21 CFR Subpart E Requirements for Specific New Drugs or Devices | Code of Federal Regulations | US Law | LawStack Online

21 CFR Subpart E

Requirements for Specific New Drugs or Devices

June 25, 2020

Patient package inserts for oral contraceptives

Certain drugs accorded new drug status through rulemaking procedures

Requirements regarding certain radioactive drugs

Parenteral drug products in plastic containers

Patient package inserts for estrogens

Labeling for oral hypoglycemic drugs of the sulfonylurea class

Drug products containing iron or iron salts

Drug products marketed as over-the-counter (OTC) daytime sedatives

Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention

Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac

Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents

Topically applied hormone-containing drug products for over-the-counter (OTC) human use

Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils

Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy

Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products

Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents

Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent

Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores

Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief

Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers

Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia

Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia

Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency

Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent

Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses

Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps

Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria

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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