TSBP Flashcards

Question 1

Q

Change of address

Answer

A

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.

Question 2

Q

Change of name

Answer

A

(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 license (wall certificate) issued which reflects the pharmacist’s name change, the pharmacist must:
- (A) return the original license (wall certificate); and
- (B) pay a fee of $35.
(3) An amended electronic renewal certificate reflecting the new name of the pharmacist will be issued by the board without a fee.

Question 3

Q

Change of employment

Answer

A

(a) 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.
(b) For the purposes of this section, the term “employment” means the pharmacy at which the pharmacist engages in work on a regular and routine basis, whether remunerative or not, including the practice of pharmacy, administrative or managerial duties, supervisory tasks, or direct or indirect contractual services for pay. The term does not include an isolated case of practicing pharmacy on a temporary basis in order to relieve another pharmacist, unless such isolated cases become regular and routine.

Question 4

Q

Responsibility of Pharmacist

Answer

A

(a) The pharmacist-in-charge shall insure that a pharmacy is in compliance with all state and federal laws and rules governing the practice of pharmacy.(
b) All pharmacists while on duty, shall be responsible for complying with all state and federal laws and rules governing the practice of pharmacy.

Question 5

Q

Sharing Money Received for Prescription

Answer

A

No pharmacist may share or offer to share the money received from a customer for filling a prescription with the practitioner.

Question 6

Q

Pharmacist License or Renewal Fees

Answer

A

(a) Biennial Registration. The Texas State Board of Pharmacy shall require biennial renewal of all pharmacist licenses provided under the Pharmacy Act, §559.002.
(b) Initial License Fee.
- (1) The fee for the initial license shall be $284 for a two year registration.
- (2) New pharmacist licenses shall be assigned an expiration date and initial fee shall be prorated based on the assigned expiration date.
(c) Renewal Fee. The fee for biennial renewal of a pharmacist license shall be $281 for a two year registration.
(d) Exemption from fee. The license of a pharmacist who has been licensed by the Texas State Board of Pharmacy for at least 50 years or who is at least 72 years old shall be renewed without payment of a fee provided such pharmacist is not actively practicing pharmacy. The renewal certificate of such pharmacist issued by the board shall reflect an inactive status. A person whose license is renewed pursuant to this subsection may not engage in the active practice of pharmacy without first paying the renewal fee as set out in subsection (c) of this section.

Question 7

Q

Emergency Temporary Pharmacist License

Answer

A

(a) Definitions. The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.
- (1) Emergency situation–an emergency caused by a natural or manmade disaster or any other exceptional situation that causes an extraordinary demand for pharmacist services.
- (2) State–One of the 50 United States of America, the District of Columbia, and Puerto Rico.
(b) Emergency Temporary Pharmacist license. In an emergency situation, the board may grant a pharmacist who holds a license to practice pharmacy in another state an emergency temporary pharmacist license to practice in Texas. The following is applicable for the emergency temporary pharmacist license.
- (1) An applicant for an emergency temporary pharmacist license under this section must hold a current pharmacist license in another state and that license and other licenses held by the applicant in any other state may not be suspended, revoked, canceled, surrendered, or otherwise restricted for any reason.
- (2) To qualify for an emergency temporary pharmacist license, the applicant must submit an application including the following information:
  - (A) name, address, and phone number of the applicant; and
  - (B) any other information the required by the board.
- (3) An emergency temporary pharmacist license shall be valid for a period as determined by the board not to exceed six months. The executive director of the board, in his/her discretion, may renew the license for an additional six months, if the emergency situation still exists.
(c) Exception. This section is not applicable to pharmacists enrolled in a volunteer health registry maintained by the Texas Department of State Health Services.

Question 8

Q

Pharmacist License Renewal

Answer

A

(1) A license to practice pharmacy expires on the last day of the assigned expiration month (birth month).
(2) Before the expiration date of the license means the receipt in the board’s office of a completed application and renewal fee on or before the last day of the assigned expiration month.
(3) If the completed application and renewal fee is not received on or before the last day of the assigned expiration month, the person’s license to practice pharmacy shall expire. A person shall not practice pharmacy with an expired license. An expired license may be renewed according to the following schedule.
- (A) If license has been expired for 90 days or less, the person may become licensed by making application and paying to the board a renewal fee that is equal to one and one-half times the renewal fee for the license
- (B) If license has been expired for more than 90 days but less than one year, the person may become licensed by making application and paying to the board a renewal fee that is equal to two times the renewal fee for the license as specified in §295.5 of this title.
- (C) If license has been expired for one year or more, the person shall apply for a new license

Question 9

Q

Continuing Education Requirements

Answer

A

(a) Authority and purpose.
- (1) Authority. All pharmacists must complete and report 30 contact hours (3.0 CEUs) of approved continuing education obtained during the previous license period in order to renew their license to practice pharmacy.
- (2) Purpose. The board recognizes that the fundamental purpose of continuing education is to maintain and enhance the professional competency of pharmacists licensed to practice in Texas, for the protection of the health and welfare of the citizens of Texas.
(b) Definitions.
- (1) ACPE–Accreditation Council for Pharmacy Education.
- (2) Act–The Texas Pharmacy Act
- (7) Contact hour–A unit of measure of educational credit which is equivalent to approximately 60 minutes of participation in an organized learning experience.
- (8) Continuing education unit (CEU)–A unit of measure of education credit which is equivalent to 10 contact hours (i.e., one CEU = 10 contact hours).
- (9) CPE Monitor–A collaborative service from the NABP and ACPE that provides an electronic system for pharmacists to track their completed CPE credits.
- (10) Credit hour–A unit of measurement for continuing education equal to 15 contact hours.
(c) Methods for obtaining continuing education. A pharmacist may satisfy the continuing education requirements by either:
- (1) successfully completing the number of continuing education hours necessary to renew a license as specified in subsection (a)(1) of this section; 30 contact hours (3.0 CEUs)
- (2) successfully completing during the preceding license period, one credit hour (equal to 15 contact hours) for each year of their license period (2 year period), which is a part of the professional degree program in a college of pharmacy the professional degree program of which has been accredited by ACPE; or
- (3) taking and passing the standardized pharmacy examination (NAPLEX) during the preceding license period, which shall be equivalent to the number of continuing education hours necessary to renew a license as specified in subsection (a)(1) of this section.

