This text of Alabama § 34-23-32 (Manufacturer, Bottler, Packager, Repackager, Etc., of Drugs) is published on Counsel Stack Legal Research, covering Alabama primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
(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 poisons for medicinal purposes shall register annually with the board by application for a permit on a form furnished by the board and accompanied by a fee to be determined by the board as follows:
(1)The fee shall not be less than five hundred dollars ($500) nor more than two thousand dollars ($2,000) for a new establishment.
(2)The fee shall not be less than two hundred fifty dollars ($250) nor more than one thousand dollars ($1,000) for a renewal permit.
(3)The fee shall not be less than five hundred dollars
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(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 poisons for medicinal purposes shall register annually with the board by application for a permit on a form furnished by the board and accompanied by a fee to be determined by the board as follows:
(1) The fee shall not be less than five hundred dollars ($500) nor more than two thousand dollars ($2,000) for a new establishment.
(2) The fee shall not be less than two hundred fifty dollars ($250) nor more than one thousand dollars ($1,000) for a renewal permit.
(3) The fee shall not be less than five hundred dollars ($500) nor more than two thousand dollars ($2,000) for a permit due to transfer of ownership.
(b) A holder of a permit shall employ a full-time licensed pharmacist whose principal duty shall be confined to on-premise pharmaceutical operations. Wholesale drug distributors who strictly limit their operation to distribution of drugs, medicines, chemicals, or poisons for medicinal purposes are exempt from the requirement to employ a full-time licensed pharmacist.
(c) The professional practice of any physician licensed to practice medicine is exempt from the requirements of this section.
(d) All permits issued under this section shall become due on October 31 and shall become null and void if not paid by December 31. Each application for the renewal of the permit shall be made annually on or before December 31. A penalty of one hundred dollars ($100) for each overdue month shall be assessed in addition to the permit fee for renewal of delinquent permits.
(e)(1) Commencing on January 1, 2024, each holder of a permit issued under this section, with the exception of an outsourcing facility, shall designate a current representative of the permit holder and shall register the designated representative with the board. The designated representative shall possess the qualifications, requirements, and background as set out by the board.
(2) The holder of the permit shall pay an initial registration fee to register the designated representative of not less than one hundred dollars ($100), as set by rule of the board. The registration of a designated representative shall expire on December 31. The renewal of the registration shall be due on October 31 of each year and shall be delinquent after December 31. The annual fee for the renewal of a designated representative shall not be less than one hundred dollars ($100), as set by rule of the board. If the renewal is not timely received by the board, the applicant for renewal of the registration shall pay a penalty of not more than fifty dollars ($50) for each month the renewal is late, as set by rule of the board.
(f) All holders of a permit, before shipping any drug bearing the legend, “caution, federal law prohibits dispensing without prescription” or similar wording causing these drugs to be known as legend drugs to new customers, shall assure themselves that the recipient is either a duly licensed doctor of medicine, dentistry, or veterinary medicine or holds a registered pharmacy permit from the board by contacting the office of the board.
(g) No manufacturer, manufacturer affiliate, bottler, packager, repackager, third party logistic provider, wholesale drug distributor, private label distributor, outsourcing facility, or pharmacy business identified in the supply chain of any legend drug or device shall ship, or cause to be shipped, into the state any legend drug or device without a valid permit issued by the board. The civil penalty for a violation of this subsection shall be four thousand dollars ($4,000) for each violation.
(h) The holder of a permit to ship any legend drug or device into the state shall provide to the board a list of all trading partners, upon request of the board.
(i) No holder of a permit shall ship any legend drug to any person or firm after receiving written notice from the board that the person or firm no longer holds a registered pharmacy permit. Any person violating this section shall be guilty of a misdemeanor.
(j) For each application for a permit found to be satisfactory by the board, the secretary of the board shall issue to the applicant a permit for the appropriate function, which permit shall be displayed in a conspicuous place.