Part D: Study Notes: Texas Pharmacy Act (TPA)
Texas Pharmacy Act (TPA) Overview
General Provisions
Section 551.001: Short Title
The official title is the "Texas Pharmacy Act".
Section 551.002: Legislative Declaration
The TPA will be interpreted liberally to regulate pharmacy in the public interest.
The practice of pharmacy must maintain public trust and only qualified persons should engage in it.
Purpose of TPA:
Control and regulate pharmacy practice.
License pharmacies involved in prescription drug sales.
Section 551.003: Definitions
Administer: To apply a prescription drug to a patient by authorized individuals (e.g., practitioners or agents).
Board: Refers to the Texas State Board of Pharmacy.
Class Licenses:
Class A: Community pharmacy license
Class B: Nuclear pharmacy license
Class C: Institutional pharmacy license
Class D: Clinic pharmacy license
Class E: Nonresident pharmacy license
Compounding: Preparation and mixing of drugs per a practitioner's prescription or anticipating prescriptions based on observed patterns, or for research and teaching.
Confidential Record: A health-related record maintained by a pharmacy or pharmacist that contains patient-identifying information.
Controlled Substance: Substance listed in Schedules I-V of Texas or federal law.
Dangerous Drug: Drug that is not a controlled substance but is unsafe for self-medication.
Deliver/Delivery: Transfer of prescription drugs or controlled substances from one person to another.
Designated Agent: An individual authorized to communicate prescription drug orders to pharmacisys on behalf of a practitioner.
Dispense: To prepare packages or label drugs in the course of professional practice for delivery to a user.
Drug: A substance for use in diagnosis, treatment, or prevention of disease.
Drug Regimen Review: Evaluation of patient medication records for various interactions and adverse effects.
Internship: A practical experience approved by the Board for pharmacy students.
Label/Labeling: Written or graphic information on drug packaging or labeling processes.
Manufacturing: The production of drugs, including packaging and promotion, which does not include compounding as defined above.
Medication Order: An order from a practitioner or agent for drug administration.
Nonprescription Drug: A drug that can be sold without a prescription, in compliance with regulations.
Patient Counseling: Communication by a pharmacist to improve proper drug use and therapy.
Pharmaceutical Care: Providing drug therapy services defined by Board rules to help patients.
Pharmacist: Licensed individual practicing pharmacy.
Pharmacy/Internal: Place where prescription drugs are received, processed, or dispensed.
Pharmacy Technician: Individual providing technical services under pharmacist supervision.
Practice of Pharmacy: Activities necessary for pharmaceutical care, including dispensing drugs and compounding.
Practitioner: Licensed individuals who can prescribe drugs, including physicians and veterinarians.
Prescription Drug: A drug requiring a prescription before it can be legally dispensed.
Prospective Drug Use Review: Review of drug therapy before dispensing.
Substitution: Dispensing of a different drug or brand from what was prescribed.
Ultimate User: Individual obtaining prescription drugs for personal or household use.
Section 551.004: Applicability of the Act
Excluded from Regulations:
Licensed practitioners providing drugs directly to patients.
Faculty of a pharmacy college providing services for educational purposes.
Individuals conducting lawful research without resale.
Certain health service providers possessing dangerous drugs.
The Act does not prevent practitioners from administering drugs.
Section 551.005: Application of the Sunset Act
The Texas State Board of Pharmacy will expire on September 1, 2029, unless renewed.
Section 551.006: Exclusive Authority
Pharmacists exclusively decide whether to dispense drugs.
Section 551.008: Prohibition on Rule Violating Sincerely Held Religious Belief
Board rules must not violate Texas Religious Freedom Act.
Pharmacists may refuse to dispense certain medications based on religious beliefs, but must check employer policies.
Membership in the State Board of Pharmacy
Section 552.001: Membership
The Board consists of 11 members appointed by the governor: 7 pharmacists, 1 pharmacy technician, and 3 public members.
Section 552.002: Qualifications
Board members must reside in Texas, have relevant experience, and be in good standing with pharmacy practice.
Section 552.003: Public Member Eligibility
Restrictions apply to prevent conflicts of interest for public members.
Section 552.004: Membership Restrictions
No lobbyists or trade association employees may become Board members.
Section 552.005: Terms; Vacancy
Members serve staggered six-year terms; cannot serve more than two consecutive full terms.
Section 552.006: Board Member Training
New members must complete a Board training program.
Section 552.007: Officers
Officers elected by the Board must fulfill specific duties related to Board functions.
Section 552.008: Grounds for Removal
Grounds include lack of qualifications, violation of prohibitions, or poor attendance.
Section 552.009: Per Diem; Reimbursement
Members receive per diem and travel expense reimbursements.
Section 552.010: Meetings
Meetings occur at least every four months, and additional meetings can be called as needed.
Section 552.011: Executive Session
Certain matters can be discussed in private sessions subject to regulations.
Section 552.012: Quorum; Validity of Board Action
Majority rules constitute a quorum for Board actions.
Executive Director and Board Personnel
Section 553.001: Executive Director
The Board employs an ex officio executive director for administrative purposes.
Section 553.002: Qualifications of the Executive Director
The executive director must be a licensed pharmacist.
Section 553.003: General Duties of the Executive Director
Duties include serving as secretary and performing administrative functions, but not decision-making responsibilities.
Section 553.004: Personnel
Board can employ necessary personnel for operations.
Section 553.006: Possession By Employee of a Regulated Substance
Employees may possess dangerous drugs or controlled substances in an official capacity.
Board Powers and Duties; Rulemaking Authority
Section 554.001: General Powers and Duties of the Board
The Board administers the TPA and related laws, can issue licenses, and maintain records.
Section 554.002: Regulation of the Practice of Pharmacy
The Board regulates pharmacy practice, licensing, and standards for schools.
Section 554.003: Procedures
The Board specifies licensing procedures and fees.
Section 554.004: Administration of Medication
Conditions for pharmacists to administer medications are outlined.
Section 554.005: Prescription Drugs and Devices
The Board regulates prescription delivery and dispensing standards while ensuring record maintenance.
Section 554.006-554.010: Fees, Funds, Surety Bonds
Other pertinent financial details related to Board functions.
Section 554.011: Pilot and Demonstration Research Projects
Approval procedures for any research projects must ensure public health safety and not expand the pharmacy definition.
Procedures for applying entail detailed project proposals and justification for rule waivers.
Immunizations and Vaccinations
Section 554.052: Immunizations and Vaccinations; Physician Supervision
Program and requirements for pharmacists administering immunizations, requiring written protocols.
Notifications for Immunizations
Pharmacists must notify prescribing physicians after administering an immunization.
Pharmacist Interns
Section 557.001: Pharmacist Intern Registration
Interns must register with the Board before starting an internship.
Section 558: License to Practice Pharmacy
The necessity of obtaining a license to practice and the consequences of holding oneself as a pharmacist without licensure.
Examination Requirements
Candidates must pass NAPLEX and Texas MPJE, including retake provisions.
Criminal History Evaluation Letter
Outlines process for prospective pharmacists with past legal issues.