Question 10

Q

Approved CE Programs

Answer

A

(1) Any program presented by an ACPE approved provider subject to the following conditions.
- (A) Pharmacists may receive credit for the completion of the same ACPE course only once during a license period.
- (B) Pharmacists who present approved ACPE continuing education 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 an ACPE 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;
  - (v) the assigned ACPE universal program number and a “P” designation indicating that the CE is targeted to pharmacists; and
  - (vi) either:
    - (I) a dated certifying signature of the approved provider and the official ACPE logo; or
    - (II) the CPE Monitor logo.
(2) Courses which are part of a professional degree program or an advanced pharmacy degree program offered by a college of pharmacy which has a professional degree program accredited by ACPE.
- (A) Pharmacists may receive credit for the completion of the same course only once during a license period.
- (B) Pharmacists who teach these courses may receive credit towards their continuing education, but such credit may be received only once for teaching the same course during a license period.
(3) Basic cardiopulmonary resuscitation (CPR) courses which lead to CPR certification
- one contact hour (0.1 CEU)
- certificate proof
(4) Advanced cardiovascular life support courses (ACLS) or pediatric advanced life support (PALS) courses for initial certification.
- twelve contact hours (1.2 CEUs)
- certificate proof
(5) Advanced cardiovascular life support courses (ACLS) or pediatric advanced life support (PALS) courses which lead to ACLS or PALS recertification
- four contact hours (0.4 CEUs)
- certificate proof
(6) Attendance at Texas State Board of Pharmacy Board Meetings (2 meetings max)
- three contact hours (0.3 CEUs) towards their continuing education requirement for attending a full, public board business meeting in its entirety.
- A maximum of six contact hours (0.6 CEUs) are allowed for attendance at a board meeting during a license period.
- TSBP attendance certificate for proof
(7) Participation in a Texas State Board of Pharmacy appointed Task Force
- three contact hours (0.3 CEUs)
- TSBP certificate proof
(8) Attendance at programs presented by the Texas State Board of Pharmacy or courses offered by the Texas State Board of Pharmacy
- credit for the number of hours for the program or course as stated by TSBP
(9) programs or courses approved by other state boards of pharmacy
- credit for the number of hours for the program or course as specified by the other state board of pharmacy
(10) Completion of an Institute for Safe Medication Practices’ (ISMP) Medication Safety Self Assessment for hospital pharmacies or for community/ambulatory pharmacies
- three contact hours (0.3 CEUs) for completion of an ISMP Medication Safety Self Assessment.
(11) 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
(12) 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
(13) Programs approved by 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.
- credit for the time expended during the actual presentation of the program
  *

Question 11

Q

Retention of continuing education records and audit of records by the board

Answer

A

(1) Retention of records.
- Pharmacists are required to maintain certificates of completion of approved continuing education for three years from the date of reporting the contact hours on a license renewal application. Such records may be maintained in hard copy or electronic format.
(2) Audit of records by the board.
- The board shall audit the records of pharmacists for verification of reported continuing education credit. The following is applicable for such audits.
  - (A) Upon written request, a pharmacist shall provide to the board documentation of proof for all continuing education contact hours reported during a specified license period(s). Failure to provide all requested records during the specified time period constitutes prima facie evidence of failure to keep and maintain records and shall subject the pharmacist to disciplinary action by the board.
  - (B) Credit for continuing education contact hours shall only be allowed for approved programs for which the pharmacist submits documentation of proof reflecting that the hours were completed during the specified license period(s). Any other reported hours shall be disallowed. A pharmacist who has received credit for continuing education contact hours disallowed during an audit shall be subject to disciplinary action.
  - (C) A pharmacist who submits false or fraudulent records to the board shall be subject to disciplinary action by the board.

Question 12

Q

Exemptions from CE reporting

Answer

A

(A) All pharmacists licensed in Texas shall be exempt from the continuing education requirements during their initial license period.
(B) Pharmacists who are not actively practicing pharmacy shall be granted an exemption to the reporting requirements for continuing education provided the pharmacists
- submit a completed renewal application for each license period which states that they are not practicing pharmacy.
- Upon submission of the completed renewal application, the pharmacist shall be issued a renewal certificate which states that pharmacist is inactive.
- Pharmacists who wish to return to the practice of pharmacy after being exempted from the continuing education requirements as specified in this subparagraph must:
  - (i) notify the board of their intent to actively practice pharmacy;
  - (ii) pay the fee as specified in §295.9 of this title (relating to Inactive License); and
  - (iii) provide copies of completion certificates from approved continuing education programs for 30 contact hours (3.0 CEUs). Approved continuing education earned within two years prior to the licensee applying for the return to active status may be applied toward the continuing education requirement for reactivation of the license but may not be counted toward subsequent renewal of the license.

Question 13

Q

CE reporting requirements

Answer

A

(1) Renewal of a pharmacist license.
- 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. The following is applicable to the reporting of continuing education contact hours.
  - (A) For renewals received after January 1, 2015, at least one contact hour (0.1 CEU) shall be related to Texas pharmacy laws or rules.
  - (B) For renewals received after January 1, 2019, at least one contact hour (0.1 CEU) shall be related to opioid abuse.
  - (C) Any continuing education requirements which are imposed upon a pharmacist as a part of a board order or agreed board order shall be in addition to the requirements of this section.
(2) Failure to report completion of required continuing education. The following is applicable if a pharmacist fails to report completion of the required continuing education.
- (A) The license of a pharmacist who fails to report completion of the required number of continuing education contact hours shall not be renewed and the pharmacist shall not be issued a renewal certificate for the license period until such time as the pharmacist successfully completes the required continuing education and reports the completion to the board.
- (B) 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
(3) Extension of time for reporting. A pharmacist who has had a physical disability, illness, or other extenuating circumstances which prohibits the pharmacist from obtaining continuing education credit during the preceding license period may be granted an extension of time to complete the continued education requirement. The following is applicable for this extension:
- (A) The pharmacist shall submit a petition to the board with his/her license renewal application which contains:
  - (i) the name, address, and license number of the pharmacist;
  - (ii) a statement of the reason for the request for extension;
  - (iii) if the reason for the request for extension is health related, a statement from the attending physician(s) treating the pharmacist which includes the nature of the physical disability or illness and the dates the pharmacist was incapacitated; and
  - (iv) if the reason for the request for the extension is for other extenuating circumstances, a detailed explanation of the extenuating circumstances and if because of military deployment, documentation of the dates of the deployment.
- (B) After review and approval of the petition, a pharmacist may be granted an extension of time to comply with the continuing education requirement which shall not exceed one license renewal period.
- (C) An extension of time to complete continuing education credit does not relieve a pharmacist from the continuing education requirement during the current license period.
- (D) If a petition for extension to the reporting period for continuing education is denied, the pharmacist shall:
  - (i) have 60 days to complete and report completion of the required continuing education requirements; and
  - (ii) be subject to the requirements of paragraph (2) of this subsection relating to failure to report completion of the required continuing education if the required continuing education is not completed and reported within the required 60-day time period.

Question 14

Q

Emergency Temporary Pharmacist license

Answer

A

In an emergency situation (natural or manmade disaster or any other exceptional situation that causes an extraordinary demand for pharmacist services), the board may grant a pharmacist who holds a license to practice pharmacy in another state an emergency temporary pharmacist license to practice in Texas. The following is applicable for the emergency temporary pharmacist license.
- (1) An applicant for an emergency temporary pharmacist license under this section must hold a current pharmacist license in another state and that license and other licenses held by the applicant in any other state may not be suspended, revoked, canceled, surrendered, or otherwise restricted for any reason.
- (2) To qualify for an emergency temporary pharmacist license, the applicant must submit an application including the following information:
  - (A) name, address, and phone number of the applicant; and
  - (B) any other information the required by the board.
- (3) An emergency temporary pharmacist license shall be valid for a period as determined by the board not to exceed six months. The executive director of the board, in his/her discretion, may renew the license for an additional six months, if the emergency situation still exists.
(c) Exception. This section is not applicable to pharmacists enrolled in a volunteer health registry maintained by the Texas Department of State Health Services.

