1. (1) As used in this section, the term "manufacture" has the meaning assigned to it under s. 499.003. A pharmacy is exempt from this definition if it is operating in compliance with pharmacy practice standards as defined in chapter 465 and the rules adopted under that chapter.

2. (2) Any person that engages in the manufacture of drugs, devices, or cosmetics in this state must first obtain one of the following permits and may engage only in the activity allowed under that permit:

   1. (a) A prescription drug manufacturer's permit is required for any person that manufactures a prescription drug in this state.

      1. A person that operates an establishment permitted as a prescription drug manufacturer may engage in wholesale distribution of prescription drugs manufactured at that establishment and must comply with all the provisions of ss. 499.001-499.081 and the rules adopted under those sections that apply to a wholesale distributor.

      2. A prescription drug manufacturer permittee must comply with all appropriate state and federal good manufacturing practices.

   2. (b) An over-the-counter drug manufacturer's permit is required for any person that engages in the manufacture of an over-the-counter drug.

      1. An over-the-counter drug manufacturer permittee may not possess or purchase prescription drugs.

      2. A pharmacy is exempt from obtaining an over-the-counter drug manufacturer's permit if it is operating in compliance with pharmacy practice standards as defined in chapter 465 and the rules adopted under that chapter.

      3. An over-the-counter drug manufacturer permittee must comply with all appropriate state and federal good manufacturing practices.

   3. (c) A compressed medical gas manufacturer's permit is required for any person that engages in the manufacture of compressed medical gases or repackages compressed medical gases from one container to another.

      1. A compressed medical gas manufacturer permittee may not manufacture or possess any prescription drug other than compressed medical gases.

      2. A compressed medical gas manufacturer permittee may engage in wholesale distribution of compressed medical gases manufactured at that establishment and must comply with all the provisions of ss. 499.001-499.081 and the rules adopted under those sections that apply to a wholesale distributor.

      3. A compressed medical gas manufacturer permittee must comply with all appropriate state and federal good manufacturing practices.

   4. (d) A device manufacturer's permit is required for any person that engages in the manufacture or assembly of medical devices for human use in this state.

      1. A manufacturer of medical devices in this state must comply with all appropriate state and federal good manufacturing practices.

      2. The department shall adopt rules related to storage, handling, and recordkeeping requirements for manufacturers of medical devices for human use.

   5. (e) A cosmetic manufacturer's permit is required for any person that manufactures cosmetics in this state. A person that only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product is exempt from obtaining a permit under this paragraph.
3. (3) The department may adopt such rules as are necessary for the protection of the public health, safety, and welfare regarding good manufacturing practices that manufacturers must follow to ensure the safety of the products.

History.--s. 18, ch. 92-69; s. 34, ch. 98-151.