Qualifying Your Manufacturer: Is Your Product A Drug?
The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)]. 

Some manufacturers specialize in the manufacturing and distribution of "drugs" only, meaning they can only manufacture the types of products that meet the FDA definition of a "drug".

FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations.  The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.  The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

In the Federal Register of March 1999, the Food and Drug Administration published the OTC Drug Facts Label regulation. This regulation required most OTC drug products to comply with the new format and content requirements by May 2002. 

Patterned after the Nutrition Facts food label, the Drug Facts label uses simple language and an easy-to-read format to help people compare and select OTC medicines and follow dosage instructions. The following information must appear in this order:

  • The product's active ingredients, including the amount in each dosage unit.
  • The purpose of the product.
  • The uses (indications) for the product.
  • Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. This section also describes side effects that could occur and substances or activities to avoid.
  • Dosage instructions--when, how, and how often to take the product.
  • The product's inactive ingredients, important information to help consumers avoid ingredients that may cause an allergic reaction.
Along with the standardized format, the label uses plain-speaking terms to describe the facts about each OTC drug. The label also requires a type size large enough to be easily read and specific layout details--bullets, spacing between lines, and clearly marked sections--to improve readability.

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