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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
 
PART 310NEW DRUGS
 

Subpart A--General Provisions
   § 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.

Subpart B--Specific Administrative Rulings and Decisions
   § 310.100 - New drug status opinions; statement of policy.
   § 310.103 - New drug substances intended for hypersensitivity testing.

Subpart C--New Drugs Exempted From Prescription-Dispensing Requirements
   § 310.200 - Prescription-exemption procedure.
   § 310.201 - Exemption for certain drugs limited by new-drug applications to prescription sale.

Subpart D--Records and Reports
   § 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.

Subpart E--Requirements for Specific New Drugs or Devices
   § 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.

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-l; 42 U.S.C. 216, 241, 242(a), 262.

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