Title 34 — Title 34

For the purpose of this chapter, the following words and phrases shall have the following meanings: (1) ASSOCIATION. The Alabama Pharmacy Association. (2) BIOLOGICAL PRODUCT. Has the same meaning as the term as defined in 42 U.S.C. § 262. (3) BOARD or STATE BOARD. The Alabama Sta…

Each pharmacist licensed by the board shall notify the board in writing within 10 days on change of employment. The notice shall contain his or her name, license number, the name of the pharmacy where formerly employed and the name of the pharmacy where currently employed. Histor…

(a) Nothing contained in this chapter shall prevent any licensed practitioner of the healing arts from personally compounding, dispensing, administering, or supplying to his or her patient drugs and medicines for their use. This chapter shall not apply to the manufacture or sale …

This article shall be known and may be cited as the “Third Party Prescription Program Act.” History: (Acts 1981, No. 81-337, p. 477, §1.)

As used in this article, the term “Third Party Prescription Program” shall mean any system of providing for the reimbursement of pharmaceutical services under a contractual arrangement or agreement between a provider of such services and another party who is not the consumer of t…

Any agreement or contract entered into in this state between the program administrator of a third party program and a pharmacy shall include a statement of the method and amount of reimbursement to the pharmacy for services rendered to persons enrolled in the program, the frequen…

(a) The administrator of a program shall notify all pharmacies enrolled in the program of any cancellation of coverage of benefits of any group enrolled in the program at least 30 days prior to the effective date of such cancellation. (b) All persons enrolled in a program shall b…

(a) No program administrator shall deny payment for services to any pharmacy which may have resulted from the fraudulent or illegal use of any identification card by any person unless the pharmacy has been notified that the card has been canceled or discontinued and that the prog…

No agreement between a program administrator and a pharmacy shall establish reimbursement rates or procedures that result in reimbursement rates for services rendered to persons covered by the plan which are less than the usual and customary rates paid by consumers not covered by…

This article shall not apply to any services rendered pursuant to provisions of the Alabama Medicaid Program, to the Public Education Employees’ Health Insurance Plan, or to any corporation organized under the provisions of Title 10, Chapter 4, Article 6, for establishment and op…

After June 27, 1981, no third party prescription programs shall be instituted in this state unless: (1) The program administrator has given written notice of the provisions of the particular program to all pharmacies in this state as defined in Section 34-23-1. (2) All pharmacies…

After June 27, 1981, no third party prescription program shall be instituted, nor shall existing agreement or contract be renewed unless they are in compliance with the provisions of this article. History: (Acts 1981, No. 81-337, p. 477, §11.)

(a) The board may bring an action in the circuit court for an injunction against any person in this state who: (1) Practices pharmacy without a license or permits prescriptions to be compounded or dispensed by a person who is not licensed to practice pharmacy, in violation of Sec…

A person who does any of the following, unless a penalty is otherwise specifically provided in this chapter, is guilty of a Class B misdemeanor: (1) Practices pharmacy in this state without having first obtained a license from the board. (2) Permits prescriptions to be compounded…

As used in this article, the following terms shall have the following meanings: (1) PHARMACY FUNCTIONS. Those functions performed in a pharmacy department which do not require the professional judgment of a licensed pharmacist. (2) PHARMACY TECHNICIAN. An individual, other than a…

Education. (a) A pharmacy technician shall not perform pharmacy functions or be present in the prescription department of a pharmacy unless he or she is under the direct supervision of a licensed pharmacist. A pharmacy technician shall not perform pharmacy functions or be present…

The board shall revoke or suspend the registration of a pharmacy technician or place on probation a pharmacy technician for any of, but not limited to, the following reasons: (1) Willful violation of any provision of this article or the Alabama Uniform Controlled Substances Act. …

As used in this article, the following terms shall have the following meanings: (1) BOARD. The Alabama State Board of Pharmacy. (2) COMPONENT. Any ingredient used in the compounding of a drug product. (3) COMPOUNDING. The preparation, mixing, assembling, packaging, and labeling o…

(a) Any pharmacist who engages in drug compounding shall be proficient in compounding and shall continually expand his or her compounding knowledge by participating in seminars or studying appropriate literature, or both. (b) Pharmacy technicians may assist pharmacists in the pre…

Any pharmacy engaged in compounding shall have a specifically designated and adequate area or space for the orderly compounding of prescriptions. The area used for the compounding of drugs shall be maintained in a good state of repair. The compounding area shall have cleanable su…

Equipment used in the compounding of drug products shall be of appropriate design and capacity, as well as suitably located to facilitate operations for its intended use, cleaning, and maintenance. Compounding equipment shall be of suitable composition so the surfaces that contac…

Pharmacists compounding prescriptions shall use their professional judgment in first receiving, storing, or using drug components that meet official compendia requirements or other high quality sources. Bulk drugs and other chemicals or materials used in the compounding of drugs …

Drug product containers and closures shall be handled and stored in a manner to prevent contamination and to permit inspection and cleaning of the work area. Containers and closures shall be of suitable material in order not to alter the compounded drug as to quality, strength, o…

The board shall establish written procedures for the compounding of drug products to assure that the finished products have the identity, strength, quality, and purity they purport to have or are represented to possess. The procedures shall include, but not be limited to, a listi…