Question 15

Q

Inactive License

Answer

A

A person who is licensed by the board to practice pharmacy but who is not eligible to renew the license for failure to comply with the continuing education requirements, and who is not engaged in the practice of pharmacy in this state, may place the license on inactive status at the time of license renewal or during a license period as follows:
- (1) To place a license on inactive status at the time of renewal, the licensee shall:
  - (A) complete and submit before the expiration date a pharmacist license renewal application provided by the board;
  - (B) state on the renewal application that the license is to be placed on inactive status and that the licensee shall not practice pharmacy in Texas while the license is inactive; and
  - (C) pay the fee for renewal of the license
- (2) To place a license on inactive status at a time other than the time of license renewal, the licensee shall:
  - (A) return the current renewal certificate to the board;
  - (B) submit a signed statement stating that the licensee shall not practice pharmacy in Texas while the license is inactive, and the date the license is to be placed on inactive status; and
  - (C) pay the fee for issuance of an amended license
Prohibition against practicing pharmacy in Texas with an inactive license. A holder of a license that is on inactive status shall not practice pharmacy in this state. The practice of pharmacy by a holder of a license that is on inactive status constitutes the practice of pharmacy without a license.
Reactivation of an inactive license.
- (1) A holder of a license that is on inactive status may return the license to active status by:
  - (A) applying for active status on a form prescribed by the board;
  - (B) providing copies of completion certificates from approved continuing education programs for 30 hours including at least one contact hour (0.1 CEU) shall be related to Texas pharmacy laws or rules and at least one contact hour (0.1 CEU) shall be related to opioid abuse. Approved continuing education earned within two years prior to the licensee applying for the return to active status may be applied toward the continuing education requirement for reactivation of the license but may not be counted toward subsequent renewal of the license; and
  - (C) paying the fee specified in paragraph (2) of this subsection.
- (2) If the application for reactivation of the license is made at the time of license renewal, the applicant shall pay the license renewal fee. If the application for reactivation of the license is made at a time other than the time of license renewal, the applicant shall pay the fee for issuance of an amended license to practice pharmacy
- (3) In an emergency caused by a natural or manmade disaster or any other exceptional situation that causes an extraordinary demand for pharmacist services, the executive director of the board, in his/her discretion, may allow a pharmacist whose license has been inactive for no more than two years to reactivate their license prior to obtaining the required continuing education specified in paragraph (1)(B) of this subsection, provided the pharmacist completes the continuing education requirement within six months of reactivation of the license. If the required continuing education is not provided within six months, the license shall return to an inactive status.

Question 16

Q

Notification to Consumers by pharmacist

Answer

A

Every pharmacist who practices pharmacy other than in a licensed pharmacy shall provide notification to consumers of the name, mailing address, internet site address and telephone number of the board for the purpose of directing complaints concerning the practice of pharmacy to the board.
- Such notification shall be provided as follows.
  - (1) If the pharmacist maintains an office and provides pharmacy services to patients who come to the office, the pharmacist shall either:
    - (A) post in a prominent place that is in clear public view where pharmacy services are provided:
      - (i) a sign which notifies the consumer that complaints concerning the practice of pharmacy may be filed with the board and list the board’s mailing address, internet site address, telephone number, and a toll-free telephone number for filing complaints; or
      - (ii) an electronic messaging system in a type size no smaller than ten-point Times Roman which notifies the consumer that complaints concerning the practice of pharmacy may be filed with the board and list the board’s name, mailing address, internet site address, and a toll-free number for filing complaints; or
    - (B) provide to the patient each time pharmacy services are provided a written notification in type size no smaller than ten-point Times Roman which states the following: “Complaints concerning the practice of pharmacy may be filed with the Texas State Board of Pharmacy at: (list the mailing address, internet site address, telephone number of the board, and a toll-free telephone number for filing complaints).”
If the pharmacist provides pharmacy services to patients not at the pharmacist’s office, the pharmacist shall provide to the patient each time pharmacy services are provided, a written notification in type size no smaller than ten-point Times Roman which states the following: “Complaints concerning the practice of pharmacy may be filed with the Texas State Board of Pharmacy at: (list the mailing address, telephone number of the board, internet site address, and a toll-free telephone number for filing complaints).” Such notification shall be included:
- (A) in each written contract for pharmacist services; or
- (B) on each bill for service provided by the pharmacist.
The provisions of this section do not apply to prescriptions for patients in facilities where drugs are administered to patients by a person required to do so by the laws of the state (i.e., nursing homes).

Question 17

Q

Notification to Consumers by TSBP

Answer

A

On or before January 1, 2005, the board shall establish a pharmacist profile system
(1) The board shall make the pharmacist profiles available to the public on the agency’s internet site.
(2) A pharmacist profile shall contain at least the following information:
- (A) pharmacist’s name;
- (B) pharmacist’s license number, licensure status, and expiration date of the license;
- (C) name, address, telephone number, and license number of all Texas pharmacies where the pharmacist works;
- (D) the number of years the person has practiced in Texas;
- (E) professional pharmacy degree held by the licensee, the year it was received, and the name of the institution that awarded the degree;
- (F) whether the pharmacist is preceptor;
- (G) any speciality certification held by the pharmacist; and
- (H) whether the pharmacist has had prior disciplinary action by the board.
(3) The board shall gather this information on initial licensing and update the information in conjunction with the license renewal for the pharmacist.

Question 18

Q

Pharmacist Certification Programs

Answer

A

The board shall recognize as certified, any pharmacist that successfully completes:
- (A) any program offered by an approved provider of pharmacist certificate programs;
- (B) any program that meets the requirements relating to Administration of Immunizations or Vaccinations by a Pharmacist under Written Protocol of a Physician
- (C) any certification offered by the:
  - (i) Board of Pharmaceutical Specialties;
  - (ii) American Society of Consultant Pharmacists;
  - (iii) American Board of Clinical Pharmacology;
  - (iv) American Board of Applied Toxicology; and
  - (v) American Academy of Pain Management; or
- (D) any additional certifications as published on the board’s website.
(2) Texas pharmacists may not identify themselves as certified unless they have completed one of the programs specified in paragraph (1) of this subsection.

Question 19

Q

Drug Therapy Management by a Pharmacist under Written Protocol of a Physician

Answer

A

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;
  - (iv) a statement of the activities the pharmacist shall follow in the course of exercising drug therapy management authority, including the method for documenting decisions made and a plan for communication or feedback to the authorizing physician concerning specific decisions made. Documentation of each intervention will be timely recorded and may be performed on the patient medication record, patient medical chart, or in a separate log book; and
  - (v) a statement of mechanisms and time schedule for the pharmacist to report to the monitoring physician drug therapy management exercised and the occuring results
- (B) A standard protocol may be used or the attending physician may develop a drug therapy management protocol for the individual patient. If a standard protocol is used, the physician shall record what deviations, if any, from the standard protocol are ordered for that patient.

Question 20

Q

Physician delegated drug therapy management

Answer

A

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.
- (2) A delegation under paragraph (1) of this subsection may include the implementation or modification of a patient’s drug therapy under a protocol, including the authority to sign a prescription drug order for dangerous drugs, if:
  - (A) the delegation follows a diagnosis, initial patient assessment, and drug therapy order by the physician;
  - (B) the pharmacist practices in a hospital, hospital-based clinic, or an academic health care institution; and
  - (C) the hospital, hospital-based clinic, or academic health care institution in which the pharmacist practices has bylaws and a medical staff policy that permit a physician to delegate to a pharmacist the management of a patient’s drug therapy.
- (3) A pharmacist who signs a prescription for a dangerous drug under authority granted under paragraph (2) of this subsection shall:
  - (A) notify the board that a physician has delegated the authority to sign a prescription for dangerous drugs. Such notification shall:
    - (i) be made on an application provided by the board;
    - (ii) occur prior to signing any prescription for a dangerous drug;
    - (iii) be updated annually; and
    - (iv) include a copy of the written protocol.
  - (B) include the pharmacist’s name, address, and telephone number as well as the name, address, and telephone number of the delegating physician on each prescription for a dangerous drug signed by the pharmacist.
- (4) The board shall post the following information on its web-site:
  - (A) the name and license number of each pharmacist who has notified the board that a physician has delegated authority to sign a prescription for a dangerous drug;
  - (B) the name and address of the physician who delegated the authority to the pharmacist; and
  - (C) the expiration date of the protocol granting the authority to sign a prescription.

