Title 21

PART 310

Part 310 - New Drugs

PART 310 - NEW DRUGS 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.

21:5.0.1.1.2.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.2.1.1.1SECTION 310.3
   310.3 Definitions and interpretations.
21:5.0.1.1.2.1.1.2SECTION 310.4
   310.4 Biologics; products subject to license control.
21:5.0.1.1.2.1.1.3SECTION 310.6
   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.
21:5.0.1.1.2.2SUBPART B
Subpart B - Specific Administrative Rulings and Decisions
21:5.0.1.1.2.2.1.1SECTION 310.100
   310.100 New drug status opinions; statement of policy.
21:5.0.1.1.2.2.1.2SECTION 310.103
   310.103 New drug substances intended for hypersensitivity testing.
21:5.0.1.1.2.3SUBPART C
Subpart C - New Drugs Exempted From Prescription-Dispensing Requirements
21:5.0.1.1.2.3.1.1SECTION 310.200
   310.200 Prescription-exemption procedure.
21:5.0.1.1.2.3.1.2SECTION 310.201
   310.201 Exemption for certain drugs limited by new-drug applications to prescription sale.
21:5.0.1.1.2.4SUBPART D
Subpart D - Records and Reports
21:5.0.1.1.2.4.1.1SECTION 310.305
   310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
21:5.0.1.1.2.4.1.2SECTION 310.306
   310.306 Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.
21:5.0.1.1.2.5SUBPART E
Subpart E - Requirements for Specific New Drugs or Devices
21:5.0.1.1.2.5.1.1SECTION 310.501
   310.501 Patient package inserts for oral contraceptives.
21:5.0.1.1.2.5.1.2SECTION 310.502
   310.502 Certain drugs accorded new drug status through rulemaking procedures.
21:5.0.1.1.2.5.1.3SECTION 310.503
   310.503 Requirements regarding certain radioactive drugs.
21:5.0.1.1.2.5.1.4SECTION 310.509
   310.509 Parenteral drug products in plastic containers.
21:5.0.1.1.2.5.1.5SECTION 310.515
   310.515 Patient package inserts for estrogens.
21:5.0.1.1.2.5.1.6SECTION 310.517
   310.517 Labeling for oral hypoglycemic drugs of the sulfonylurea class.
21:5.0.1.1.2.5.1.7SECTION 310.518
   310.518 Drug products containing iron or iron salts.
21:5.0.1.1.2.5.1.8SECTION 310.519
   310.519 Drug products marketed as over-the-counter (OTC) daytime sedatives.
21:5.0.1.1.2.5.1.9SECTION 310.527
   310.527 Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.
21:5.0.1.1.2.5.1.10SECTION 310.528
   310.528 Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.
21:5.0.1.1.2.5.1.11SECTION 310.529
   310.529 Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.
21:5.0.1.1.2.5.1.12SECTION 310.530
   310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use.
21:5.0.1.1.2.5.1.13SECTION 310.531
   310.531 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.
21:5.0.1.1.2.5.1.14SECTION 310.532
   310.532 Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.
21:5.0.1.1.2.5.1.15SECTION 310.533
   310.533 Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products.
21:5.0.1.1.2.5.1.16SECTION 310.534
   310.534 Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.
21:5.0.1.1.2.5.1.17SECTION 310.536
   310.536 Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.
21:5.0.1.1.2.5.1.18SECTION 310.537
   310.537 Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores.
21:5.0.1.1.2.5.1.19SECTION 310.538
   310.538 Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.
21:5.0.1.1.2.5.1.20SECTION 310.540
   310.540 Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.
21:5.0.1.1.2.5.1.21SECTION 310.541
   310.541 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia.
21:5.0.1.1.2.5.1.22SECTION 310.542
   310.542 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.
21:5.0.1.1.2.5.1.23SECTION 310.543
   310.543 Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.
21:5.0.1.1.2.5.1.24SECTION 310.544
   310.544 Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.
21:5.0.1.1.2.5.1.25SECTION 310.545
   310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
21:5.0.1.1.2.5.1.26SECTION 310.546
   310.546 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps.
21:5.0.1.1.2.5.1.27SECTION 310.547
   310.547 Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.
21:5.0.1.1.2.5.1.28SECTION 310.548
   310.548 Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease.