (A). A pharmacy that outsources prescription dispensing to another pharmacy shall: (i). prior to outsourcing the prescription: (I). notify patients that their prescription may be outsourced to another pharmacy; and (II). give the name of that pharmacy or if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies may dispense the prescription, the patient shall be notified of this fact. Such notification may be provided through a one-time written notice to the patient or through use of a sign in the pharmacy; and (ii). if the prescription is delivered directly to the patient by the dispensing pharmacy and not returned to the requesting pharmacy, place on the prescription container or on a separate sheet delivered with the prescription container, in both English and Spanish, the local, and if applicable, the toll-free telephone number of the pharmacy and the statement: "Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at (insert the pharmacy's local and toll-free telephone numbers)." Prescription Labeling: The central fill pharmacy shall place on the prescription label, a. the name and address of the outsourcing pharmacy and a unique identifier (i.e., the central fill pharmacy's DEA registration number or, if the pharmacy does not have a DEA registration number, the central fill pharmacy's Texas license number) indicating that the prescription was dispensed by the central fill pharmacy; and b. comply with all other labeling requirements in §291.33 of this title.

Which of the following is/are TRUE when a pharmacist leaves the prescription department for short periods of time without closing the prescription department? I. the pharmacist may leave the prescription department for short periods of time without closing the prescription department if at least one pharmacy technician remains in the prescription department. II. the pharmacist may leave the prescription department for short periods of time without closing the prescription department if the pharmacist remains on-site at the licensed location of the pharmacy and is immediately available. III. It is NOT allowed under Texas State Pharmacy Law.

Answer: I & II If a pharmacy is staffed by only one pharmacist, the pharmacist may leave the prescription department for short periods of time without closing the prescription department and removing pharmacy technicians, pharmacy technician trainees, and other pharmacy personnel from the prescription department provided the following conditions are met: (I). at least one pharmacy technician remains in the prescription department; (II). the pharmacist remains on-site at the licensed location of the pharmacy and is immediately available; (III). the pharmacist reasonably believes that the security of the prescription department will be maintained in his or her absence. If in the professional judgment of the pharmacist, the pharmacist determines that the prescription department should close during his or her absence, then the pharmacist shall close the prescription department and remove the pharmacy technicians, pharmacy technician trainees, and other pharmacy personnel from the prescription department during his or her absence; and (IV). a notice is posted which includes the following information: (-a-). the pharmacist is on a break and the time the pharmacist will return; and (-b-). pharmacy technicians may begin the processing of prescription drug orders or refills brought in during the pharmacist's absence, but the prescription or refill may not be delivered to the patient or the patient's agent until the pharmacist verifies the accuracy of the prescription.

A pharmacist is conducting an inventory for Provigil. Which of the following shall be applied? I. An exact count is required. II. An estimate count is required if the drug is available in 100-tablet manufacturer bottle. III. An exact count is required if the drug is available in 1500-tablet manufacturer bottle. IV. It is not a controlled substance therefore no controlled-substance inventory is required.

Answer: II & III In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the prescription drug outlet shall do as follows: (1). If the drug is a schedule II drug, an exact count of the contents shall be made. (2). If the substance is listed in schedule III, IV, or V, and estimated count of the measure of the contents may be made, unless the container holds more than 1,000 tablets or capsules, in which case an exact count of the contents must be made. Modafinil (Provigil) is a wakefulness-promoting agent for oral administration. It is a schedule IV controlled substance. It is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder.

In a health care facility with a full time pharmacist, if a practitioner orders a drug for administration to a patient residing in the facility when the pharmacy is closed, which of the following can be TRUE? I. Prescription drugs only in sufficient quantities for immediate therapeutic needs may be removed from the pharmacy. II. Only a designated licensed nurse or practitioner may remove such drugs. III. The pharmacist shall verify the withdrawal and perform a drug regimen review within 24 hours of such withdrawal.

Answer: I & II In a health care facility with a full time pharmacist, if a practitioner orders a drug for administration to a patient residing in the facility when the pharmacy is closed, the following is applicable: (i). Prescription drugs and devices only in sufficient quantities for immediate therapeutic needs may be removed from the institutional pharmacy. (ii). Only a designated licensed nurse or practitioner may remove such drugs and devices. (iii). A record shall be made at the time of withdrawal by the authorized person removing the drugs and devices. The record shall contain the following information: (I). name of patient; (II). name of device or drug, strength, and dosage form; (III). dose prescribed; (IV). quantity taken; (V). time and date; and (VI). signature (first initial and last name or full signature) or electronic signature of person making withdrawal. (iv). The original or direct copy of the medication order may substitute for such record, providing the medication order meets all the requirements of clause (iii) of this subparagraph. (v). The pharmacist shall verify the withdrawal of drugs from the pharmacy and perform a drug regimen review as specified in subsection (g)(1)(B) of this section as soon as practical, but in no event more than 72 hours (Not 24 hours) from the time of such withdrawal. In facilities with a part-time or consultant pharmacist, if a practitioner orders a drug for administration to a bona fide patient of the facility when the pharmacist is not on duty, or when the pharmacy is closed, the following is applicable. (i). Prescription drugs and devices only in sufficient quantities for therapeutic needs may be removed from the institutional pharmacy. (ii). Only a designated licensed nurse or practitioner may remove such drugs and devices. (iii). A record shall be made at the time of withdrawal by the authorized person removing the drugs and devices; the record shall meet the same requirements as specified in subparagraph (A)(iii) and (iv) of this paragraph. (iv). The pharmacist shall verify the withdrawal of drugs from the pharmacy and perform a drug regimen review as specified in subsection (g)(1)(B) of this section after a reasonable interval, but in no event may such interval exceed seven days.

Which of the following information is/are TRUE about administering immunizations or vaccinations? I. Pharmacists may only administer immunizations or vaccinations pursuant to a written protocol from a physician authorizing the administration. II. Pharmacists may administer immunizations or vaccinations to a patient under 14 years of age only upon a referral from a physician who has an established physician-patient relationship with each patient. III. A pharmacist may administer an INFLUENZA vaccination to a patient over 3 years of age without an established physician-patient relationship.

Answer: I & II Pharmacists involved in the administration of immunizations or vaccinations under their license to practice pharmacy shall meet the following restrictions and requirements. (1). Pharmacists may only administer immunizations or vaccinations pursuant to a written protocol from a physician authorizing the administration. (2). Pharmacists may administer immunizations or vaccinations to a patient under 14 years of age only upon a referral from a physician who has an established physician-patient relationship with each patient. However, a pharmacist may administer an influenza vaccination to a patient over seven years of age without an established physician-patient relationship. Every record, including notifications, required to be made under this section shall be kept by the pharmacist administering the immunization or vaccination and by the pharmacy when in legal possession of the drugs administered. Such records shall be available for at least two years from the date of such record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement or regulatory agencies.

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.

Answer: I & II 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.

Which of the following is/are considered to be (an) approved program(s) for continuing education requirements? I. ACPE II. CME-1 III. ARSD

Answer: I & II Programs approved by the Accreditation Council for Pharmacy Education (ACPE), the American Medical Association (AMA) as Category 1 Continuing Medical Education (CME) and accredited by the Accreditation Council for Continuing Medical Education subject to the following conditions. (A). Pharmacists may receive credit for the completion of the same CME course only once during a license period. (B). Pharmacists who present approved CME programs may receive credit for the time expended during the actual presentation of the program. Pharmacists may receive credit for the same presentation only once during a license period. (C). Proof of completion of a CME course shall contain the following information: (i). name of the participant; (ii). title and completion date of the program; (iii). name of the approved provider sponsoring or cosponsoring the program; (iv). number of contact hours and/or CEUs awarded; and (v). a dated certifying signature of the approved provider.

Which of the following is/are the minimum requirement(s) to work as a certified pharmacy technician? I. Must have a high school diploma or a high school equivalency certificate or be working to achieve an equivalent diploma or certificate. II. Must have passed a board-approved pharmacy technician certification examination. III. Must have a degree from an approved college.

Answer: I & II The board shall require that a pharmacy technician: (1). Have a high school diploma or a high school equivalency certificate or be working to achieve an equivalent diploma or certificate; and (2). have passed a board-approved pharmacy technician certification examination.

