The Florida Senate

499.013  Manufacturers and repackagers of drugs, devices, and cosmetics; definitions, permits, and general requirements.--

(1)  As used in this section, the terms "manufacture" and "repackage" have the meaning as in s. 499.003 A pharmacy is exempt from these definitions if it is operating in compliance with pharmacy practice standards as defined in chapter 465 and the rules adopted under that chapter.

(2)  Any person that engages in the manufacture or repackaging 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:

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

1.  A person that operates an establishment permitted as a prescription drug manufacturer or prescription drug repackager may engage in wholesale distribution of prescription drugs manufactured or repackaged 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 or prescription drug repackager must comply with all appropriate state and federal good manufacturing practices.

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

(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.

(d)  A device manufacturer's permit is required for any person that engages in the manufacture, repackaging, or assembly of medical devices for human use in this state, except that a permit is not required if the person is engaged only in manufacturing, repackaging, or assembling a medical device pursuant to a practitioner's order for a specific patient.

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

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

(e)  A cosmetic manufacturer's permit is required for any person that manufactures or repackages 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)  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 and repackagers must follow to ensure the safety of the products.

(4)  Each manufacturer or repackager of medical devices, over-the-counter drugs, or cosmetics must maintain records that include the name and principal address of the seller or transferor of the product, the address of the location from which the product was shipped, the date of the transaction, the name and quantity of the product involved, and the name and principal address of the person who purchased the product.

History.--s. 18, ch. 92-69; s. 34, ch. 98-151; s. 40, ch. 2000-242; s. 18, ch. 2003-155.