(a) No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug unless:
(1) An application with respect thereto has become effective under Section 505 of the federal act; or
(2) When not subject to the federal act unless such drug has been tested and has not been found to be unsafe for use under the conditions prescribed, recommended, or suggested in the labeling thereof and prior to selling or offering such drug for sale, there has been filed with the State Board of Pharmacy an application setting forth:
(A) Full reports of investigations which have been made to show whether or not such drug is safe for use;
(B) A full list of the articles used as components of such drug;
(C) A full statement of the composition of such drug;
(D) A full description of the methods used in and the facilities and controls used for the manufacture, processing, and packing of such drug;
(E) Such samples of such drug and of the articles used as components thereof as the State Board of Pharmacy may require; and
(F) Specimens of the labeling proposed to be used for such drug.
(b) An application provided for in paragraph (2) of subsection (a) of this Code section shall become effective 60 days after the filing thereof, except that if the State Board of Pharmacy finds after due notice to the applicant and after giving him an opportunity for a hearing that the drug is not safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, he shall prior to the effective date of the application issue an order refusing to permit the application to become effective.
(c) This Code section shall not apply:
(1) To a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety in drugs, provided the drug is plainly labeled "For investigational use only"; or
(2) To a drug sold in the state at any time prior to the enactment of this chapter or introduced into interstate commerce at any time prior to the enactment of the federal act; or
(3) To any drug manufactured, labeled, and sold for veterinary purposes.
(d) An order refusing to permit an application under this Code section to become effective may be revoked by the State Board of Pharmacy.
Copyright ©2024 LegalFix. All rights reserved. LegalFix is not a law firm, is not licensed to practice law, and does not provide legal advice, services, or representation. The information on this website is an overview of the legal plans you can purchase—or that may be provided by your employer as an employee benefit or by your credit union or other membership group as a membership benefit.
LegalFix provides its members with easy access to affordable legal services through a network of independent law firms. LegalFix, its corporate entity, and its officers, directors, employees, agents, and contractors do not provide legal advice, services, or representation—directly or indirectly.
The articles and information on the site are not legal advice and should not be relied upon—they are for information purposes only. You should become a LegalFix member to get legal services from one of our network law firms.
You should not disclose confidential or potentially incriminating information to LegalFix—you should only communicate such information to your network law firm.
The benefits and legal services described in the LegalFix legal plans are not always available in all states or with all plans. See the legal plan Benefit Overview and the more comprehensive legal plan contract during checkout for coverage details in your state.
Use of this website, the purchase of legal plans, and access to the LegalFix networks of law firms are subject to the LegalFix Terms of Service and Privacy Policy.