The transfer of original prescription drug order information for Tylenol No.3 shall be communicated directly between: I. two pharmacists II. a pharmacist and a pharmacy-intern III. two pharmacy-interns

Answer: I & II Transfer of prescription drug order information. For the purpose of refill or initial dispensing, the transfer of original prescription drug order information is permissible between pharmacies, subject to the following requirements: (A). the transfer of original prescription drug order information for controlled substances listed in Schedule III, IV, or V is permissible between pharmacies on a one-time basis; (B). the transfer of original prescription drug order information for dangerous drugs is permissible between pharmacies without limitation up to the number of originally authorized refills; (C). The transfer is communicated orally by telephone or via facsimile directly by a pharmacist to another pharmacist; by a pharmacist to a student-intern, extended-intern, or resident-intern; or by a student-intern, extended-intern, or resident-intern to another pharmacist. (D). both the original and the transferred prescription drug order are maintained for a period of two years from the date of last refill; (E). the pharmacist or pharmacist intern transferring the prescription drug order information shall: (i). write the word "void" on the face of the invalidated prescription drug order; and (ii). record on the reverse of the invalidated prescription drug order the following information: (I). the name, address, and if a controlled substance, the DEA registration number of the pharmacy to which such prescription drug order is transferred; (II). the name of the pharmacist or pharmacist intern receiving the prescription drug order information; (III). the name of the pharmacist or pharmacist intern transferring the prescription drug order information; and (IV). the date of the transfer; (F). the pharmacist or pharmacist intern receiving the transferred prescription drug order information shall: (i). write the word "transfer" on the face of the transferred prescription drug order; and (ii). record on the transferred prescription drug order the following information: (I). original date of issuance and date of dispensing or receipt, if different from date of issuance; (II). original prescription number and the number of refills authorized on the original prescription drug order; (III). number of valid refills remaining and the date of last refill, if applicable; (IV). name, address, and if a controlled substance, the DEA registration number of the pharmacy from which such prescription information is transferred; and (V). name of the pharmacist or pharmacist intern transferring the prescription drug order information. (5). A pharmacist or pharmacist intern may not refuse to transfer original prescription information to another pharmacist or pharmacist intern who is acting on behalf of a patient and who is making a request for this information as specified in paragraph (4) of this subsection.

A patient wants to return Hydrocodone, Furosemide and a sealed pack of Ipratropium. Which one can be accepted by the pharmacist for the reselling purpose? I. Hydrocodone II. Furosemide III. Ipratropium

Answer: None According to Health and Safety Code, a pharmacist may not accept an unused prescription or drug, in whole or in part, for the purpose of resale or re-dispensing to any person from a PATIENT, after the prescription or drug has been originally dispensed or sold. Prescriptions that have not been picked up by or delivered to the patient or patient's agent may be returned to the pharmacy's stock for dispensing. The only exception for this law is the pharmacist who practices in or serves as a consultant for a health care facility. A pharmacist who works for a health care facility may return certain unused drugs, other than a controlled substance. The unused drugs must: (1). Be approved by the federal Food and Drug Administration and be: (A). sealed in the manufacturer's original unopened tamper-evident packaging and either individually packaged or packaged in unit-dose packaging; (B). oral or parenteral medication in sealed single-dose containers approved by the federal Food and Drug Administration; (C). topical or inhalant drugs in sealed units-of-use containers approved by the federal Food and Drug Administration; or (D). parenteral medications in sealed multiple-dose containers approved by the federal Food and Drug Administration from which doses have not been withdrawn. (E). have not been in the physical possession of the person for whom it was prescribed.

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: Prilosec capsules 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.

In an individually owned pharmacy, a pharmacist has a small fish pot in a pharmacy meal-break area. Which of the following is TRUE? a. Should not be kept within pharmacy area. b. Can be kept within pharmacy area once approved by local health jurisdictions. c. Can be kept within pharmacy area once approved by drug inspector of state. d. Can be kept within pharmacy area under Texas Administrative Code.

Answer: Should not be kept within pharmacy area Under Texas Administrative Code, animals, including birds and reptiles, shall not be kept within the pharmacy and in immediately adjacent areas under the control of the pharmacy. This provision does not apply to fish in aquariums, guide dogs accompanying disabled persons, or animals for sale to the general public in a separate area that is inspected by local health jurisdictions.

PL is visiting Texas from Maryland. On his stay in Texas, he suffers from severe tooth pain. Upon request, his physician in Maryland calls a pharmacist in Texas and asks him to dispense a 3-day supply of Tylenol No. 3. Under Texas Pharmacy Law, can the pharmacist fill this prescription? a. Yes b. No c. It's up to the pharmacist d. Cannot say

Answer: Yes Under Texas State Pharmacy Law, a pharmacist may dispense prescription drug orders for controlled substances in Schedule III, IV, or V issued by a physician, dentist, veterinarian, or podiatrist in another state provided: 1. the prescription drug order is a written, oral, or telephonically or electronically communicated prescription, as allowed by the DEA issued by a person practicing in another state and licensed by another state as a physician, dentist, veterinarian, or podiatrist, who has a current federal DEA registration number, and who may legally prescribe Schedule III, IV, or V controlled substances in such other state; 2. the prescription drug order is not dispensed or refilled more than six months from the initial date of issuance and may not be refilled more than five times; and 3. if there are no refill instructions on the original prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original prescription drug order have been dispensed, a new prescription drug order is obtained from the prescribing practitioner prior to dispensing any additional quantities of controlled substances. In addition, a pharmacist may not dispense a verbal prescription drug order for a dangerous drug or a controlled substance issued by a practitioner licensed in the Dominion of Canada or the United Mexican States unless the practitioner is also licensed in Texas.

MJ has brought a prescription for Amoxicillin 500 mg 1 po tid to a pharmacy. The pharmacy only has an Amoxicillin Suspension 250 mg/5 cc in a stock. The pharmacist has tried to contact the prescriber, but he has been out of town for the weekend. Under these circumstances, the pharmacist may:

Answer: dispense a suspension but shall notify the prescriber as soon as possible. A pharmacist may dispense a dosage form of a drug product different from that prescribed, such as a tablet instead of a capsule or liquid instead of tablets, provided: (i). the patient consents to the dosage form substitution; (ii). the pharmacist notifies the practitioner of the dosage form substitution; and (iii). the dosage form so dispensed: (I). contains the identical amount of the active ingredients as the dosage prescribed for the patient; (II). is not an enteric-coated or time release product; (III). does not alter desired clinical outcomes.

Centralized prescription drug or medication order processing includes all of the following EXCEPT: a. data entering and transferring of prescription drug order information. b. performing therapeutic interventions. c. obtaining refill and substitution authorizations. d. dispensing of a prescription drug order.

Answer: dispensing of a prescription drug order Centralized prescription drug or medication order processing--the processing of a prescription drug or medication orders by a Class A, Class C, or Class E pharmacy on behalf of another pharmacy, a health care provider, or a payor. Centralized prescription drug or medication order processing DOES NOT include the dispensing of a prescription drug order but includes any of the following: (1). receiving, interpreting, or clarifying prescription drug or medication drug orders; (2). data entering and transferring of prescription drug or medication order information; (3). performing drug regimen review; (4). obtaining refill and substitution authorizations; (5). interpreting clinical data for prior authorization for dispensing; (6). performing therapeutic interventions; and (7). providing drug information concerning a patient's prescription.

A preceptor may supervise only: a. one pharmacist-intern at any given time. b. two pharmacist-interns at any given time. c. three pharmacist-interns at any given time. d. four pharmacist-interns at any given time.

Answer: one pharmacist-intern at any given time (a). Preceptor requirements. (1). Preceptors shall be: (A). a pharmacist whose license to practice pharmacy in Texas is current and not on inactive status with the board; or (B). a healthcare professional preceptor. (2). A pharmacist preceptor shall publicly display the pharmacist preceptor certificate with his/her license to practice pharmacy and the license renewal certificate. (3). To be recognized as a pharmacist preceptor, a pharmacist must: (A). have at least: (i). one year of experience as a licensed pharmacist; or (ii). six months of residency training if the pharmacy resident is in a program accredited by the American Society of Health-System Pharmacists; (B). have completed: (i). for initial certification, three hours of pharmacist preceptor training provided by an ACPE approved provider within the previous two years. Such training shall be: (I). developed by a Texas college/school of pharmacy; or (II). approved by: (-a-). a committee comprised of the Texas college/schools of pharmacy; or (-b-). the board. A preceptor may supervise only one pharmacist-intern at any given time (1:1 ratio) except as provided in paragraph (2) of this subsection. (2). The following is applicable to Texas college/school of pharmacy internship program only. (A). Supervision. Supervision of a pharmacist-intern shall be: (i). direct supervision when the student-intern or intern-trainee is engaged in functions associated with the preparation and delivery of prescription or medication drug orders; and (ii). general supervision when the student-intern or intern-trainee is engaged in functions not associated with the preparation and delivery of prescription or medication drug orders. (B). Exceptions to the 1:1 ratio. There is no ratio requirement for preceptors supervising intern-trainees and student-interns as a part of a Texas college/school of pharmacy program.

A prescription for Adderall XR written and signed by a physician assistant: a. should be filled by the pharmacist. b. should be filled by the pharmacist after verbally confirming with the prescriber. c. should only be filled by the pharmacist if the physician assistant is working for a hospital. d. should only be filled if the prescriber sends a written authorization form which clearly indicates that a physician assistant is authorized to carry out or sign a prescription drug order.

