PART 310—NEW DRUGS

PART 310—NEW DRUGS

§ 310.3 - Definitions and interpretations.
§ 310.4 - Biologics; products subject to license control.
§ 310.6 - Applicability of “new drug” or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products.
§ 310.100 - New drug status opinions; statement of policy.
§ 310.103 - New drug substances intended for hypersensitivity testing.
§ 310.200 - Prescription-exemption procedure.
§ 310.201 - Exemption for certain drugs limited by new-drug applications to prescription sale.
§ 310.303 - Continuation of long-term studies, records, and reports on certain drugs for which new drug applications have been approved.
§ 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
§ 310.306 - Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.
§ 310.501 - Patient package inserts for oral contraceptives.
§ 310.502 - Certain drugs accorded new drug status through rulemaking procedures.
§ 310.503 - Requirements regarding certain radioactive drugs.
§ 310.509 - Parenteral drug products in plastic containers.
§ 310.515 - Patient package inserts for estrogens.
§ 310.517 - Labeling for oral hypoglycemic drugs of the sulfonylurea class.
§ 310.518 - Drug products containing iron or iron salts.
§ 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.
§ 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.
§ 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.
§ 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.
§ 310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use.
§ 310.531 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.
§ 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.
§ 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products.
§ 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.
§ 310.536 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.
§ 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores.
§ 310.538 - Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.
§ 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.
§ 310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia.
§ 310.542 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.
§ 310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.
§ 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.
§ 310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
§ 310.546 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps.
§ 310.547 - Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.
§ 310.548 - Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease.

We have updated our Terms of Service, Privacy Policy, and Disclosures. By continuing to browse this site, you agree to our Terms of Service, Privacy Policy, and Disclosures.

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 insurance products 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 access to legal services through a network of provider 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 provider law firms.

You should not disclose confidential or potentially incriminating information to LegalFix—you should only communicate such information to your provider 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 insurance products, and access to the LegalFix network of provider law firms are subject to the LegalFix Terms of Service and Privacy Policy.

Bookish