Code of Alabama - Title 34: Professions and Businesses - Chapter 23 - Pharmacists and Pharmacies

• Article 1 General Provisions.
• Section 34-23-1 Definitions
  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....
• Section 34-23-2 Objects and purposes of chapter
  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...
• Section 34-23-3 State drug investigators
  Each state drug investigator employed by the board following the passage of this chapter must furnish satisfactory proof to the board that he or she...
• Section 34-23-4 Licensure limited to graduates from approved schools and colleges
  The Board of Pharmacy shall consider for licensure graduates from only those schools and colleges of pharmacy which are approved by the board.
• Section 34-23-6 Bankruptcy sales, auction sales, etc., of drugs and medicines
  In the event of any sale in bankruptcy, at public auction or any other sale except in the normal course of business, the seller shall...
• Section 34-23-7 Illegal possession of prescription drugs
  Any person found in possession of a drug or medicine limited by law to dispensation by a prescription, unless such drug or medicine was lawfully...
• Section 34-23-8 Substitution of drugs or brands of drugs
  No person shall dispense or cause to be dispensed a different drug or brand of drug in lieu of that ordered or prescribed without the...
• Section 34-23-8.1 Substitution of certain biological products; notice
  (a) No person shall dispense or cause to be dispensed a different biological or brand of biological product in lieu of that ordered or prescribed...
• Section 34-23-9 Purity of drugs dispensed
  No person shall compound or sell or offer for sale or cause to be compounded, sold, or offered for sale any medicine, drug, poison, chemical,...
• Section 34-23-10 Notification by pharmacists of change of employment
  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...
• Section 34-23-11 Physicians, dentists, registered nurses, etc., exempt from chapter
  (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...
• Section 34-23-12 Injunctions against violations of chapter
  When it shall appear to the board that any person who is not licensed under the provisions of this chapter is violating any of the...
• Section 34-23-13 Penalty for practicing pharmacy without a license; compounding or dispensing prescriptions by unauthorized persons; violations of chapter or rules and regulations of board
  Any person who shall practice pharmacy in this state without having first obtained from the board a license, or who permits prescriptions to be compounded...
• Article 2 Licenses and Permits.
• Division 1 General Provisions.
• Section 34-23-30 Pharmacy permits generally
  (a) Every pharmacy, hospital pharmacy, drugstore, pharmacy department, prescription department, prescription laboratory, dispensary, apothecary, or any other establishment with a title implying the sale, offering...
• Section 34-23-31 Permits for mail-order houses
  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...
• Section 34-23-32 Manufacturer, bottler, packager, repackager, etc., of drugs
  (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...
• Section 34-23-32.1 Adherence to FDA requirements under Federal Prescription Drug 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...
• Section 34-23-32.2 Revocation, suspension, etc., of license or certificate; non-disciplinary administrative penalty
  Any requirements established by the FDA Guidelines in the Drug Quality and Security Act shall be adhered to by the affected parties. The board may...
• Section 34-23-33 Revocation, suspension, etc., of license or certificate; non-disciplinary administrative penalty
  (a) The board may revoke, suspend, place on probation, or require remediation for any licensed pharmacist or a holder of a pharmacy intern or extern...
• Section 34-23-34 Revocation or suspension of licenses to practice pharmacy and pharmacy permits - Statement of charges and notice of hearing
  No action to revoke or suspend the license of any pharmacist or the permit to operate any pharmacy in this state shall be taken until...
• Division 2 Pharmacists' Licenses.
• Section 34-23-50 Required
  (a) It shall be unlawful for any person, firm, or corporation to practice pharmacy in this state or to permit prescriptions to be compounded and/or...
• Section 34-23-51 Application for license; qualifications of applicants; examination of applicants; license by reciprocity
  Every person who desires to practice pharmacy within this state shall file with the secretary of the board his or her written application for licensure...
• Section 34-23-52 Expiration and renewal of certificate; continuing education
  (a) All certificates of licensure shall expire on December 31 of even-numbered years. Every licensed pharmacist in order to continue to be licensed shall pay...
• Section 34-23-53 Training program for candidates for licensure
  Candidates for licensure as pharmacists shall complete a practical training program as prescribed by the board in keeping with standards established by the national accreditation...
• Article 3 Pharmacies.
• Section 34-23-70 Management; display of permit and license; poisons; prescription requirements; violations
  (a) Every pharmacy when opened for business shall be under the personal supervision of a duly licensed pharmacist who shall have personal supervision of not...
• Section 34-23-71 Requirements for prescription rooms
  Any new pharmacy or any existing pharmacy which is to be remodeled or which is to be moved to a new location other than a...
• Section 34-23-72 Internship training sites
  Every site approved by the State Board of Pharmacy for intern training shall be managed so that the intern is provided with ample opportunity to...