Answer: should only be filled by the pharmacist if the physician assistant is working for a hospital A physician may delegate the prescribing or ordering of a controlled substance listed in Schedule II to the physician assistant or advanced practice registered nurse (**)established by the commissioner of the Department of State Health Services under Chapter 481, Health and Safety Code, only: (1). In a hospital facility-based practice under Section 157.054, in accordance with policies approved by the hospital 's medical staff or a committee of the hospital 's medical staff as provided by the hospital bylaws to ensure patient safety, and as part of the care provided to a patient who: (A). has been admitted to the hospital for an intended length of stay of 24 hours or greater; or (B). is receiving services in the emergency department of the hospital; or (2). As part of the plan of care for the treatment of a person who has executed a written certification of a terminal illness, has elected to receive hospice care, and is receiving hospice treatment from a qualified hospice provider. (**) Please note: Schedule III, IV or V (up to 90-day supply) are allowed by the physician assistant or advanced practice registered nurse without any restrictions.

A pharmacist 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 verbal new order from a prescriber.

Answer: taking a verbal new order from a prescriber Pharmacy technicians and pharmacy technician trainees may perform only nonjudgmental technical duties associated with the preparation and distribution of prescription drugs, as follows: (i). initiating and receiving refill authorization requests; (ii). entering prescription data into a data processing system; (iii). taking a stock bottle from the shelf for a prescription; (iv). preparing and packaging prescription drug orders (i.e., counting tablets/capsules, measuring liquids and placing them in the prescription container); (v). affixing prescription labels and auxiliary labels to the prescription container; (vi). reconstituting medications; (vii). prepackaging and labeling prepackaged drugs; (viii). loading bulk unlabeled drugs into an automated dispensing system provided a pharmacist verifies that the system is properly loaded prior to use; (ix). compounding non-sterile and sterile prescription drug orders; and (x). compounding bulk preparations.

A wholesaler who sells, transfers, or otherwise furnishes a product containing ephedrine, pseudoephedrine, or norpseudoephedrine to a retailer shall make an accurate and legible record of the transaction and maintain the record for at least:

Answer: two years after the date of the transaction. A wholesaler who sells, transfers, or otherwise furnishes a product containing ephedrine, pseudoephedrine, or norpseudoephedrine to a retailer shall make an accurate and legible record of the transaction and maintain the record for at least two years after the date of the transaction, [Texas Controlled Substances Act Title 6, Subtitle C, Chapter 481, Subchapter A, 481.0771(a),(2)].

must be done by the pharmacy permit holder before closing or ceasing pharmacy's operation at a specific place

At least 14 days prior to the closing of a pharmacy the pharmacist-in-charge shall comply with the following. (1). If the pharmacy is registered to possess controlled substances, send a written notification to the appropriate divisional office of the Drug Enforcement Administration (DEA) containing the following information: (A). the name, address, and DEA registration number of the pharmacy; (B). the anticipated date of closing; (C). the name, address, and DEA registration number of the pharmacy acquiring the controlled substances; and (D). the date on which the transfer of controlled substances will occur. (2). If the pharmacy dispenses prescription drug orders, post a closing notice sign in a conspicuous place in the front of the prescription department and at all public entrance doors to the pharmacy. Such closing notice sign shall contain the following information: (A). the date of closing; and (B). the name, address, and telephone number of the pharmacy acquiring the prescription drug orders, including refill information and patient medication records of the pharmacy. (b). On the date of closing, the pharmacist-in-charge shall comply with the following: (1). take an inventory as specified in §291.17 of this title (relating to Inventory Requirements); (2). remove all prescription drugs from the pharmacy by one or a combination of the following methods: (A). return prescription drugs to manufacturer or supplier (for credit/disposal); (B). transfer (sell or give away) prescription drugs to a person who is legally entitled to possess drugs, such as a hospital, or another pharmacy; and (C). destroy the prescription drugs following procedures specified in §303.2 of this title (relating to Disposal of Stock Prescription Drugs); (3). if the pharmacy dispenses prescription drug orders: (A). transfer the prescription drug order files, including refill information, and patient medication records to a licensed pharmacy within a reasonable distance of the closing pharmacy; and (B). move all signs or notify the landlord or owner of the property that it is unlawful to use the word "pharmacy" either in English or any other language, or any other word or combination of words of the same or similar meaning, or any graphic representation that would mislead or tend to mislead the public that a pharmacy is located at the address.

List of Schedule V controlled drugs

Codeine preparations - 200 mg per 100 ml or 100 gm (Robitussin AC, Phenergan with Codeine) Difenoxin preparations - 0.5 mg Difenoxin + 25mcg Atropine sulfate (Motofen) Dihydrocodeine preparations 100 mg per 100 ml or 100 gm Diphenoxylate preparations- 2.5 mg Diphenoxylate + 25mcg Atropine sulfate (Lomotil, Logen) Ethylmorphine preparations 100 mg per 100 ml or 100 gm Opium preparations - 100 mg per 100 ml or gm (Parepectolin, Kapectolin PG, Kaolin Pectin P.G.) Lyrica - Pregabalin Vimpat - Lacosamide Potiga - Ezogabine

List of Schedule I controlled drugs

Difenoxin (Lyspafen) Dihydromorphine Heroin (Diacetylmorphine, diamorphine) Lysergic acid diethylamide (LSD, lysergide) Marijuana (Cannabis, marijuana) Mescaline Peyote

True/False The ratio of on-site pharmacists to pharmacy technicians and pharmacy technician trainees may be 1:3, provided the pharmacist is on-site and at least one of the three is a pharmacy technician.

False (A). Except as provided in subparagraph (B) of this paragraph, the ratio of on-site pharmacists to pharmacy technicians and pharmacy technician trainees may be 1:4 (Not 1:3), provided the pharmacist is on-site and at least one of the four is a pharmacy technician. The ratio of pharmacists to pharmacy technician trainees may not exceed 1:3. (B). A Class A pharmacy may have a ratio of on-site pharmacists to pharmacy technicians/pharmacy technician trainees of 1:5 provided: (i). the Class A pharmacy: (I). dispenses no more than 20 different prescription drugs; and (II). does not produce sterile preparations including intravenous or intramuscular drugs on-site; and (ii). the following conditions are met: (I). at least four are pharmacy technicians and not pharmacy technician trainees; and (II). The pharmacy has written policies and procedures regarding the supervision of pharmacy technicians and pharmacy technician trainees, including requirements that the pharmacy technicians and pharmacy technician trainees included in a 1:5 ratio may be involved only in one process at a time. For example, a technician/trainee who is compounding non-sterile preparations or who is involved in the preparation of prescription drug orders may not also call physicians for authorization of refills. --------------------------------------------------------- "At their February 2014, the Board voted to amend the ratio requirements for Class A, Class B, and Class G pharmacies. The ratio for pharmacists to pharmacy technicians in Class A and Class B pharmacies was increased to 1:4 and the ratio in Class G pharmacies was increased to 1:8."

True/False The prescription drug order signed by a practitioner's agent must include the name and DEA number of the supervising practitioner.

False (A). Practitioner's signature. (i). Written prescription drug orders shall be: (I). manually signed by the practitioner; or (II). electronically signed by the practitioner using a system which electronically replicates the practitioner's manual signature on the written prescription, provided: (-a-). that security features of the system require the practitioner to authorize each use; and (-b-). the prescription is printed on paper that is designed to prevent unauthorized copying of a completed prescription and to prevent the erasure or modification of information written on the prescription by the prescribing practitioner. (For example, the paper contains security provisions against copying that results in some indication on the copy that it is a copy and therefore render the prescription null and void.) (ii). Prescription drug orders for Schedule II controlled substances shall be issued on an official prescription form as required by the Texas Controlled Substances Act, §481.075, and be manually signed by the practitioner. (iii). A practitioner may sign a prescription drug order in the same manner as he would sign a check or legal document, e.g. J.H. Smith or John H. Smith. (iv). Rubber stamped or otherwise reproduced signatures may not be used. (v). The prescription drug order may NOT be signed by a practitioner's agent but may be prepared by an agent for the signature of a practitioner. However, the prescribing practitioner is responsible in case the prescription drug order does not conform in all essential respects to the law and regulations.

True/False According to Texas State Pharmacy Law, it is legal for a physician assistant to call in for a prescription of Biaxin if he/she receives a verbal authorization from a prescribing practitioner to do so.

False According to Texas State Pharmacy Law, an agent (a Physician assistant) of a practitioner commits an offense if the agent communicates by telephone a prescription unless the agent is designated in writing (a verbal authorization is not enough) under Section 483.022 as authorized by the practitioner to communicate prescriptions by telephone.

True/False A pharmacist who administers epinephrine through an auto-injector to a patient shall report the use to the patient's primary care physician, as identified by the patient, as soon as practical, but in no event more than 24 hours from the time of administering the epinephrine.