Question 21

Q

Pharmacist Training Requirements for Drug Therapy management

Answer

A

(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.)

Question 22

Q

Drug Therapy Management Supervision

Answer

A

Physician supervision shall be considered adequate if the delegating physician:
- (1) is responsible for the formulation or approval of the written protocol and any patient-specific deviations from the protocol and review of the written protocol and any patient-specific deviations from the protocol at least annually and the services provided to a patient under the protocol on a schedule defined in the written protocol;
- (2) has established and maintains a physician-patient relationship with each patient provided drug therapy management by a delegated pharmacist and informs the patient that drug therapy will be managed by a pharmacist under written protocol;
- (3) is geographically located so as to be able to be physically present daily to provide medical care and supervision;
- (4) receives, on a schedule defined in the written protocol, a periodic status report on the patient, including any problem or complication encountered;
- (5) is available through direct telecommunication for consultation, assistance, and direction; and
- (6) determines that the pharmacist to whom the physician is delegating drug therapy management establishes and maintains a pharmacist-patient relationship with the patient.

Question 23

Q

Drug therapy management records

Answer

A

(1) Maintenance of records.
- (A) 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.
- (B) Records may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:
  - (i) the records maintained in the alternative system contain all of the information required on the manual record; and
  - (ii) the data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.
(2) Written protocol.
- (A) A copy of the written protocol and any patient-specific deviations from the protocol shall be maintained by the pharmacist.
- (B) A pharmacist shall document all interventions undertaken under the written protocol within a reasonable time of each intervention. Documentation may be maintained in the patient medication record, patient medical chart, or in a separate log.
- (C) A standard protocol may be used or the attending physician may develop a drug therapy management protocol for the individual patient. If a standard protocol is used, the physician shall record what deviations, if any, from the standard protocol are ordered for that patient. A pharmacist shall maintain a copy of any deviations from the standard protocol ordered by the physician.
- (D) Written protocols, including standard protocols, any patient-specific deviations from a standard protocol, and any individual patient protocol, shall be reviewed by the physician and pharmacist at least annually and revised if necessary. Such review shall be documented in the pharmacist’s records. Documentation of all services provided to the patient by the pharmacist shall be reviewed by the physician on the schedule established in the protocol.

Question 24

Q

Drug Therapy Management Confidentiality

Answer

A

(1) In addition to the confidentiality requirements specified in §291.27 of this title (relating to Confidentiality) a pharmacist shall comply with:
- (A) the privacy provisions of the federal Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191) and any rules adopted pursuant to this act;
- (B) the requirements of Medical Records Privacy contained in Chapter 181, Health and Safety Code;
- (C) the Privacy of Health Information requirements contained in Chapter 28B of the Insurance Code; and
- (D) any other confidentiality provisions of federal or state laws.
(2) This section shall not affect or alter the provisions relating to the confidentiality of the physician-patient communication as specified in the Medical Practice Act, Chapter 159.

Question 25

Q

Dispensing of Opioid Antagonist by Pharmacist

Answer

A

Opioid antagonist–Any drug that binds to opioid receptors and blocks or otherwise inhibits the effects of opioids acting on those receptors.
- (1) A pharmacist may dispense an opioid antagonist under a valid prescription, including a prescription issued by a standing order, to:
  - (A) a person at risk of experiencing an opioid-related drug overdose; or
  - (B) a family member, friend, or other person in a position to assist a person described by subparagraph (A) of this paragraph.
- (2) A prescription dispensed under this section is considered as dispensed for a legitimate medical purpose in the usual course of professional practice.
- (3) A pharmacist who, acting in good faith and with reasonable care, dispenses or does not dispense an opioid antagonist under a valid prescription is not subject to any criminal or civil liability or any professional disciplinary action for:
  - (A) dispensing or failing to dispense the opioid antagonist; or
  - (B) if the pharmacist chooses to dispense an opioid antagonist, any outcome resulting from the eventual administration of the opioid antagonist.

Question 26

Q

administration of immunizations or vaccinations shall be under the supervision of a physician

Answer

A

Physician supervision shall be considered adequate if the delegating physician:
- (1) is responsible for the formulation or approval of the physician’s order, standing medical order, standing delegation order, or other order or protocol and periodically reviews the order or protocol and the services provided to a patient under the order or protocol;
- (2) has established a physician-patient relationship with each patient under 14 years of age and referred the patient to the pharmacist; except a pharmacist may administer an influenza vaccination to a patient over seven years of age without an established physician-patient relationship;
- (3) is geographically located so as to be easily accessible to the pharmacist administering the immunization or vaccination;
- (4) receives, as appropriate, a periodic status report on the patient, including any problem or complication encountered; and
- (5) is available through direct telecommunication for consultation, assistance, and direction.

Question 27

Q

Pharmacists involved in the administration of immunizations or vaccinations under their license to practice pharmacy

Answer

A

(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.
(3) Pharmacists may administer immunizations or vaccinations under written protocol of a physician within a pharmacy or at any other location specifically identified in the written protocol. Such other location may not include where the patient resides, except for a licensed nursing home or hospital.
(4) The authority of a pharmacist to administer immunizations or vaccinations may not be delegated.
(5) Pharmacists may administer immunizations and vaccinations only when a licensed health-care provider authorized to administer the medication is not reasonably available to administer the medication. For the purpose of this section, “reasonably available” means those times when the licensed health-care provider is immediately available to administer the immunization or vaccine and is specifically tasked to do so.
(6) Under the provisions of the National Vaccine Injury Compensation Program (NVICP), the health-care provider under whose authority a covered vaccine is administered (i.e., the physician issuing the written protocol) must maintain certain information in the patient’s permanent record. In order for the physician to comply with the provisions of the NVICP, the pharmacist shall provide the physician with the information specified in notification of administration
(7) Before preparing an immunization or vaccine and between each patient contact, the pharmacist shall cleanse his or her hands with an alcohol-based waterless antiseptic hand rub or shall wash his or her hands with soap and water. If gloves are worn, the pharmacist shall change gloves between patients.
(8) The pharmacist shall comply with all other state and federal requirements regarding immunizations or vaccinations.

Question 28

Q

immunizations and vaccination possession

Answer

A

(1) Drugs (immunizations and vaccinations) administered by a pharmacist under the provisions of this section shall be in the legal possession of:
- (A) a pharmacy, which shall be the pharmacy responsible for drug accountability, including the maintenance of records of administration of the immunization or vaccination; or
- (B) a physician who shall be responsible for drug accountability, including the maintenance of records of administration of the immunization or vaccination.
(2) Drugs shall be transported and stored at the proper temperatures indicated for each drug.
(3) Pharmacists while actively engaged in the administration of immunizations or vaccinations under written protocol, may have in their custody and control the drugs for immunization or vaccination that are identified in the written protocol and any other dangerous drugs listed in the written protocol to treat adverse reactions.
(4) After administering immunizations or vaccinations at a location other than a pharmacy, the pharmacist shall return all unused prescription medications to the pharmacy or physician responsible for the drugs.

