In the US, Pharmaceutical Products are regulated by the US Food and Drug Administrion ( FDA ) through The Federal Food, Drug, and Cosmetic Act . With numerous amendments it is the most extensive law of its kind in the world. The Federal Food, Drug, and Cosmetic Act defines a "drug" as:

(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and
(D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) of this title or sections 403(r)(1)(B) and 403(r)(5)(D) of this title, is made in accordance with the requirements of section 403(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

The FDA regulates pharmaceuticals through it's Center for Drug Evaluation and Research (CDER). The Center has oversight responsibilities for prescription, over-the-counter and generic drugs. This responsibility includes products that many consumers usually do not associate as drugs, such as fluoride toothpaste, dandruff shampoos and sunscreens. CDER carefully evaluates the benefits and risks of drugs and ensures that consumers have access, as quickly as possible, to promising new treatments. The Center oversees the research, development, manufacture and marketing of drugs. CDER ensures truth in advertising for prescription drugs and monitors the use of marketed drugs for unexpected health risks. If unexpected risks are detected after approval, CDER takes action to inform the public, change a drug's label, or--if necessary--remove a product from the market. Specifically, CDER regulates:

Prescription Drugs
Prescription medicines include any drug product that requires a doctor's authorization to purchase.

Generic Drugs
A generic drug is a drug product that is equivalent to brand name products in terms of quality and performance.

Over-the-Counter Drugs
OTC drug products are available to consumers without a doctor's prescription.

Under current law, all new drugs need proof that they are effective and safe before they can be approved for marketing. Prior to approval, the firm may attend Advisory Meetings with the FDA and conduct Clinical Trials. Drug Submissions required for approval may include New Drug Approvals (NDA) and Abbreviated New Drug Approvals (ANDA).

In addition, Section 510 of the Federal Food, Drug, and Cosmetic Act requires manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products to register their establishment(s) and submit a listing of every product in commercial distribution with the FDA. These are done through Form FDA 2656 - Registration of Drug Establishment/Labeler Code Assignment, Form FDA 2657 – Drug Product Listing, and Form FDA 2658 – Registered Establishment’s Report of Private Label Distributors

Once approved, firm is required to follow 21 CFR Parts 210-211.

Pharmaceuticals, Biologicals, Combination Products, Medical Devices, Cosmetics, Animal Drug, Clinical Trial, Food & Dietary Supplements

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