False (c). Administration requirements. (1). Pharmacists may administer epinephrine through an auto-injector to a patient in an emergency situation. (2). The authority of a pharmacist to administer epinephrine through an auto-injector may not be delegated. (e). Notifications. (1). A pharmacist who administers epinephrine through an auto-injector to a patient shall report the use to the patient's primary care physician, as identified by the patient, as soon as practical, but in no event more than 72 hours (not 24 hours) from the time of administering the epinephrine. (2). Immediately, after administering the epinephrine auto-injector, the pharmacist shall ensure that 911 is called and the patient is evaluated by emergency personnel for possible transfer to the nearest emergency department for additional evaluation, monitoring, and treatment. (3). The notifications required in paragraph (1) of this subsection shall include the: (A). name of the patient; (B). age of the patient if under 8 years of age; (C). name and manufacturer of the epinephrine auto-injector; (D). date the epinephrine was administered; (E). name and title of the person administering the epinephrine; and (F). name, address, and telephone number of the pharmacy. The notification required to be made under this section shall be kept by the pharmacy and such records shall be available for at least two years from the date of such record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement or regulatory agencies.

True/False A business establishment shall maintain each record of OTC sale of a product containing pseudoephedrine, ephedrine or norephedrine for at least five years from the date it is sold.

False A business establishment shall maintain each record of OTC sale of a product containing pseudoephedrine, ephedrine or norephedrine until at least the second anniversary of the date the record is made and shall make each record available on request by the department or any local, state, or federal law enforcement agency, including the United States Drug Enforcement Administration. This subsection does not apply to a business establishment that has used a real-time electronic logging system for longer than two years. A business establishment that has used a real-time electronic logging system for longer than two years shall destroy all paper records maintained under this section unless the destruction is otherwise prohibited by law.

True/False A pharmacist in a pharmacy may accept and destroy controlled drugs that have been previously dispensed to a patient and returned to a pharmacy by the patient or an agent of the patient.

False A pharmacist in a pharmacy may accept and destroy dangerous drugs (NOT controlled substances) that have been previously dispensed to a patient and returned to a pharmacy by the patient or an agent of the patient. However, a pharmacist may not accept controlled substances that have been previously dispensed to a patient unless allowed by federal laws of the Drug Enforcement Administration. The following procedures shall be followed in destroying dangerous drugs. (1). The dangerous drugs shall be destroyed in a manner to render the drugs unfit for human consumption and disposed of in compliance with all applicable state and federal requirements. (2). Documentation shall be maintained that includes the following information: (A). name and address of the dispensing pharmacy; (B). unique identification number assigned to the prescription, if available; (C). name and strength of the dangerous drug; and (D). signature of the pharmacist. All inventory records and forms of disposed drugs shall be maintained for two years from the date of transfer, disposal, or destruction and be available for inspection by an agent of the board, Texas Department of Public Safety, Drug Enforcement Administration, or any other agent authorized to inspect such records.

True/False A pharmacist may dispense a prescription drug order for a Schedule II, III, IV, or V controlled substance issued by a practitioner in the Dominion of Canada or the United Mexican States.

False A pharmacist may not dispense a prescription drug order for a Schedule II, III, IV, or V controlled substance issued by a practitioner in the Dominion of Canada or the United Mexican States. A pharmacist may not dispense a verbal prescription drug order for a dangerous drug or a controlled substance issued by a practitioner licensed in the Dominion of Canada or the United Mexican States unless the practitioner is also licensed in Texas. A pharmacist may not dispense an electronic prescription drug order for a dangerous drug or controlled substance issued by a practitioner licensed in the Dominion of Canada or the United Mexican States unless the practitioner is also licensed in Texas. A pharmacist may dispense a dangerous drug prescription issued by a person licensed in the Dominion of Canada or the United Mexican States as a physician, dentist, veterinarian, or podiatrist provided: (I). the prescription drug order is an original written prescription; and (II). if there are no refill instructions on the original written prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original written prescription drug order have been dispensed, a new written prescription drug order shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of dangerous drugs.

True/False A pharmacy may use an automated storage and distribution device to deliver a previously verified NEW prescription to a patient or patient's agent when the pharmacy is closed.

False A pharmacy may use an automated storage and distribution device to deliver a previously verified prescription to a patient or patient's agent when the pharmacy is open or closed provided: (A). the device is used to deliver REFILLS of prescription drug orders and shall NOT BE used to deliver NEW prescriptions; (B). the automated storage and distribution device may not be used to deliver a controlled substance; (C). drugs stored in the automated storage and distribution device are stored at proper temperatures; (D). the patient or patient's agent is given the option to use the system; (E). the patient or patient's agent has access to a pharmacist for questions regarding the prescription at the pharmacy where the automated storage and distribution device is located, by a telephone available at the pharmacy that connects directly to another pharmacy, or by a telephone available at the pharmacy and a posted telephone number to reach another pharmacy; (F). the pharmacist-in-charge is responsible for the supervision of the operation of the system; (G). the automated storage and distribution device has been tested by the pharmacy and found to dispense prescriptions accurately. The pharmacy shall make the results of such testing available to the board upon request; (H). the automated storage and distribution device may be loaded with previously verified prescriptions only by a pharmacist or by pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist; (I). the pharmacy will make the automated storage and distribution device available for inspection by the board; (J). the automated storage and distribution device is located within the pharmacy building whereby pharmacy staff has access to the device from within the prescription department and patients have access to the device from outside the prescription department. The device may not be located on an outside wall of the pharmacy and may not be accessible from a drive-thru; (K). the automated storage and distribution device is secure from access and removal of prescription drug orders by unauthorized individuals; (L). the automated storage and distribution device has adequate security system to prevent unauthorized access and to maintain patient confidentiality; and (M). the automated storage and distribution device records a digital image of the individual accessing the device to pick-up a prescription and such record is maintained by the pharmacy for two years.

True/False A prescribing practitioner may use an official prescription form only to prescribe a schedule II controlled substance.

False A prescribing practitioner may use an official prescription form only to prescribe a controlled substance (not limited to C-II).

True/False According to Texas State Pharmacy Law, prescription drug orders for dangerous drugs or nonprescription drugs may not be refilled after 15-month from the date of issuance of the original prescription drug order.

False According to Texas State Pharmacy Law, prescription drug orders for dangerous drugs or nonprescription drugs may not be refilled after one year from the date of issuance of the original prescription drug order. If one year has expired from the date of issuance of an original prescription drug order for a dangerous drug or nonprescription drug, authorization shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of the drug.

True/False A provider pharmacy shall notify the board in writing within 30 days of a change of location, discontinuance of service, or closure of a remote site where an automated pharmacy system is operated by the pharmacy.

False Automated pharmacy system--A mechanical system that dispenses prescription drugs and maintains related transaction information. Remote site--A facility not located at the same location as a Class A or Class C pharmacy, at which remote pharmacy services are provided using an automated pharmacy dispensing system. Provider pharmacy--The community pharmacy (Class A) or the institutional pharmacy (Class C) providing remote pharmacy services. A provider pharmacy shall notify the board in writing within 10 days (NOT 30 Days) of a change of location, discontinuance of service, or closure of: (I). a remote site where an automated pharmacy system is operated by the pharmacy; or (II). a remote pharmacy service at a remote site.

True/False If a licensee or registrant obtains controlled substances or dangerous drugs from a pharmacy by means of a forged prescription, the pharmacy shall report in writing to the board within 7 days on discovery of such forgery.

False If a licensee or registrant obtains controlled substances or dangerous drugs from a pharmacy by means of a forged prescription, the pharmacy shall report in writing to the board IMMEDIATELY on discovery of such forgery. A pharmacy shall be in compliance with this subsection by submitting to the board the following: (1). name of licensee or registrant obtaining controlled substances or dangerous drugs by forged prescription; (2). date(s) of forged prescription(s); (3). name(s) and amount(s) of drug(s); and (4). copies of forged prescriptions.

True/False Not later than 3 business days after receipt of an order for a product containing ephedrine, pseudoephedrine, or norpseudoephedrine that requests delivery of a suspicious quantity of the product as determined by department rule, a wholesaler shall submit to the director a report of the order in accordance with department rule.

False Not later than 10 business days after receipt of an order for a product containing ephedrine, pseudoephedrine, or norpseudoephedrine that requests delivery of a suspicious quantity of the product as determined by department rule, a wholesaler shall submit to the director a report of the order in accordance with department rule.

True/False The requirement to maintain original prescription records in three separate files is waived if original prescription records are stored using microfilm, microfiche, or other system which is capable of producing a direct image of the original prescription records.