Question 29

Q

Notification of administration of immunizations or vaccinations

Answer

A

(1) A pharmacist engaged in the administration of immunizations or vaccinations shall provide notification of the administration to:
- (A) the physician who issued the written protocol within 24 hours of administering the immunization or vaccination; and
- (B) the primary care physician of the patient, as provided by the patient or patient’s agent, within 14 days of administering the immunization or vaccination.
(2) The notifications required in paragraph (1) of this subsection shall include the:
- (A) name and address of the patient;
- (B) age of the patient if under 14 years of age;
- (C) name of the patient’s primary care physician as provided by the patient or patient’s agent;
- (D) name, manufacturer, and lot number of the vaccine administered;
- (E) amount administered;
- (F) date the vaccine was administered;
- (G) site of the immunization or vaccination (e.g., right arm, left leg, right upper arm);
- (H) route of administration of the immunization or vaccination (e.g., intramuscular, subcutaneous, by mouth); and
- (I) name, address, and title of the person administering the immunization or vaccination.
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.

Question 30

Q

Administration of Epinephrine by a Pharmacist

Answer

A

(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.
(3) Epinephrine administered by a pharmacist under the provisions of this section shall be in the legal possession of a pharmacist or the legal possession of a pharmacy which shall be the pharmacy responsible for drug accountability, including the maintenance of records of administration of the epinephrine.
Limitation on liability.
- (1) A pharmacist who in good faith administers epinephrine through an auto-injector is not liable for civil damages for an act performed in the administration unless the act is willfully or wantonly negligent.
- (2) A pharmacist may not receive remuneration for the administration of epinephrine through an auto-injector but may seek reimbursement for the cost of the epinephrine auto-injector.
- (3) The administration of epinephrine through an auto-injector to a patient does not constitute the unlawful practice of any health care profession.
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 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.(f)
Records.
- (1) 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.
- (2) The notification may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:
  - (A) the records maintained in the alternative system contain all of the information required on the manual record; and
  - (B) the data processing system is capable of producing a hard copy of the record upon request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.

Question 31

Q

Pharmacy technician and technician trainee registration

Answer

A

(1) Individuals who are not registered with the Board may not be employed as or perform the duties of a pharmacy technician or pharmacy technician trainee.
(2) Individuals who have previously applied and registered as a pharmacy technician, regardless of the pharmacy technician’s current registration status, may not register as a pharmacy technician trainee.
(3) Individuals who apply and are qualified for both a pharmacy technician trainee registration and a pharmacy technician registration concurrently will not be considered for a pharmacy technician trainee registration.
(b) Registration for pharmacy technician trainees. An individual may register as a pharmacy technician trainee only once and the registration may not be renewed.
- (1) Each applicant for pharmacy technician trainee 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 purposes of this subparagraph, an applicant for registration may be working to achieve a high school or equivalent diploma for no more than two years;
  - (B) 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.
  - (C) 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.
- (2) Once an applicant has successfully completed all requirements of registration, and the board has determined there are no grounds to refuse registration, the applicant will be notified of registration as a pharmacy technician trainee and of his or her pharmacy technician trainee registration number.
- (3) Pharmacy technician trainee registrations expire two years from the date of registration or upon issuance of registration as a registered pharmacy technician, whichever is earlier.
(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 a pharmacy technician certification 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).
- (2) Once an applicant has successfully completed all requirements of registration, and the board has determined there are no grounds to refuse registration, the applicant will be notified of registration as a registered pharmacy technician and of his or her pharmacy technician registration number. If the pharmacy technician applicant was registered as a pharmacy technician trainee at the time the pharmacy technician registration is issued, the pharmacy technician trainee registration expires.

Question 32

Q

Pharmacy technician registration renewal

Answer

A

(1) All applicants for renewal of a pharmacy technician registration shall:
- (A) complete the Texas application for registration that includes the following information:
  - (i) name;
  - (ii) addresses, phone numbers, date of birth, and social security number;
  - (iii) meet all requirements necessary in order for the Board to access the criminal history record information, including submitting fingerprint information and being responsible for all associated costs; and
  - (iv) any other information requested on the application.
- (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).
(2) A pharmacy technician registration expires on the last day of the assigned expiration month.
(3) As specified in §568.004 of the Act, if the completed application and renewal fee are not received in the board’s office on or before the last day of the assigned expiration month, the person’s pharmacy technician registration shall expire. An expired registration shall be renewed according to the following schedule.
- (A) If a pharmacy technician registration has expired for 90 days or less, the person may become registered by making application and paying to the board a renewal fee that is equal to one and one-half times the renewal fee for the registration
- (B) If a pharmacy technician registration has been expired for more than 90 days but less than one year, the person may become registered by making application and paying to the board a renewal fee that is equal to two times the renewal fee for the registration
- (C) If a pharmacy technician registration has expired for more than one year, the pharmacy technician may not renew the registration and must complete the requirements for initial registration as specified in subsection (c) of this section.
(4) After review, the board may determine that paragraph (3)(C) of this subsection does not apply if the registrant is the subject of a pending investigation or disciplinary action.(e) An individual may use the title “Registered Pharmacy Technician” or “Ph.T.R.” if the individual is registered as a pharmacy technician in this state.

Question 33

Q

Pharmacy technician and trainee fees

Answer

A

(a) Pharmacy technician trainee. The fee for registration shall be $55 for a two-year registration.
(b) Pharmacy technician.
- (1) Biennial Registration. The board shall require biennial renewal of all pharmacy technician registrations provided under Chapter 568 of the Act.
- (2) Initial Registration Fee. The fee for initial registration shall be $83 for a two-year registration.
- (3) Renewal Fee. The fee for biennial renewal shall be $80 for a two-year registration.

Question 34

Q

Pharmacy Technician Trainees

Answer

A

(a) A person designated as a pharmacy technician trainee shall be registered with the board prior to beginning training in a Texas licensed pharmacy.
(b) A person may be designated as a pharmacy technician trainee for no more than two years and the requirements for registration as a pharmacy technician must be completed within the two year period.

