2003 CFR Title 21, Volume 5

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES 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.
	310.501	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.