False Original prescription records other than prescriptions for Schedule II controlled substances may be stored on microfilm, microfiche, or other system which is capable of producing a direct image of the original prescription record, e.g., digitalized imaging system. If original prescription records are stored in a direct imaging system, the following is applicable: (i). the record of refills recorded on the original prescription must also be stored in this system; (ii). the original prescription records must be maintained in numerical order and separated in three files as specified in 291.34(b)(5)(D); and (iii). the pharmacy must provide immediate access to equipment necessary to render the records easily readable.

True/False The daily hard-copy printout shall be produced within 48 hours of the date on which the prescription drug orders were dispensed and shall be maintained in a separate file at the pharmacy.

False The daily hard-copy printout shall be produced within 72 hours (not 48 hours) of the date on which the prescription drug orders were dispensed and shall be maintained in a separate file at the pharmacy. Records of controlled substances shall be readily retrievable from records of noncontrolled substances. Each individual pharmacist who dispenses or refills a prescription drug order shall verify that the data indicated on the daily hard-copy printout is correct, by dating and signing such document in the same manner as signing a check or legal document (e.g., J.H. Smith, or John H. Smith) within seven days from the date of dispensing. The pharmacy shall maintain a log book in which each individual pharmacist using the data processing system shall sign a statement each day, attesting to the fact that the information entered into the data processing system that day has been reviewed by him or her and is correct as entered. Such log book shall be maintained at the pharmacy employing such a system for a period of two years after the date of dispensing; provided, however, that the data processing system can produce the hard-copy printout on demand by an authorized agent of the Texas State Board of Pharmacy. If no printer is available on site, the hard-copy printout shall be available within 72 hours with a certification by the individual providing the printout, which states that the printout is true and correct as of the date of entry and such information has not been altered, amended, or modified.

True/False The pharmacy must respond to a request for non-emergency confidential records (requested by a patient or a patient's agent or any authorized third party) within 72 hours after receipt of the request.

False The pharmacy may require a patient or a patient's agent or any authorized third party to make requests for confidential records in writing, provided such a requirement has been communicated to the requestor. The pharmacy must respond to a request for confidential records no later than thirty days after receipt of the request by providing a copy of the records or, with the consent of the requestor, a summary or explanation of such information. If the pharmacy is unable to take such action within thirty days of receiving the request, the pharmacy may extend the time for such action by no more than thirty days, provided that: (A). the pharmacy provides the requestor with a written statement of the reasons for the delay and the date by which the pharmacy will respond to the request; and (B). the pharmacy shall have only one such extension of time. (2). The pharmacy must provide confidential records as requested by either: (A). mailing a copy of the records; or (B). with the consent of the requestor arranging for a convenient time and place for the individual to inspect or obtain a copy of the records. (3). Access to confidential records may be expedited at the request of a patient or a patient's agent if there is a medical emergency. The pharmacy must respond to a request for expedited access to confidential records within 24 hours if the records are maintained at the pharmacy or within 72 hours if the records are stored off-site.

True/False In Texas, the signature of the pharmacist-in-charge and the date of the inventory shall be notarized within seven working days of the completed annual inventory.

False The signature of the pharmacist-in-charge and the date of the inventory shall be notarized within three days after the day the inventory is completed, excluding Saturdays, Sundays, and federal holidays.

Why is Fiorinal a Schedule III drug?

Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine. Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine. The only difference between these two is the aspirin in Fiorinal vs acetaminophen in Fioricet. Interesting to note that Fiorinal is a scheduled class III substance, while Fioricet has a non-scheduled status. It seems really strange because both combinations contain equal amount of the controlled substance butalbital. The exemption requires that one of the active ingredients be a non-narcotic controlled substance and one of the others be a non-scheduled compound. The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophenn) is added. The ratio required for exemption is 70 mg of acetaminophen to 15 mg of butalbital. In contrast, the ratio of aspirin to butalbital is 188 mg to 15 mg. The acetaminophen to butalbital ratio is approximately 97 mg to 15 mg in Fioricet, thus it is exempt from scheduling. In Fiorinal the aspirin to butalbital ratio is approximately 97 mg to 15 mg, which is less than the 188mg:15mg ratio, so it is classified as a Schedule III substance.

labeling the dispensing container for Lipitor 10mg or its generic equivalent

I. Lipitor 10 mg II. Atorvastatin (Sandoz) 10 mg - Substituted for Lipitor III. Atorvastatin (Mylan) 10 mg - Substituted for Lipitor No drug product may be dispensed unless the prescription label discloses the brand name and strength, or the generic name, strength, and manufacturer or distributor of the drug product dispensed unless the prescribing practitioner requests omission of the above information. If the pharmacist has selected a generically equivalent drug pursuant to the provisions of the Act, Chapter 562, the statement "Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where "Brand Name" is the actual name of the brand name product prescribed; The name shall be either: (-a-). the brand name; or (-b-). if no brand name, then the generic name and name of the manufacturer or distributor of such generic drug. The name of the manufacturer or distributor may be reduced to an abbreviation or initials, provided the abbreviation or initials are sufficient to identify the manufacturer or distributor. For combination drug products or non-sterile compounded drug products having no brand name, the principal active ingredients shall be indicated on the label.

In the case of Government declared the state of disaster, the dispensed quantity of the refilled drug without the authorization of the prescribing practitioner should be limited to a:

If a natural or manmade disaster has occurred that prohibits the pharmacist from being able to contact the practitioner, a pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided: (i). failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering; (ii). the quantity of prescription drug dispensed does not exceed a 30-day supply; (iii). the governor has declared a state of disaster; (iv). the board, through the executive director, has notified pharmacies that pharmacists may dispense up to a 30-day supply of prescription drugs; (v). the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills; (vi). the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time; (ix). if the prescription was initially filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided: (I). the patient has the prescription container, label, receipt or other documentation from the other pharmacy which contains the essential information; (II). after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription; (III). the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of clause (i) of this subparagraph.

Requirements for an animal prescription

If the prescription is for an animal, the prescription shall state the species of animal for which the drug is prescribed and the full name and address of the owner of the animal.

An emergency oral prescription for Schedule II controlled drugs must be mailed to dispensing pharmacy by an authorized prescriber within:

In an emergency, a person may dispense or administer a controlled substance listed in Schedule II on the oral or telephonically communicated prescription of a practitioner. The person who administers or dispenses the substance shall: A pharmacist, promptly write the oral or telephonically communicated prescription and include in the written record of the prescription the name, address, and Federal Drug Enforcement Administration number issued for prescribing a controlled substance of the prescribing practitioner. Not later than the seventh day after the date a prescribing practitioner authorizes an emergency oral or telephonically communicated prescription, the prescribing practitioner shall cause a written or electronic prescription to be delivered to the dispensing pharmacist at the pharmacy where the prescription was dispensed. A written prescription may be delivered in person or by mail. The envelope of a prescription delivered by mail must be postmarked not later than the seventh day after the date the prescription was authorized. On receipt of a written prescription, the dispensing pharmacy shall file the transcription of the telephonically communicated prescription and the pharmacy copy and shall send information to the board as required by Section 481.075. On receipt of an electronic prescription, the pharmacist shall annotate the electronic prescription record with the original authorization and date of the emergency oral or telephonically communicated prescription.

In Texas, pharmacy license expire on which of the following dates each year?

May 31 The board may adopt a system under which pharmacy licenses expire on various dates during the year or every other year, as appropriate. If the board changes the expiration date of a license, the board shall prorate the license renewal fee to cover the number of months for which the license is valid for the year in which the date is changed. The total license renewal fee is due on the new expiration date. A pharmacy license must be renewed annually or biennially as determined by the board.

According to Texas State Pharmacy Law, the prescription record should be kept on file for:

Original prescriptions shall be maintained by the pharmacy in numerical order and remain legible for a period of two years from the date of filling or the date of the last refill dispensed, [Texas Administrative Code Title 22, Part 15, Chapter 291, Subchapter B, 291.34(b)(6)(B)].

correct filing method for controlled substances

Original prescriptions shall be maintained in three separate files as follows: (i). prescriptions for controlled substances listed in Schedule II; (ii). prescriptions for controlled substances listed in Schedules III-V; and (iii). prescriptions for dangerous drugs and nonprescription drugs. Original prescription records other than prescriptions for Schedule II controlled substances may be stored on microfilm, microfiche, or other system which is capable of producing a direct image of the original prescription record, e.g., digitalized imaging system. If original prescription records are stored in a direct imaging system, the following is applicable: (i). the record of refills recorded on the original prescription must also be stored in this system; (ii). the original prescription records must be maintained in numerical order and separated in three files and (iii). the pharmacy must provide immediate access to equipment necessary to render the records easily readable. Rule: 291.34(a)(2)(3): Each registered pharmacy shall maintain the inventories and records of controlled substances (OTHER THAN PRESCRIPTION ORDER) as follows: 1). Records of controlled substances listed in Schedule II shall be maintained separately from all other records of the pharmacy. 2). Records of controlled substances, other than prescription drug orders, listed in Schedules III-V shall be maintained separately or readily retrievable from all other records of the pharmacy. For purposes of this subsection, readily retrievable means that the controlled substances shall be asterisked, red-lined, or in some other manner readily identifiable apart from all other items appearing on the record.

