The Florida Senate

499.05  Rules.--

(1)  The department shall adopt rules to implement and enforce this part with respect to:

(a)  The definition of terms used in this part, and used in the rules adopted under this part, when the use of the term is not its usual and ordinary meaning.

(b)  Labeling requirements for drugs, devices, and cosmetics.

(c)  The establishment of fees authorized in this part.

(d)  The identification of permits that require an initial application and onsite inspection or other prerequisites for permitting which demonstrate that the establishment and person are in compliance with the requirements of this part.

(e)  The application processes and forms for product registration.

(f)  Procedures for requesting and issuing certificates of free sale.

(g)  Inspections and investigations conducted under s. 499.051, and the identification of information claimed to be a trade secret and exempt from the public records law as provided in s. 499.051(7).

(h)  The establishment of a range of penalties, as provided in s. 499.066; requirements for notifying persons of the potential impact of a violation of this part; and a process for the uncontested settlement of alleged violations.

(i)  Additional conditions that qualify as an emergency medical reason under s. 499.003(53)(b)2.

(j)  Procedures and forms relating to the pedigree paper requirement of s. 499.01212

(k)  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.

(l)  Information required from each retail establishment pursuant to s. 499.012(3), including requirements for prescriptions or orders.

(m)  The recordkeeping, storage, and handling with respect to each of the distributions of prescription drugs specified in s. 499.003(53)(a)-(d).

(n)  Alternatives to compliance with s. 499.01212 for a prescription drug in the inventory of a permitted prescription drug wholesale distributor as of June 30, 2006, and the return of a prescription drug purchased prior to July 1, 2006. The department may specify time limits for such alternatives.

(2)  With respect to products in interstate commerce, those rules must not be inconsistent with rules and regulations of federal agencies unless specifically otherwise directed by the Legislature.

(3)  The department shall adopt rules regulating recordkeeping for and the storage, handling, and distribution of medical devices and over-the-counter drugs to protect the public from adulterated products.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; s. 6, ch. 84-115; s. 88, ch. 85-81; s. 4, ch. 86-133; ss. 17, 18, 36, ch. 92-69; ss. 2, 5, 8, ch. 94-309; ss. 31, 34, 38, ch. 98-151; s. 172, ch. 99-397; ss. 39, 44, ch. 2000-242; s. 20, ch. 2001-63; s. 32, ch. 2001-89; ss. 13, 14, 18, ch. 2003-155; ss. 87, 90, ch. 2004-5; s. 28, ch. 2008-207.

Note.--Paragraph (1)(k) former s. 499.013(3); paragraph (1)(l) former s. 499.0122(2)(b); paragraph (1)(m) former s. 499.012(12).