Preparation; Labeling. (a) If a component is transferred from the original container to another container, including, but not limited to, a powder being taken from the original container and stored in another container, the new container shall be identified with the following inf…

Any procedures or other records required to comply with good compounding practices shall be retained for the same period of time as required for retention of prescription records. All records required to be retained under good compounding practices, or copies of such records, sha…

A pharmacy may prepare a compounded drug product to be sold over the counter without a prescription order. The product shall not contain an ingredient which exceeds recommended strengths and doses for over the counter drugs. The finished product shall not be one for which a presc…

Labeling. (a) A pharmacy may prepare a compounded drug product for a prescriber’s office use. An order by a prescriber indicating the formula and quantity ordered shall be filed in the pharmacy. The product shall be administered in the prescriber’s office and shall not be dispens…

Drugs for animals may be compounded based upon an order or prescription. Prescriptions for animals shall be handled and filled in the same manner as are prescriptions for humans. History: (Act 2003-389, p. 1094, §12.)

The board shall promulgate such rules and regulations as are necessary for the implementation, administration, and enforcement of this article. History: (Act 2003-389, p. 1094, §13.)

This article shall be known and may be cited as “The Pharmacy Audit Integrity Act.” History: (Act 2012-306, p. 668, §1.)

The following words shall have the following meanings as used in this article: (1) HEALTH BENEFIT PLAN. Any individual or group plan, employee welfare benefit plan, policy, or contract for health care services issued, delivered, issued for delivery, or renewed in this state by a …

The purpose of this article is to establish minimum and uniform standards and criteria for the audit of pharmacy records by or on behalf of certain entities. History: (Act 2012-306, p. 668, §3.)

This article shall apply to any audit of the records of a pharmacy conducted by a managed care company, nonprofit hospital or medical service organization, health benefit plan, third-party payor, pharmacy benefit manager, a health program administered by a department of the state…

(a) The entity conducting an audit shall follow these procedures: (1) The pharmacy contract shall identify and describe in detail the audit procedures. (2) The entity conducting the on-site audit shall give the pharmacy written notice at least two weeks before conducting the init…

(a) Each entity conducting an audit shall establish a written appeals process under which a pharmacy may appeal an unfavorable preliminary audit report to the entity. (b) Following the appeal, if the entity finds that an unfavorable audit report or any portion thereof is unsubsta…

(a) The auditing entity shall not use extrapolation to calculate penalties or amounts to be charged back or recouped unless otherwise required by federal requirements or federal plans. (b) The auditing entity conducting a pharmacy audit shall not compensate an employee or contrac…

This article does not apply to any audit, review, or investigation that involves alleged fraud, willful misrepresentation, or waste abuse. History: (Act 2012-306, p. 668, §8.)

The practice of pharmacy and the management and operation of pharmacies are hereby declared to affect the public health, safety, and welfare of the people of Alabama, and thereby subject to regulation and control in the public interest. It is further declared to be a matter of pu…

(a) Each state drug investigator employed by the board must furnish satisfactory proof to the board that the investigator is an individual of good moral character and that in the judgment of the members of the board, he or she has sufficient knowledge of the laws pertaining to th…

(a) Every pharmacy, hospital pharmacy, drugstore, pharmacy department, prescription department, prescription laboratory, apothecary, and any other entity with a title implying the sale, offering for sale, compounding, or dispensing of drugs, and any entity providing pharmacy serv…

Every mail-order house which dispenses drugs or medicines through the United States mail or otherwise from any point in the State of Alabama to any point outside of the State of Alabama, and every such business which dispenses drugs or medicines through the United States mail or …

(a) Commencing on August 1, 2017, every manufacturer, bottler, packager, repackager, third party logistic provider, wholesale drug distributor, private label distributor, outsourcing facility, or pharmacy business identified in the supply chain of drugs, medicines, chemicals, or …

Marketing Act of 1987. Any requirements established by the FDA Guidelines, as required by the Federal Prescription Drug Marketing Act of 1987 (PDMA), as amended, specifically addressed in Sections 34-23-1 and 34-23-32, shall be adhered to by the affected parties. History: (Acts 1…

Annual Permits; Fees. (a) Any requirements established by the FDA Guidelines in the Drug Quality and Security Act shall be adhered to by the affected parties. (b)(1) The board may issue an annual permit to any manufacturer, manufacturer affiliate, bottler, packager, repackager, t…

(a) The board may revoke or suspend a license, permit, certificate, or registration, place on probation, require remediation, or impose monetary penalties in accordance with subsection (b) against any person who holds a license, permit, certificate, or registration issued by the …

No disciplinary action described in Section 34-23-33 relating to the license, registration, certificate, or permit of any person regulated by the board may be taken unless a statement of charges and notice of hearing has been served on the person at least 30 days before the date …

The Board of Pharmacy shall consider for licensure graduates from only those schools and colleges of pharmacy which are approved by the board. History: (Acts 1966, Ex. Sess., No. 205, p. 231, §8; Act 2006-296, p. 607, §1.)

Dispensing Controlled Substances. (a) It shall be unlawful for any person, firm, or corporation to practice pharmacy in this state or to permit prescriptions to be compounded or dispensed by a person other than a person duly licensed by the board to practice pharmacy in this stat…

Reciprocity. (a) Every person who desires to practice pharmacy within this state shall file with the secretary of the board his or her application for licensure as required by the board not less than 10 days prior to his or her examination. The application shall be accompanied by…