A patient comes to a pharmacy with a prescription for Oxycontin. After processing the claim, the pharmacist finds out that he does not have enough quantity to dispense the full supply. Under this circumstance, the pharmacist may:

Reverse the claim and return the prescription back to the patient. Oxycontin is a schedule II controlled substance. When dealing with schedule II controlled substances, it is better to reverse the claim and return the prescription to the patient. The other option would be to supply partial quantities of the written prescription. 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 so notify the prescribing individual practitioner. 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: (1). date of the partial filling; (2). quantity dispensed; (3). remaining quantity authorized to be dispensed; and (4). identification of the dispensing pharmacist.

the following requires a DEA 222 form for purchase

Schedule I and II controlled substances require a DEA 222 order form for purchase Each form contains three copies (i.e. Copy 1, Copy 2 and Copy 3). The purchaser completes the form and submits the Copy 1 and Copy 2 of the form to the supplier, and retains Copy 3 for his/her own record. The partially filled order must be filled within 60 days from the date of issuance. The order form is no longer valid after 60 days from the time it was executed by purchaser.

Phenergan with Codeine syrup is classified as:

Schedule V

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:

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). 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.

The actual destruction of the controlled substances can be witnessed by:

The consultant pharmacist, if in good standing with the Texas State Board of Pharmacy, is authorized to destroy dangerous drugs and controlled substances dispensed to patients in health care facilities or institutions, providing the following conditions are met. (A). A written agreement exists between the facility and the consultant pharmacist. (B). The drugs are inventoried and such inventory is verified by the consultant pharmacist. The actual destruction of the drugs is witnessed by one of the following: (i). a commissioned peace officer; (ii). an agent of the Texas State Board of Pharmacy; (iii). an agent of the Texas Health and Human Services Commission, authorized by the Texas State Board of Pharmacy to destroy drugs; (iv). an agent of the Texas Department of State Health Services, authorized by the Texas State Board of Pharmacy to destroy drugs; or (v). any two individuals working in the following capacities at the facility: (I). facility administrator; (II). director of nursing; (III). acting director of nursing; or (IV). licensed nurse.

List of Schedule IV controlled drugs

Tramadol (Ultram) Carisoprodol (Soma) Alprazolam (Xanax) Barbital(Barbitone) Butorphanol (Stadol, Stadol NS, Torbugesic, Torbutrol) Chloral hydrate (Noctec) Chlordiazepoxide (Librium, Libritabs, Limbitrol, SK-Lygen) Clonazepam (Klonopin, Clonopin) Clorazepate (Tranxene) Dexfenfluramine (Redux) Propoxyphene dosage forms with other ingredients (Darvon, Darvocet, Dolene, Propacet) Diazepam (Valium, Valrelease) Dichloralphenazone (Midrin) Difenoxin 1 mg/ Atropine 25 mcg (Motofen) Estazolam (ProSom, Domnamid, Eurodin, Nuctalon) Ethchlorvynol (Placidyl) Fenfluramine (Pondimin, Ponderal) Flurazepam (Dalmane) Lorazepam (Ativan) Mazindol (Sanorex, Mazanor) Meprobamate (Miltown, Equanil, Deprol, Equagesic, Meprospan) Midazolam (Versed) Modafinil (Provigil) Oxazepam (Serax, Serenid-D) Pemoline (Cylert) Pentazocine (Talwin, Talwin NX, Talacen, Talwin Compound) Phenobarbital (Luminal, Donnatal, Bellergal-S) Phentermine (Ionamin, Fastin, Adipex-P, Obe-Nix, Zantryl) Prazepam (Centrax) Quazepam (Doral, Dormalin) Sibutramine (Meridia) Temazepam (Restoril) Triazolam (Halcion) Zaleplon (Sonata) Zolpidem (Ambien) Eszopiclone (Lunesta)

True/False Not later than close of business on the day of discovery, a practitioner must report a lost or stolen official prescription form to the local police department or sheriff's office in an effective manner.

True (a) Report lost forms: Not later than close of business on the day of discovery, a practitioner must report a lost or stolen official prescription form to: (1) the local police department or sheriff's office in an effective manner; and (2) the board. (b) Recovery report: Not later than close of business on the day of recovery of an official prescription form previously reported lost or stolen, a practitioner must, before using the recovered form, notify: (1) the local law enforcement agency to which the matter was originally reported; and (2) the board. (c) Replacement/lost form. Not later than the close of business on the day that an official prescription is replaced or reported lost, with or without a replacement, the prescribing practitioner, or designated agent, shall report to the board the following: (1) patient name, address, date of birth or age; (2) all drug information; and (3) official prescription form control number.

True/False In Texas, an unused official prescription form is invalid and the practitioner must return the unused form to the director of Texas Prescription Program with an appropriate explanation not later than the 30th day after the date the practitioner's license to practice is suspended.

True (a). An unused official prescription form is invalid and the practitioner or another person acting on behalf of the practitioner must return the unused form to the department with an appropriate explanation not later than the 30th day after the date: (1). the practitioner's license to practice, Texas controlled substances registration number, or DEA number is canceled, revoked, suspended, denied, or surrendered or amended to exclude the handling of all Schedule II controlled substances; or (2). the practitioner is deceased. (b). An individual who is an institutional practitioner must return an unused official prescription form to the administrator of the hospital or other training institution upon completion or termination of the individual's training at the hospital or institution. The administrator must return an unused official prescription form to the department not later than the 30th day after the date the individual completes or terminates all training programs. (c). No individual may continue to use an official prescription form issued under an institutional practitioner's permit number or similar number after the individual has been properly and individually licensed as a practitioner by the appropriate state health regulatory agency.

True/False A practitioner registered with a narcotic treatment program pursuant to the Narcotic Addict Treatment Act of 1974 may administer, dispense and prescribe scheduled narcotic drugs that are approved by the FDA for the treatment of narcotic addiction.

True 1. Practitioners wishing to administer and dispense approved Schedule II controlled substances (that is, Methadone) for maintenance and detoxification treatment must obtain a separate DEA registration as a Narcotic Treatment Program. Application for registration as a Narcotic Treatment Program is made using DEA Form 363. 2. In addition to obtaining this separate DEA registration, this type of activity also requires the approval and registration of the Center for Substance Abuse Treatment (CSAT) within the Substance Abuse and Mental Health Services Administration (SAMHSA) of the Department of Health and Human Services (HHS), as well as the applicable state methadone authority. 3. If a practitioner wishes to prescribe, administer, or dispense Schedule III, IV, or V controlled substances approved for addiction treatment (i.e., buprenorphine drug products), the practitioner must request a waiver (Form SMA-167) and fulfill the requirements of CSAT. CSAT will then notify DEA of all waiver requests. DEA will review each request. If DEA approves this waiver, the practitioner will receive a Unique Identification Number. 4. If a practitioner chooses to dispense controlled substances, the practitioner must maintain, separate from all other records, for a period of at least two years, all required records of receipt, storage, and distribution. If a practitioner chooses to prescribe these controlled substances, the practitioner must utilize their Unique Identification Number on the prescription in addition to his/her regular DEA registration number. 5. An exception to the registration requirement, known as the "three day rule" (21CFR1306.07(b)), allows a practitioner who is not separately registered as a narcotic treatment program, to administer (but not prescribe) narcotic drugs to a patient for the purpose of relieving acute withdrawal symptoms while arranging for the patient's referral for treatment, under the following conditions: I. Not more than one day's medication may be administered or given to a patient at one time; II. This treatment may not be carried out for more than 72 hours and; III. This 72-hour period cannot be renewed or extended. 6. The 72-hour exception offers an opioid dependent individual relief from experiencing acute withdrawal symptoms, while the physician arranges placement in a maintenance/detoxification treatment program. This provision was established to augment, not to circumvent, the separate registration requirement. It should be noted that although Buprenex, a Schedule III controlled substance, is currently approved for the treatment of pain, it may not be prescribed or dispensed for use in narcotic addiction treatment, including the treatment of withdrawal symptoms as provided above under the three-day rule.

True/False A patient medication record shall be maintained in the pharmacy for two years.