Question 35

Q

Pharmacy Technician and Pharmacy Technician Trainee Training

Answer

A

(a) Pharmacy technicians and pharmacy technician trainees shall complete initial training as outlined by the pharmacist-in-chrge in a training manual. Such training:
- (1) shall meet the requirements of subsections (d) or (e) of this section; and
- (2) may not be transferred to another pharmacy unless:
  - (A) the pharmacies are under common ownership and control and have a common training program; and
  - (B) the pharmacist-in-charge of each pharmacy in which the pharmacy technician or pharmacy technician trainee works certifies that the pharmacy technician or pharmacy technician trainee is competent to perform the duties assigned in that pharmacy.
(b) The pharmacist-in-charge shall assure the continuing competency of pharmacy technicians and pharmacy technician trainees through in-service education and training to supplement initial training.
(c) The pharmacist-in-charge shall document the completion of the training program and certify the competency of pharmacy technicians and pharmacy technician trainees completing the training. A written record of initial and in-service training of pharmacy technicians and pharmacy technician trainees shall be maintained and contain the following information:
- (1) name of the person receiving the training;
- (2) date(s) of the training;
- (3) general description of the topics covered;
- (4) a statement that certifies that the pharmacy technician or pharmacy technician trainee is competent to perform the duties assigned;
- (5) name of the person supervising the training; and
- (6) signature of the pharmacy technician or pharmacy technician trainee and the pharmacist-in-charge or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge as responsible for training of pharmacy technicians and pharmacy technician trainees.
(d) A person who has previously completed the training program outlined in subsection (e) of this section, a licensed nurse, or physician assistant is not required to complete the entire training program outlined in subsection (e) of this section if the person is able to show competency through a documented assessment of competency. Such competency assessment may be conducted by personnel designated by the pharmacist-in-charge, but the final acceptance of competency must be approved by the pharmacist-in-charge.
(e) Pharmacy technician and pharmacy technician trainee training shall be outlined in a training manual. Such training manual shall, at a minimum, contain the following:
- (1) written procedures and guidelines for the use and supervision of pharmacy technicians and pharmacy technician trainees. Such procedures and guidelines shall:
  - (A) specify the manner in which the pharmacist responsible for the supervision of pharmacy technicians and pharmacy technician trainees will supervise such personnel and verify the accuracy and completeness of all acts, tasks, and functions performed by such personnel; and
  - (B) specify duties which may and may not be performed by pharmacy technicians and pharmacy technician trainees; and
- (2) instruction in the following areas and any additional areas appropriate to the duties of pharmacy technicians and pharmacy technician trainees in the pharmacy:
  - (A) Orientation;
  - (B) Job descriptions;
  - (C) Communication techniques;
  - (D) Laws and rules;
  - (E) Security and safety;
  - (F) Prescription drugs:
    - (i) Basic pharmaceutical nomenclature;
    - (ii) Dosage forms;
  - (G) Drug orders:
    - (i) Prescribers;
    - (ii) Directions for use;
    - (iii) Commonly-used abbreviations and symbols;
    - (iv) Number of dosage units;
    - (v) Strengths and systems of measurement;
    - (vi) Routes of administration;
    - (vii) Frequency of administration; and
    - (viii) Interpreting directions for use;
  - (H) Drug order preparation:
    - (i) Creating or updating patient medication records;
    - (ii) Entering drug order information into the computer or typing the label in a manual system;
    - (iii) Selecting the correct stock bottle;
    - (iv) Accurately counting or pouring the appropriate quantity of drug product;
    - (v) Selecting the proper container;
    - (vi) Affixing the prescription label;
    - (vii) Affixing auxiliary labels, if indicated; and
    - (viii) Preparing the finished product for inspection and final check by pharmacists;
  - (I) Other functions;
  - (J) Drug product prepackaging;
  - (K) Written policy and guidelines for use of and supervision of pharmacy technicians and pharmacy technician trainees; and
  - (L) Confidential patient medication records.
- (f) Pharmacy technicians and pharmacy technician trainees compounding non-sterile pharmaceuticals shall meet the training and education requirements specified in the rules for the class of pharmacy in which the pharmacy technician or pharmacy technician trainee is working.
- (g) Pharmacy technicians and pharmacy technician trainees compounding sterile pharmaceuticals shall meet the training and education requirements specified in the rules for class of pharmacy in which the pharmacy technician or pharmacy technician trainee is working.

Question 36

Q

Destruction of Dispensed Drugs dispensed to patients in health care facilities or institutions

Answer

A

(a) Drugs dispensed to patients in health care facilities or institutions.
- (1) Destruction by the consultant pharmacist. The consultant pharmacist, if in good standing with the Texas State Board of Pharmacy, is authorized to destroy dangerous drugs dispensed to patients in health care facilities or institutions. A consultant pharmacist may destroy controlled substances as allowed to do so by federal laws or rules of the Drug Enforcement Administration. Dangerous drugs may be destroyed provided 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 following information shall 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 drug destruction;
    - (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 destroying drugs;
    - (ix) signature of the witness(es); and
    - (x) method of destruction.
  - (C) The signature of the consultant pharmacist and witness(es) to the destruction and the method of destruction specified in subparagraph (B) of this paragraph may be on a cover sheet attached to the inventory and not on each individual inventory sheet, provided the cover sheet contains a statement indicating the number of inventory pages that are attached and each of the attached pages are initialed by the consultant pharmacist and witness(es).
  - (D) The drugs are destroyed in a manner to render the drugs unfit for human consumption and disposed of in compliance with all applicable state and federal requirements.
  - (E) 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.
  - (F) If the actual destruction of the drugs is conducted at a location other than the facility or institution, the consultant pharmacist and witness(es) shall retrieve the drugs from the facility or institution, transport, and destroy the drugs at such other location.
(2) Destruction by a waste disposal service. 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 destroy controlled substances as 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.

Question 37

Q

Destruction of drugs returned to a pharmacy

Answer

A

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

Question 38

Q

Disposal of Stock Prescription Drugs

Answer

A

(a) Definition of stock. “Stock” as used in these sections means dangerous drugs or controlled substances which are packaged in the original manufacturer’s container.
(b) Disposal of stock dangerous drugs. A pharmacist, licensed by the board, is authorized to destroy stock dangerous drugs owned by a licensed pharmacy if such dangerous drugs are destroyed in a manner to render the drugs unfit for human consumption and disposed of in compliance with all applicable state and federal requirements.
(c) Disposal of stock controlled substances. A pharmacist, licensed by the board, shall dispose of stock controlled substances owned by a licensed pharmacy in accordance with procedures authorized by the Federal and Texas Controlled Substances Acts and sections adopted pursuant to such Acts.

Question 39

Q

Drug disposal records

Answer

A

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.

Question 40

Q

Controlled Substances:

Official Prescription Form

Answer

A

(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.
(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.

Question 41

Q

Schedule II Prescriptions

Answer

A

(1) Except as provided by subsection (e) of this section, a practitioner, as defined in the TCSA, §481.002(39)(A), must issue a written prescription for a Schedule II controlled substance only on an official Texas prescription form or through an electronic prescription that meets all requirements of the TCSA. This subsection also applies to a prescription issued in an emergency situation.
(2) A practitioner who issues a written prescription for any quantity of a Schedule II controlled substance must complete an official prescription form.
(3) A practitioner may issue multiple written prescriptions authorizing a patient to receive up to a 90-day supply of a Schedule II controlled substance provided:
- (A) each prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice;
- (B) the practitioner provides written instructions on EACH prescription, other than the first prescription if the practitioner intends for that prescription to be filled immediately, indicating the earliest date on which a pharmacy may dispense each prescription; and
- (C) the practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse.
(4) A schedule II prescription must be dispensed no later than 21 days after the date of issuance or, if the prescription is part of a multiple set of prescriptions, issued on the same day, no later than 21 days after the earliest date on which a pharmacy may dispense the prescription as indicated on each prescription.
(e) 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.

Question 42

Q

Schedules III through V Prescriptions

Answer

A

(1) A practitioner, as defined in the TCSA, §481.002(39)(A), (C), (D), may use prescription forms and order forms through individual sources. A practitioner may issue, or allow to be issued by a person under the practitioner’s direction or supervision, a Schedule III through V controlled substance on a prescription form for a valid medical purpose and in the course of medical practice.
(2) Schedule III through V prescriptions may be refilled up to five times within six months after date of issuance.
(c) Electronic prescription. A practitioner is permitted to issue and to dispense an electronic controlled substance prescription only in accordance with the requirements of the Code of Federal Regulations, Title 21, Part 1311.(d) Controlled substance prescriptions may not be postdated.
(e) 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.

