Drug manufacturers, wholesalers, distributors, and other pharmacy stakeholders are required to maintain certain legal standards regarding safety and security of their facilities to ensure the health and safety of the public. These facilities are required to develop and maintain compliance with policies and procedures related to the receipt, security, storage, inventory, and distribution of drugs. Certain facilities are required to designate a representative who is responsible for maintaining compliance, while others are required to have an Alabama-licensed pharmacist serve in the role of supervising pharmacist at the site. Additionally, facilities are required to keep records regarding the receipt and/or distribution of drugs, including inventory and all transactions. Facilities who do not maintain compliance with the rules and regulations risk their permit being revoked, suspended, put on probation, or denied and may be subject to fines. Some facilities manufacture, sell, or purchase precursor chemicals, which are chemicals or solvents that are used to manufacture controlled substances. These facilities are required to obtain a license with the ALBOP as well as a permit each time one is used.

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Requirements of Manufacturers, Wholesalers, Distributors, and Other Pharmacy Stakeholders

  • Marilyn N. Bulloch,
  • Scott Penzak,
  • Lena McDowell

摘要

Drug manufacturers, wholesalers, distributors, and other pharmacy stakeholders are required to maintain certain legal standards regarding safety and security of their facilities to ensure the health and safety of the public. These facilities are required to develop and maintain compliance with policies and procedures related to the receipt, security, storage, inventory, and distribution of drugs. Certain facilities are required to designate a representative who is responsible for maintaining compliance, while others are required to have an Alabama-licensed pharmacist serve in the role of supervising pharmacist at the site. Additionally, facilities are required to keep records regarding the receipt and/or distribution of drugs, including inventory and all transactions. Facilities who do not maintain compliance with the rules and regulations risk their permit being revoked, suspended, put on probation, or denied and may be subject to fines. Some facilities manufacture, sell, or purchase precursor chemicals, which are chemicals or solvents that are used to manufacture controlled substances. These facilities are required to obtain a license with the ALBOP as well as a permit each time one is used.