True A patient medication record system shall be maintained by the pharmacy for patients to whom prescription drug orders are dispensed. (2). The patient medication record system shall provide for the immediate retrieval of information for the previous 12 months which is necessary for the dispensing pharmacist to conduct a prospective drug regimen review at the time a prescription drug order is presented for dispensing. (3). The pharmacist-in-charge shall assure that a reasonable effort is made to obtain and record in the patient medication record at least the following information: (A). full name of the patient for whom the drug is prescribed; (B). address and telephone number of the patient; (C). patient's age or date of birth; (D). patient's gender; (E). any known allergies, drug reactions, idiosyncrasies, and chronic conditions or disease states of the patient and the identity of any other drugs currently being used by the patient which may relate to prospective drug regimen review; (F). pharmacist's comments relevant to the individual's drug therapy, including any other information unique to the specific patient or drug; and (G). a list of all prescription drug orders dispensed (new and refill) to the patient by the pharmacy during the last two years. Such list shall contain the following information: (i). date dispensed; (ii). name, strength, and quantity of the drug dispensed; (iii). prescribing practitioner's name; (iv). unique identification number of the prescription; and (v) name or initials of the dispensing pharmacists. (4). A patient medication record shall be maintained in the pharmacy for two years. If patient medication records are maintained in a data processing system, all of the information specified in this subsection shall be maintained in a retrievable form for two years and information for the previous 12 months shall be maintained on-line. Effective January 1, 2009, a patient medication record must contain documentation of any modification, change, or manipulation to a patient profile.

True/False A pharmacist may dispense a prescription drug order for dangerous drugs issued by practitioners in a state other than Texas.

True A pharmacist may dispense a prescription drug order for dangerous drugs issued by practitioners in a state other than Texas in the same manner as prescription drug orders for dangerous drugs issued by practitioners in Texas are dispensed.

True/False A pharmacist may dispense prescription drug order for Demerol issued by a practitioner in state other than Texas.

True A pharmacist may dispense prescription drug order for controlled substances in Schedule II issued by a practitioner in another state provided: 1. The prescription is filled in compliance with a written plan approved by the Director of the Texas Department of Public Safety in consultation with the Board, which provides the manner in which the dispensing pharmacy may fill a prescription for a Schedule II controlled substance; 2. The prescription drug order is an original written prescription issued by a person practicing in another state and licensed by another state as a physician, dentist, veterinarian, or podiatrist, who has a current federal Drug Enforcement Administration (DEA) registration number, and who may legally prescribe Schedule II controlled substances in such other state; and 3. The prescription drug order is not dispensed after the end of the twenty-first day after the date on which the prescription is issued. Dangerous drug prescription orders: A pharmacist may dispense a prescription drug order for dangerous drugs issued by practitioners in a state other than Texas in the same manner as prescription drug orders for dangerous drugs issued by practitioners in Texas are dispensed. (a). A Schedule II controlled substance prescription issued by a practitioner in another state not on the board's official prescription form may be dispensed if: (1). the practitioner is authorized by the other state to prescribe the substance; (2). the pharmacy has a plan approved by and on file with the board allowing the activity; and (3). the pharmacy processes and submits the prescription according to the reporting requirements approved in the plan.

True/False A pharmacist may permit the delivery of a controlled substance to a patient home by a person known to the pharmacist.

True A pharmacist may permit the delivery of a controlled substance by an authorized delivery person, by a person known to the pharmacist, a pharmacist intern, or the authorized delivery person, or by mail to the person or address of the person authorized by the prescription to receive the controlled substance. If a pharmacist permits delivery of a controlled substance under this subsection, the pharmacist shall retain in the records of the pharmacy for a period of not less than two years: (1). the name of the authorized delivery person, if delivery is made by that person; (2). the name of the person known to the pharmacist, a pharmacist intern, or the authorized delivery person if delivery is made by that person; or (3). the mailing address to which delivery is made, if delivery is made by mail. (n). A pharmacist may permit the delivery of a controlled substance to a person not known to the pharmacist, a pharmacist intern, or the authorized delivery person without first requiring the identification of the person to whom the controlled substance is delivered if the pharmacist determines that an emergency exists and that the controlled substance is needed for the immediate well-being of the patient for whom the controlled substance is prescribed. If a pharmacist permits delivery of a controlled substance under this subsection, the pharmacist shall retain in the records of the pharmacy for a period of not less than two years all information relevant to the delivery known to the pharmacist, including the name, address, and date of birth or age of the person to whom the controlled substance is delivered.

True/False 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.

True 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.

True/False The stocking and retrieval of medications from an automated pharmacy dispensing system shall be limited to licensed healthcare professionals or pharmacy technicians.

True A pharmacy may use an automated pharmacy dispensing system to fill prescription drug orders provided that: (i). the pharmacist-in-charge is responsible for the supervision of the operation of the system; (ii). the automated pharmacy dispensing system has been tested by the pharmacy and found to dispense accurately. The pharmacy shall make the results of such testing available to the board upon request; and (iii). the pharmacy will make the automated pharmacy dispensing system available for inspection by the board for the purpose of validating the accuracy of the system. The stocking and retrieval of medications from an automated pharmacy dispensing system shall be limited to licensed healthcare professionals or pharmacy technicians.

True/False In Texas, a pharmacy shall annually or biennially register each pharmacy balance.

True A pharmacy shall annually or biennially register each pharmacy balance. The expiration date for pharmacy balance registrations shall coincide with the pharmacy license expiration date. The fee for the annual registration shall be $12.50 per pharmacy balance. The fee for the biennial registration shall be $25.00 per pharmacy balance. (1). The Board shall periodically inspect pharmacy balances to verify accuracy. (2). If a pharmacy balance fails the accuracy inspection, the following is applicable. (A). The pharmacy balance may not be used until it is repaired by an authorized repair person. (B). A tag indicating that the pharmacy balance failed the inspection and may not be used shall be placed on the pharmacy balance.

True/False

True A verbal prescription drug order from a practitioner or a practitioner's designated agent may only be received by a pharmacist or a pharmacist-intern under the direct supervision of a pharmacist. A pharmacist may not dispense a verbal prescription drug order for a dangerous drug or a controlled substance issued by a practitioner licensed in the Dominion of Canada or the United Mexican States unless the practitioner is also licensed in Texas. A pharmacist may dispense a verbal prescription drug order issued by a practitioner's designated agent. A practitioner shall designate in writing the name of each agent authorized by the practitioner to communicate prescriptions verbally for the practitioner. The practitioner shall maintain at the practitioner's usual place of business a list of the designated agents. The practitioner shall provide a pharmacist with a copy of the practitioner's written authorization for a specific agent on the pharmacist's request. Similarly, an electronic prescription drug order may be transmitted by a practitioner or a practitioner's designated agent directly to a pharmacy. A practitioner shall designate in writing the name of each agent authorized by the practitioner to electronically transmit prescriptions for the practitioner. The practitioner shall maintain at the practitioner's usual place of business a list of the designated agents. The practitioner shall provide a pharmacist with a copy of the practitioner's written authorization for a specific agent on the pharmacist's request. A pharmacist may dispense an electronic prescription drug order for a Schedule II, III, IV, or V controlled substance in compliance with the federal and state laws and the rules of the Drug Enforcement Administration and Texas Department of Public Safety.

True/False According to Texas State Pharmacy Law, a pre-checked and verified prescription by a pharmacist may be delivered to a patient by a pharmacy technician or pharmacist-intern when a pharmacist is not in the prescription department.

True According to Texas State Pharmacy Law, a pre-checked and verified prescription may be delivered to a patient when a pharmacist is not in the prescription department. However, such dispensing must meet the requirements for a prescription delivered to a patient as described in subsection (c)(1)(F). Subsection (c)(1)(F): if a prescription drug order is delivered to the patient (means dispensing occurs in absence of a pharmacist) or his or her agent at the patient's residence or other designated location, the following is applicable. (i). The information specified in subparagraph (A) of this paragraph shall be delivered with the dispensed prescription in writing. (ii). If prescriptions are routinely delivered outside the area covered by the pharmacy's local telephone service, the pharmacy shall provide a toll-free telephone line which is answered during normal business hours to enable communication between the patient and a pharmacist. (iii). The pharmacist shall place on the prescription container or on a separate sheet delivered with the prescription container in both English and Spanish the local and if applicable, toll-free telephone number of the pharmacy and the statement: "Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at (insert the pharmacy's local and toll-free telephone numbers)." (iv). The pharmacy shall maintain and use adequate storage or shipment containers and use shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of appropriate packaging material and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery process. (v). The pharmacy shall use a delivery system which is designed to assure that the drugs are delivered to the appropriate patient.

True/False When a change in pharmacist employment occurs, the pharmacist shall report such change in writing to the board within 10 days.

True Change of Pharmacist Employment: 1. When a change in pharmacist employment occurs, the pharmacist shall report such change in writing to the board within 10 days. Change of pharmacist-in-charge of a pharmacy: The incoming pharmacist-in-charge shall be responsible for notifying the board within 10 days in writing on a form provided by the board that a change of pharmacist-in-charge has occurred. The notification shall include the following: (A). the name and license number of the departing pharmacist-in-charge; (B). the name and license number of the incoming pharmacist-in-charge; (C). the date the incoming pharmacist-in-charge became the pharmacist-in-charge; and (D). a statement signed by the incoming pharmacist-in-charge attesting that: (i). an inventory, as specified in §291.17 of this title (relating to Inventory Requirements), has been conducted by the departing and incoming pharmacists-in-charge; if the inventory was not taken by both pharmacists, the statement shall provide an explanation; and (ii). the incoming pharmacist-in-charge has read and understands the laws and rules relating to this class of pharmacy.