Question 43

Q

Official Prescription form exceptions to use

Answer

A

(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.
- (1) A practitioner may dispense or cause to be dispensed a Schedule II controlled substance to a patient who:
  - (A) is admitted to the hospital; and
  - (B) will require an emergency quantity of a controlled substance upon release from the hospital.
- (2) Under paragraph (1) of this subsection, the controlled substance:
  - (A) may only be dispensed in a properly labeled container; and
  - (B) may not be more than a seven-day supply or the minimum amount needed for proper treatment of the patient until the patient can obtain access to a pharmacy, whichever is less.
(b) Subsection (a) of this section applies to a patient who is admitted to a hospital, including a patient:
- (1) admitted to:
  - (A) a general hospital, special hospital, licensed ambulatory surgical center, surgical suite in a dental school, or veterinary medical school; or
  - (B) a hospital clinic or emergency room, if the clinic or emergency room is under the control, direction, and administration as an integral part of a general or special hospital;
- (2) receiving treatment with a Schedule II controlled substance from a member of a Life Flight or similar medical team or an emergency medical ambulance crew or a paramedic-emergency medical technician operating as an extension of an emergency room of a general or special hospital; or
- (3) receiving treatment with a Schedule II controlled substance while the patient is an inmate incarcerated in a correctional facility operated by the Texas Department of Criminal Justice or a correctional facility operating in accordance with the Health Services Plan adopted by the Texas Commission on Jail Standards.
(c) Subsection (a) of this section applies to an animal admitted to an animal hospital, including an animal that is a permanent resident of a zoo, wildlife park, exotic game ranch, wildlife management program, or state or federal research facility.
(d) 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.
(e) 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.

Question 44

Q

Pharmacy General Responsibility

Controlled Substances

Answer

A

(a) Upon receipt of a properly completed prescription form, a dispensing pharmacist must:
- (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 dispensed prior to the earliest date intended by the practitioner nor dispensed beyond 21 days from the earliest date the prescription may be dispensed;
- (3) record the date dispensed 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, record 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 dispensing 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 dispense date; or
- (2) the prescription is for a Schedule III, IV, or V controlled substance, more than six months after issuance or has been dispensed five times during the six months after issuance.

Question 45

Q

Pharmacy Responsibility - Electronic Reporting

Controlled Substances

Answer

A

(a) Not later than the next business day after the date a controlled substance prescription is dispensed, a pharmacy must electronically submit to the board the following data elements:
- (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 for a Schedule II controlled substance;
- (3) the board’s designated placeholder entered into the control number field if the prescription is electronic and meets the requirements of Code of Federal Regulations, Title 21, Part 1311;
- (4) the patient’s name, date of birth, and address including city, state, and zip code; or such information on the animal’s owner if the prescription is for an animal;
- (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.
(b) A pharmacy must electronically correct dispensing data submitted to the board within seven business days of identifying an omission, error, or inaccuracy in previously submitted dispensing data.

Question 46

Q

Pharmacy Responsibility - Oral, Telephonic, or Emergency Prescription

Controlled Substances

Answer

A

(a) If a pharmacy dispenses a controlled substance pursuant to an orally or telephonically communicated prescription from a practitioner or the practitioner’s designated agent, the prescription must be promptly reduced to writing, including the information required:
- (1) by law for a standard prescription; and
- (2) by law and this subchapter for an official prescription, if issued for a Schedule II controlled substance in an emergency situation.
(b) After dispensing a Schedule II controlled substance pursuant to an orally or telephonically communicated prescription, the dispensing pharmacy must:
- (1) maintain the written record created under subsection (a) of this section;
- (2) note the emergency nature of the prescription;
- (3) upon receipt from the practitioner, attach the original official prescription to the orally or telephonically communicated prescription; and
- (4) retain both documents in the pharmacy records.
(c) A pharmacy that dispenses Schedule III, IV, or V controlled substances pursuant to an orally or telephonically communicated prescription must inform the prescribing practitioner in the event of an emergency refill of the prescription.
(d) All records generated under this section must be maintained for two years from the date the substance was dispensed.

Question 47

Q

Pharmacy Responsibility - Modification of Prescription

Controlled Substances

Answer

A

The pharmacy is responsible for documenting the following information regarding a modified prescription:
- (1) date the change or adding of information was authorized;
- (2) information that was authorized to be added or changed;
- (3) name of the prescribing practitioner granting the authorization; and
- (4) initials or identification code of the pharmacist.

Question 48

Q

Pharmacy Responsibility - Out-of-State Practitioner

Controlled Substances

Answer

A

(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.
(b) The pharmacy may dispense a prescription for a Schedule III through V controlled substance issued by a practitioner in another state if the practitioner is authorized by the other state to prescribe the substance.

Question 49

Q

Return of Unused Official Prescription Form

Answer

A

(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 board with an appropriate explanation not later than the 30th day after the date:
- (1) the practitioner’s license to practice, 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 board 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 DEA number or similar number after the individual has been properly and individually licensed as a practitioner by the appropriate state health regulatory agency.

Question 50

Q

Schedule III through V Prescription Forms

Answer

A

(a) A practitioner, as defined in the TCSA, §481.002(39)(A), (C), and (D), may use prescription forms ordered through individual sources or through an electronic prescription that includes the controlled substances registration number issued by the United States Drug Enforcement Administration and meets all requirements of the TCSA.
(b) If a written prescription form is to be used to prescribe a controlled substance the dispensing practitioner must be registered with the DEA under both state and federal law to prescribe controlled substances.

Question 51

Q

Official Prescription Form Accountability

Answer

A

(a) Accountability. A practitioner who obtains from the board an official prescription form is accountable for each numbered form.(
b) Prohibited acts. A practitioner may not:
- (1) allow another practitioner to use the individual practitioner’s official prescription form;
- (2) pre-sign an official prescription blank;
- (3) post-date an official prescription; or
- (4) leave an official prescription blank in a location where the practitioner should reasonably believe another could steal or misuse a prescription.
(c) While not in use. While an official prescription blank is not in immediate use, a practitioner may not maintain or store the book at a location so the book is easily accessible for theft or other misuse.
(d) Voided. A practitioner must account for each voided official prescription form by sending the voided form to the board.(
e) Types of forms. Forms may be single or multiple copy forms as provided by the board.
(f) Faxed forms. Faxed official prescription forms will be accounted for as in the TCSA, §481.074(o).

Question 52

Q

Official Prescription

Lost/found/stolen

Answer

A

(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.

Question 53

Q

Controlled Substances

Access Requirements

Answer

A

(a) Effective September 1, 2019, a pharmacist before dispensing an opioid, benzodiazepine, barbiturate, or carisoprodol for a patient shall consult the Texas Prescription Monitoring Program (PMP) database to review the patient’s controlled substance history. The dispensing pharmacist of a prescription shall be responsible for the review of the PMP database prior to dispensing the prescription, unless the pharmacy has designated another pharmacist whose identity has been recorded in the pharmacy’s data processing system as responsible for PMP review.
(b) The duty to consult the PMP database as described in subsection (a) of this section does not apply in the following circumstances:
- (1) the prescribing individual practitioner is a veterinarian;
- (2) it is clearly noted in the prescription record that the patient has a diagnosis of cancer or is in hospice care; or
- (3) the pharmacist is unable to access the PMP after making and documenting a good faith effort to do so.
(c) If a pharmacist uses pharmacy management systems that integrate data from the PMP, a review of the pharmacy management system with the integrated data shall be deemed compliant with the review of the PMP database as required under §481.0764(a) of the Texas Health and Safety Code and in subsection (a) of this section.
(d) Pharmacists and pharmacy technicians acting at the direction of a pharmacist may only access information contained in the PMP as authorized in §481.076 of Texas Controlled Substances Act. A person who is authorized to access the PMP may only do so utilizing that person’s assigned identifier (i.e., login and password) and may not use the assigned identifier of another person. Unauthorized access of PMP information is a violation of Texas Controlled Substances Act, the Texas Pharmacy Act, and board rules.

