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Electronic Code of Federal Regulations

e-CFR data is current as of June 1, 2020

Title 21Chapter ISubchapter DPart 310


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER D—DRUGS FOR HUMAN USE

PART 310—NEW DRUGS

rule

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.
rule

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.
rule

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.
rule

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.
rule

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.

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