True/False During the times a pharmacist is absent from the prescription department a pharmacist intern shall be considered a registered pharmacy technician and may perform only the duties of a registered pharmacy technician.

True During the times a pharmacist is absent from the prescription department a pharmacist intern shall be considered a registered pharmacy technician and may perform only the duties of a registered pharmacy technician.

True/False A pharmacist-in-charge of a Class A pharmacy shall inspect medications in the automated pharmacy dispensing system, at least monthly, for expiration date, misbranding, physical integrity, security, and accountability.

True Each Class A pharmacy shall have one pharmacist-in-charge who is employed on a full-time basis, who may be the pharmacist-in-charge for only one such pharmacy; provided, however, such pharmacist-in-charge may be the pharmacist-in-charge of: (i). more than one Class A pharmacy, if the additional Class A pharmacies are not open to provide pharmacy services simultaneously; or (ii). during an emergency, up to two Class A pharmacies open simultaneously if the pharmacist-in-charge works at least 10 hours per week in each pharmacy for no more than a period of 30 consecutive days. The pharmacist-in-charge of the Class A pharmacy shall inspect medications in the automated pharmacy dispensing system, at least monthly, for expiration date, misbranding, physical integrity, security, and accountability.

True/False The dispensing pharmacist must SIGN the official prescription form for a controlled substance before dispensing it.

True Each dispensing pharmacist shall: (1). fill in on the official prescription form or note in the electronic prescription record each item of information given orally to the dispensing pharmacy under Subsection (h) and the date the prescription is filled, and: (A). for a written prescription, fill in the dispensing pharmacist's signature; or (B). for an electronic prescription, appropriately record the identity of the dispensing pharmacist in the electronic prescription record; (2). retain with the records of the pharmacy for at least two years: (A). the official prescription form or the electronic prescription record, as applicable; and (B). the name or other patient identification required by Section 481.074(m) or (n); and (3). send all information required by the director, including any information required to complete an official prescription form or electronic prescription record, to the director by electronic transfer or another form approved by the director not later than the seventh day after the date the prescription is completely filled.

True/False In Texas, a pharmacist may distribute nonprescription Schedule V controlled substances which contain no more than 15 milligrams of opium per 30 ml.

True In Texas, Schedule V controlled substances containing codeine, dihydrocodeine, or any of the salts of codeine or dihydrocodeine may not be distributed without a prescription drug order from a practitioner. A pharmacist may distribute nonprescription Schedule V controlled substances which contain no more than 15 milligrams of opium per 29.5729 ml or per 28.35 Gm provided: (i). such distribution is made only by a pharmacist; a nonpharmacist employee may not distribute a nonprescription Schedule V controlled substance even if under the supervision of a pharmacist; however, after the pharmacist has fulfilled professional and legal responsibilities, the actual cash, credit transaction, or delivery may be completed by a nonpharmacist: (ii). not more than 240 ml (eight fluid ounces), or not more than 48 solid dosage units of any substance containing opium, may be distributed to the same purchaser in any given 48-hour period without a prescription drug order. (iii). the purchaser is at least 18 years of age; and (iv). the pharmacist requires every purchaser not known to the pharmacist to furnish suitable identification (including proof of age where appropriate).

True/False The Board may suspend a pharmacist license if he/she fails to repay a student loan or comply with scholarship service obligations under the Texas Pharmacy Law.

True Sec. 56.003: On receipt of information from an administering entity that a person has defaulted on a student loan or has breached a student loan repayment contract or scholarship contract by failing to perform the person's service obligation under the contract, a licensing authority may: (1). deny the person's application for a license or license renewal; (2). suspend the person's license; or (3). take other disciplinary action against the person.

Within how many days after the date a controlled substance prescription is dispensed, a pharmacy must electronically submit controlled substance prescriptions information to the board?

Within seven days after the date a controlled substance prescription is dispensed, a pharmacy must electronically submit to the board the following data elements from all dispensed controlled substance prescriptions: (1). the prescribing practitioner's DEA registration number including the prescriber's identifying suffix of the authorizing hospital or other institution's DEA number when applicable; (2). the official prescription form control number if dispensed from a written official prescription form, unless the prescription is electronic and meets the requirements of Code of Federal Regulations, Title 21, Part 1311; (3). the board's designated placeholder entered into the control number field if the prescription is electronic; (4). the patient's name, age or date of birth, and address including city, state, and zip code; or such information on the animal's owner if the prescription is for veterinarian services; (5). the date the prescription was issued and dispensed; (6). the NDC # of the controlled substance dispensed; (7). the quantity of controlled substance dispensed; (8). the pharmacy's prescription number; and (9). the pharmacy's DEA registration number.

Can a pharmacy technician or pharmacy technician trainee may restock Pyxis located outside of the pharmacy department with prescription drugs?

Yes (D). Automated medication supply systems used for storage and recordkeeping of medications located outside of the pharmacy department (e.g., Pyxis). A pharmacy technician or pharmacy technician trainee may restock an automated medication supply system located outside of the pharmacy department with prescription drugs provided: (i). prior to distribution of the prescription drugs a pharmacist verifies that the prescription drugs pulled to stock the automated supply system match the list of prescription drugs generated by the automated medication supply system OR (ii). all of the following occur: (I). the prescription drugs to restock the system are labeled and verified with a machine readable product identifier, such as a barcode; (II). either: (-a-). the drugs are in tamper evident product packaging, packaged by an FDA registered repackager or manufacture, that is shipped to the pharmacy; OR (-b-). if any manipulation of the product occurs in the pharmacy prior to restocking, such as repackaging or extemporaneous compounding, the product must be checked by a pharmacist. (E). Recovery Plan: A pharmacy which uses an automated medication supply system to store or distribute medications for administration pursuant to medication orders shall maintain a written plan for recovery from a disaster or any other situation which interrupts the ability of the automated medication supply system to provide services necessary for the operation of the pharmacy. The written plan for recovery shall include: (i). planning and preparation for maintaining pharmacy services when an automated medication supply system is experiencing downtime; (ii). procedures for response when an automated medication supply system is experiencing downtime; (iii). procedures for the maintenance and testing of the written plan for recovery; and (iv). procedures for notification of the Board and other appropriate agencies whenever an automated medication supply system experiences downtime for more than two days of operation or a period of time which significantly limits the pharmacy's ability to provide pharmacy services. (3). Verification of medication orders prepared by the pharmacy department through the use of an automated medication supply system: A pharmacist must check drugs prepared pursuant to medication orders to ensure that the drug is prepared for distribution accurately as prescribed. This paragraph does not apply to automated medication supply systems used for storage and recordkeeping of medications located outside of the pharmacy department. (A). This check shall be considered accomplished if: (i). a check of the final product is conducted by a pharmacist after the automated system has completed preparation of the medication order and prior to delivery to the patient; or (ii). the following checks are conducted by a pharmacist: (I). if the automated medication supply system contains unlabeled stock drugs, a pharmacist verifies that those drugs have been accurately stocked; and (II). a pharmacist checks the accuracy of the data entry of each original or new medication order entered into the automated medication supply system before the order is filled. (B). If the final check is accomplished as specified in subparagraph (A)(ii) of this paragraph, the following additional requirements must be met. (i). The medication order preparation process must be fully automated from the time the pharmacist releases the medication order to the automated system until a completed medication order, ready for delivery to the patient, is produced. (ii). The pharmacy has conducted initial testing and has a continuous quality assurance program which documents that the automated medication supply system dispenses accurately. (iii). The automated medication supply system documents and maintains: (I). the name(s), initials, or identification code(s) of each pharmacist responsible for the checks and (II). the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician or pharmacy technician trainee who performs any other portion of the medication order preparation process. (iv). The pharmacy establishes mechanisms and procedures to test the accuracy of the automated medication supply system at least every month rather than every six months.

Yes/No During the time a pharmacist is absent from the prescription department and is off-site; previously verified prescriptions may be delivered to the patient or the patient's agent.

Yes During the time a pharmacist is absent from the prescription department and is off-site; previously verified prescriptions may be delivered to the patient or the patient's agent, provided the following conditions are met: (I). a notice is posted which includes the following information: (-a-). the pharmacist is off-site and not present in the pharmacy; (-b-). no new prescriptions may be prepared at the pharmacy but previously verified prescriptions may be delivered to the patient or the patient's agent; and (-c-). the date/time when the pharmacist will return.


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