Question 54

Q

Prescription substitutions: Texas practitioners

Answer

A

a pharmacist may dispense a generically equivalent drug or interchangeable biological product if:
- (1) the generic drug or interchangeable biological product costs the patient less than the prescribed drug product;
- (2) the patient does not refuse the substitution; and
- (3) the practitioner does not certify on the prescription form that a specific prescribed brand is medically necessary as specified in a dispensing directive described in subsection (c) of this section.
(b) Prescription format for written prescription drug orders.
- (1) A written prescription drug order issued in Texas may:
  - (A) be on a form containing a single signature line for the practitioner; and
  - (B) contain the following reminder statement on the face of the prescription: “A generically equivalent drug product may be dispensed unless the practitioner hand writes the words ‘Brand Necessary’ or ‘Brand Medically Necessary’ on the face of the prescription.”
- (2) A pharmacist may dispense a prescription that is not issued on the form specified in paragraph (1) of this subsection, however, the pharmacist may dispense a generically equivalent drug or interchangeable biological product unless the practitioner has prohibited substitution through a dispensing directive in compliance with subsection (c)(1) of this section.
- (3) The prescription format specified in paragraph (1) of this subsection does not apply to the following types of prescription drug orders:
  - (A) prescription drug orders issued by a practitioner in a state other than Texas;
  - (B) prescriptions for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; or
  - (C) prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment.
- (4) In the event of multiple prescription orders appearing on one prescription form, the practitioner shall clearly identify to which prescription(s) the dispensing directive(s) apply. If the practitioner does not clearly indicate to which prescription(s) the dispensing directive(s) apply, the pharmacist may substitute on all prescriptions on the form.
When a prescription is issued for a brand name product that has no generic equivalent product, the pharmacist must dispense the brand name product. If a generic equivalent or interchangeable biological product becomes available, a pharmacist may substitute the generically equivalent or interchangeable biological product unless the practitioner has specified on the initial prescription that the brand name product is medically necessary.
If the practitioner has prohibited substitution through a dispensing directive in compliance with this subsection, a pharmacist shall not substitute a generically equivalent drug or interchangeable biological product unless the pharmacist obtains verbal or written authorization from the practitioner, notes such authorization on the original prescription drug order, and notifies the patient
Written prescriptions: A practitioner may prohibit the substitution of a generically equivalent drug or interchangeable biological product for a brand name drug product by writing across the face of the written prescription, in the practitioner’s own handwriting, the phrase “brand necessary” or “brand medically necessary.”
- dispensing directive specified in this paragraph may not be preprinted, rubber stamped, or otherwise reproduced on the prescription form.
- A practitioner may prohibit substitution on a written prescription only by following the dispensing directive specified in this paragraph. Two-line prescription forms, check boxes, or other notations on an original prescription drug order which indicate “substitution instructions” are not valid methods to prohibit substitution, and a pharmacist may substitute on these types of written prescriptions.
Verbal prescriptions: must verbally indicate brand medically necessary and pharmacist will reduce to writing.
- If prescription is reimbursed by medical assistance program (medicare):
  - Practitioner must verbally indicate brand necessary AND mail or fax written prescription with directive to pharmacy within 30 days

Question 55

Q

Prescription substitutions:

Out of state practitioners

Answer

A

Prescriptions issued by out-of-state, Mexican, Canadian, or federal facility practitioners.
- (A) The dispensing directive specified in this subsection does not apply to the following types of prescription drug orders:
  - (i) prescription drug orders issued by a practitioner in a state other than Texas;
  - (ii) prescriptions for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; or
  - (iii) prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment.
(B) A pharmacist may not substitute on prescription drug orders identified in subparagraph (A) of this paragraph unless the practitioner has authorized substitution on the prescription drug order. If the practitioner has not authorized substitution on the written prescription drug order, a pharmacist shall not substitute a generically equivalent drug product unless:
- (i) the pharmacist obtains verbal or written authorization from the practitioner (such authorization shall be noted on the original prescription drug order); or
- (ii) the pharmacist obtains written documentation regarding substitution requirements from the State Board of Pharmacy in the state, other than Texas, in which the prescription drug order was issued. The following is applicable concerning this documentation.
  - (I) The documentation shall state that a pharmacist may substitute on a prescription drug order issued in such other state unless the practitioner prohibits substitution on the original prescription drug order.
  - (II) The pharmacist shall note on the original prescription drug order the fact that documentation from such other state board of pharmacy is on file.
  - (III) Such documentation shall be updated yearly.

Question 56

Q

Communication with practitioner:

substitutions

Answer

A

Not later than the third business day after the date of dispensing a biological product, the dispensing pharmacist or the pharmacist’s designee shall communicate to the prescribing practitioner the specific product provided to the patient, including the name of the product and the manufacturer or national drug code number.
(b) The communication must be conveyed by making an entry into an interoperable electronic medical records system or through electronic prescribing technology or a pharmacy benefit management system or a pharmacy record, which may include information submitted for the payment of claims, that a pharmacist reasonably concludes is electronically accessible by the prescribing practitioner. Otherwise, the pharmacist or the pharmacist’s designee shall communicate the biological product dispensed to the prescribing practitioner, using facsimile, telephone, electronic transmission, or other prevailing means, provided that communication is not required if:
- (1) there is no interchangeable biological product approved by the United States Food and Drug Administration for the product prescribed; or
- (2) a refill prescription is not changed from the product dispensed on the prior filling of the prescription.

Question 57

Q

Dispensing Responsibilities:

Substitutions

Answer

A

(a) The determination of the drug product to be substituted as authorized is the professional responsibility of the pharmacist, and the pharmacist may not dispense any product that does not meet the requirements of the Texas Pharmacy Act.
(b) Pharmacists shall use as a basis for the determination of generic equivalency or interchangeability the most recent edition or supplement of the United States Food and Drug Administration’s references (e.g., the Orange Book or Purple Book).
(c) Pharmacists. For drugs not listed in the Orange Book, pharmacists shall use their professional judgment to determine generic equivalency.
(d) Pharmacists shall use Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book) and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication, to determine biosimilarity to or interchangeability with a reference biological product.

Question 58

Q

Pharmaceutically equivalent

Answer

A

Drug products that have identical amounts of the same active chemical ingredients in the same dosage form and that meet the identical compendial or other applicable standards of strength, quality, and purity according to the United States Pharmacopoeia or another nationally recognized compendium

Question 59

Q

Therapeutically equivalent

Answer

A

Pharmaceutically equivalent drug products that, if administered in the same amounts, will provide the same therapeutic effect, identical in duration and intensity.

Question 60

Q

Biosimilar

Answer

A

A biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.

Question 61

Q

Biological product

Answer

A

A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.

Question 62

Q

Question 63

Q

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