eLaws of Florida

  SECTION 499.05. Rules.  

Latest version.
  • 1(1) 2The department shall adopt rules to implement and enforce this chapter with respect to:
    16(a) 17The definition of terms used in this chapter, and used in the rules adopted under this chapter, when the use of the term is not its usual and ordinary meaning.
    47(b) 48Labeling requirements for drugs, devices, and cosmetics.
    55(c) 56The establishment of fees authorized in this chapter.
    64(d) 65The 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 chapter.
    98(e) 99The application processes and forms for product registration.
    107(f) 108Procedures for requesting and issuing certificates of free sale.
    117(g) 118Inspections and investigations conducted under s. 124499.051 125or s. 127499.93, 128and the identification of information claimed to be a trade secret and exempt from the public records law as provided in s. 150499.051(7)151.
    152(h) 153The establishment of a range of penalties, as provided in s. 164499.066; 165requirements for notifying persons of the potential impact of a violation of this chapter; and a process for the uncontested settlement of alleged violations.
    189(i) 190Additional conditions that qualify as an emergency medical reason under s. 201499.003(53)(b)2202. or s. 205499.82206.
    207(j) 208Procedures and forms relating to the pedigree paper requirement of s. 219499.01212220.
    221(k) 222The 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.
    248(l) 249Information required from each retail establishment pursuant to s. 258499.012(3) 259or s. 261499.83(2)(c), 262including requirements for prescriptions or orders.
    268(m) 269The recordkeeping, storage, and handling with respect to each of the distributions of prescription drugs specified in s. 287499.003(53)(a)288-(d) or s. 291499.82(14)292.
    293(n) 294Alternatives to compliance with s. 299499.01212 300for 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.
    341(o) 342Wholesale distributor reporting requirements of s. 348499.0121(14)349.
    350(p) 351Wholesale distributor credentialing and distribution requirements of s. 359499.0121(15)360.
    361(2) 362With 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.
    389(3) 390The 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; s. 43, ch. 2010-161; s. 19, ch. 2011-141; s. 7, ch. 2014-89.


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).