Florida Statute 499.05 | Lawyer Caselaw & Research

The 2024 Florida Statutes

Title XXXIII
REGULATION OF TRADE, COMMERCE, INVESTMENTS, AND SOLICITATIONS

Chapter 499
FLORIDA DRUG AND COSMETIC ACT

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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.

(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

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Amendments to 499.05

Arrestable Offenses / Crimes under Fla. Stat. 499.05

Level: Degree
Misdemeanor/Felony: First/Second/Third

Current data shows no reason an arrest or criminal charge should have occurred directly under Florida Statute 499.05.

Annotations, Discussions, Cases:

Cases Citing Statute 499.05

Total Results: 7

Bio-Med Plus v. STATE, DEPT. OF HEALTH

Court: Fla. Dist. Ct. App. | Date Filed: 2005-10-20T00:53:00-07:00

Citation: 915 So. 2d 669

Snippet: prescription drugs for resale in violation of s. 499.005, (23), F.S. 9. ... Bio-Med Plus acquired prescription…defined in s. 499.006, F.S., in violation of s. 499.005(1) and (4), F.S., because the prescription drugs…adopted under those sections in violation of s. 499.005(18), F.S. 11. Based on the indictment, Bio-Med

Amendments to Florida Rules of Criminal Procedure re Sentencing Guidelines

Court: Fla. | Date Filed: 1993-11-30T00:00:00-08:00

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

Snippet: 817, 831, and 832. Category 7: Drugs: Section 499.005 and chapter 893. Category 8: Weapons: Chapter 790

Amendments to Florida Rules of Criminal Procedure

Court: Fla. | Date Filed: 1993-02-11T00:00:00-08:00

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

Snippet: violations of new *1308subsections of section 499.005, Florida Statutes, relating to the regulation of… 817, 831, and 832. Category 7: Drugs: Section 499.005 and Cchapter 893. Other amended statutes are already…] *1315Rule 3.988(g) Category 7: Drugs Section 499.005 — Regulation of Drugs and Cosmetics Chapter 893

Ago

Court: Fla. Att'y Gen. | Date Filed: 1990-04-11T00:53:00-07:00

Snippet: Services conduct warrantless searches pursuant to ss. 499.005, 499.051 and 499.069, F.S.? In sum: It has been…to conduct warrantless searches pursuant to ss. 499.005, 499.051 and 499.069, F.S., as directed by Rule…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

Court: Fla. Dist. Ct. App. | Date Filed: 1989-05-31T00:00:00-07:00

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

Snippet: total fine of $10,000 for violations of section 499.005(6), Florida *1305Statutes (1987) and rule 10D-45.0545

Miller Elec. Co. v. EMPLOYERS'LIABILITY ASSUR. CORP.

Court: Fla. Dist. Ct. App. | Date Filed: 1965-01-13T23:53:00-08:00

Citation: 171 So. 2d 40

Snippet: San Francisco, Cal. v. Boyd (Fla. 1950) 45 So.2d 499. [5] Beasley v. Wolf (Fla.App. 1963) 151 So.2d 679

Dunscombe v. Smith

Court: Fla. | Date Filed: 1939-07-25T00:00:00-08:00

Citation: 190 So. 796, 139 Fla. 497, 1939 Fla. LEXIS 1693

Snippet: Company had been completely liquidated and *Page 499 $5,900.00 was in hand applicable to the claims of