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Florida Statute 499.05 - Full Text and Legal Analysis
Florida Statute 499.05 | Lawyer Caselaw & Research
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The 2025 Florida Statutes

Title XXXIII
REGULATION OF TRADE, COMMERCE, INVESTMENTS, AND SOLICITATIONS
Chapter 499
FLORIDA DRUG AND COSMETIC ACT
View Entire Chapter
F.S. 499.05
499.05 Rules.
(1) The department shall adopt rules to implement and enforce this chapter with respect to:
(a) The 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.
(b) Labeling requirements for drugs, devices, and cosmetics.
(c) The establishment of fees authorized in this chapter.
(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 chapter.
(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 or s. 499.93, 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 chapter; and a process for the uncontested settlement of alleged violations.
(i) Additional conditions that qualify as an emergency medical reason under s. 499.003(48)(b)2. or s. 499.82.
(j) 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.
(k) Information required from each retail establishment pursuant to s. 499.012(3) or s. 499.83(2)(c), including requirements for prescriptions or orders.
(l) The recordkeeping, storage, and handling with respect to each of the distributions of prescription drugs specified in s. 499.003(48)(a)-(v) or s. 499.82(14).
(m) Wholesale distributor reporting requirements of s. 499.0121(14).
(n) Wholesale distributor credentialing and distribution requirements of s. 499.0121(15).
(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; s. 43, ch. 2010-161; s. 19, ch. 2011-141; s. 7, ch. 2014-89; s. 12, ch. 2016-212.
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).

F.S. 499.05 on Google Scholar

F.S. 499.05 on CourtListener

Amendments to 499.05


Annotations, Discussions, Cases:

Cases Citing Statute 499.05

Total Results: 4

Amendments to Florida Rules of Criminal Procedure re Sentencing Guidelines

628 So. 2d 1084, 18 Fla. L. Weekly Supp. 617, 1993 Fla. LEXIS 1928, 1993 WL 490876

Supreme Court of Florida | Filed: Nov 30, 1993 | Docket: 64744908

Published

815, 817, 831, and 832. Category 7: Drugs: Section 499.005 and chapter 893. Category 8: Weapons: Chapter

Amendments to Florida Rules of Criminal Procedure

613 So. 2d 1307, 18 Fla. L. Weekly Supp. 113, 1993 Fla. LEXIS 172, 1993 WL 32299

Supreme Court of Florida | Filed: Feb 11, 1993 | Docket: 64694361

Published

that violations of new *1308subsections of section 499.005, Florida Statutes, relating to the regulation

Ago

Florida Attorney General Reports | Filed: Apr 11, 1990 | Docket: 3258395

Published

with the provisions in Part II, Ch. 499, F.S. Section 499.005, F.S., sets forth those acts which are prohibited

Arthritis Medical Center, Inc. v. Department of Health & Rehabilitative Services

543 So. 2d 1304, 14 Fla. L. Weekly 1329, 1989 Fla. App. LEXIS 3054, 1989 WL 55974

District Court of Appeal of Florida | Filed: May 31, 1989 | Docket: 64642792

Published

a total fine of $10,000 for violations of section 499.005(6), Florida *1305Statutes (1987) and rule 10D-45