---
title: O.C.G.A. § 16-13-4. Approval by Food and Drug Administration as prerequisite to sale of controlled substances and dangerous drugs.
collection: code
id: 16-13-4
cite_as: O.C.G.A. § 16-13-4 (2025)
canonical_url: https://georgiacommons.org/code/16-13-4
md_url: https://georgiacommons.org/code/16-13-4.md
text_url: https://georgiacommons.org/code/16-13-4/text
source_url: https://www.legis.ga.gov/api/document/docs/default-source/joint-features-document-library/t16-ch12-17-(v14b)-2024-pdf.pdf?sfvrsn=a591fa7b_0#page=241
date: 2025
status: active
corpus_version: 2025-supplement-89aa39ab3c68
license: CC0-1.0
publisher: Georgia Commons, an independent project of Georgia Civic Data. Not the State of Georgia. Not legal advice.
up: https://georgiacommons.org/code/16-13.md
previous: https://georgiacommons.org/code/16-13-3.md
next: https://georgiacommons.org/code/16-13-5.md
index: https://georgiacommons.org/code/index.md
version: the only printed version
in_force: true
current_through: Including Acts of the 2025 Regular Session of the General Assembly
heading_path: CRIMES AND OFFENSES / CONTROLLED SUBSTANCES / GENERAL PROVISIONS
---

# O.C.G.A. § 16-13-4. Approval by Food and Drug Administration as prerequisite to sale of controlled substances and dangerous drugs.

(a) No controlled substance or dangerous drug shall be sold for dispensing unless the controlled substance, as defined in Code Section 16-13-21, or the dangerous drug, as defined in Code Section 16-13-71:

(1) Is approved by the Food and Drug Administration for resale;

(2) Has a new approved drug application number (known as an NDA number) unless excepted by the Food and Drug Administration; or

(3) Has an approved abbreviated new drug application number (known as an ANDA number) unless excepted by the Food and Drug Administration.

(b) Any person who violates subsection (a) of this Code section shall be guilty of a felony and, upon conviction thereof, shall be punished by imprisonment of not less than one year nor more than five years.

## History

Ga. L. 1981, p. 557, § 6; Ga. L. 1985, p. 1219, § 1; Ga. L. 1989, p. 14, § 16.