• Section 34-23-73 Preceptor qualifications
  Every pharmacist serving as a preceptor shall have expressed a willingness to serve as a preceptor. Pharmacist preceptors shall be approved by the board and...
• Section 34-23-74 Hospitals and related institutions; automated dispensing systems
  (a) Except as otherwise provided in subsection (b), every pharmacy located in a hospital, skilled nursing home, or other related institution in this state shall...
• Section 34-23-75 Emergency prescription refill
  In the event a pharmacist receives a request for a prescription refill and the pharmacist is unable to readily obtain refill authorization from the prescriber,...
• Section 34-23-76 Repackaging, relabeling, and storing of non-controlled legend drugs for certain residential care facility patients
  (a) The Board of Pharmacy may establish by rule protocols allowing a pharmacy in possession of a current retail pharmacy permit to repackage, relabel, and...
• Section 34-23-77 Collaborative practice agreement
  (a) A pharmacist licensed by the Alabama State Board of Pharmacy and a physician licensed by the State Board of Medical Examiners may enter into...
• Article 4 Board of Pharmacy.
• Section 34-23-90 Authority; composition
  (a) The Alabama State Board of Pharmacy is vested with the authority to carry out the purposes of and enforce this chapter. The board shall...
• Section 34-23-91 Duties of officers; bonds of secretary and treasurer; compensation and expenses; meetings; quorum; funds and disbursements; books and records
  The president of the board shall preside at all of the board's meetings. The vice-president shall preside in the absence or inability of the president....
• Section 34-23-92 Powers and duties generally
  The board shall exercise, subject to this chapter, the following powers and duties: (1) To adopt rules concerning the records and reports to be kept...
• Section 34-23-92.1 Legislative findings; rulemaking authority; construction of section
  (a) The Legislature finds and declares all of the following: (1) The power to make rules regulating the practice of pharmacy includes the power to...
• Section 34-23-93 Assisting prosecuting officers; legal counsel
  The board and its members and officers shall assist prosecuting officers in the enforcement of this chapter, and it shall be the duty of the...
• Section 34-23-94 Judicial review of orders
  From any order of the board, any party affected thereby may appeal the ruling to the circuit court of the county where the party aggrieved...
• Article 5 Third Party Prescription Program.
• Section 34-23-110 Short title
  This article shall be known and may be cited as the "Third Party Prescription Program Act."
• Section 34-23-111 "Third Party Prescription Program" defined
  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...
• Section 34-23-112 Required contractual provisions
  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...
• Section 34-23-113 Cancellation of program; use of identity card after cancellation
  (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...
• Section 34-23-114 Denial of payment
  (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...
• Section 34-23-115 Reimbursement rates
  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...
• Section 34-23-116 Article not applicable to certain services
  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,...
• Section 34-23-117 No programs to be instituted until notice given
  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...
• Section 34-23-118 Compliance with article required of all programs
  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...
• Article 6 Pharmacy Technicians.
• Section 34-23-130 Definitions
  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...
• Section 34-23-131 Registration and supervision; rule making authority; continuing 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...
• Section 34-23-132 Revocation or suspension of registration; probation
  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...
• Article 7 Compounding of Drugs.
• Section 34-23-150 Definitions
  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...
• Section 34-23-151 Continuing education; technician assistance; duties of pharmacist
  (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...
• Section 34-23-152 Designation and maintenance of compounding area
  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...
• Section 34-23-153 Use, maintenance, and inspection of compounding equipment
  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...
• Section 34-23-154 Drug components to meet certain requirements
  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...
• Section 34-23-155 Drug product containers and closures
  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...
• Section 34-23-156 Compounding procedures
  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...
• Section 34-23-157 Components transferred to nonoriginal container; advance product 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...
• Section 34-23-158 Retention of records
  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...
• Section 34-23-159 Preparation of compounded drug products for over the counter sale
  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...
• Section 34-23-160 Preparation of compounded drug products for prescriber's office use; 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...
• Section 34-23-161 Prescriptions for animals
  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...
• Section 34-23-162 Rules and regulations
  The board shall promulgate such rules and regulations as are necessary for the implementation, administration, and enforcement of this article.
• Article 8 Pharmacy Audit Integrity Act.
• Section 34-23-180 Short title
  This article shall be known and may be cited as "The Pharmacy Audit Integrity Act."
• Section 34-23-181 Definitions
  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...
• Section 34-23-182 Purpose
  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...
• Section 34-23-183 Application
  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,...
• Section 34-23-184 Audit procedures; report
  (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...
• Section 34-23-185 Appeals
  (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...
• Section 34-23-186 Extrapolation
  (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...
• Section 34-23-187 Fraud, willful misrepresentation, or waste abuse
  This article does not apply to any audit, review, or investigation that involves alleged fraud, willful misrepresentation, or waste abuse.

Last modified: May 3, 2021