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FDA Drug Requirements

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FDA Drug Requirements

FDA defines drugs as one of the following:

  • A substance recognized by an official pharmacopoeia or formulary
  • A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
  • A substance (other than food) intended to affect the structure or any function of the body.
  • A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.

Most drugs must be approved by FDA under a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) or be generally recognized as safe and effective (GRASE) by qualified experts.

In addition to the above, the following requirements must be met to market a drug in the US:

Establishment Registration

Any establishment that manufactures, repacks, relabels, or salvages a drug for distribution in the US must be registered with FDA as a drug establishment. Companies that only import drugs (do not perform any of the above activities) do not need to register with FDA.

Drug Listing

A registered drug establishment must list with FDA, each drug it distributes in the US. Each listed drug is assigned a National Drug Code (NDC). For importing a drug, the Customs filer/broker must submit the NDC number when filing the entry.

Good Manufacturing Practices (GMPs)

Drugs must be manufactured and packed under FDA’s Good Manufacturing Practices (GMPs). The GMPs cover the design, monitoring, and control of the manufacturing facility and manufacturing processes to ensure the products meet requirements for the identity, strength, quality, and purity of the drugs.

Over-The-Counter (OTC) Drugs

OTC drugs (not Including OTC homeopathic drugs) must comply with an FDA drug monograph which contains requirements for the drug’s ingredients, uses (indications), doses, formulations, labeling, and testing requirements. Most of the monographs can be found in section 300 of the US Code of Federal Regulations and are also published in the US Federal Register. 

OTC Homeopathic Drugs

OTC homeopathic drugs must be intended for self-limiting, self-diagnosable conditions, and their active ingredients must be recognized by an industry or FDA-recognized homeopathic compendia such as the Homeopathic Pharmacopeia, Materia Medica, etc. The ingredients must be within concentration limits set by the applicable ingredient monograph. Homeopathic drugs are exempt from FDA’s new drug approval requirements.

Labeling Compliance

The labels of OTC drugs must comply with all of FDA’s drug label requirements such as having a properly declared statement of identity, net quantity of contents, name and place of business (manufacturer, packer, or distributor), expiration date, and a Drug Facts panel which states the active ingredient, uses, warnings, inactive ingredients, purpose, directions, and contact information.

Investigational New Drugs

A drug that will only be used in a clinical study (will not be used for commercial purposes) may be distributed or imported under an FDA-approved Investigational New Drug (IND) application. FDA assigns the drug an IND number. To import an IND, the Customs filer/broker must declare the IND number to FDA when filing the entry.

California Proposition 65

For products marketed in California (including packaging), Proposition 65 requires businesses to provide warnings to the consumers about any substances in the products that California believes causes cancer or reproductive harm including birth defects. California lists these substances in its “Prop 65 list” ( https://oehha.ca.gov/proposition-65/proposition-65-list). If the products contain any of those listed substances, companies can usually meet the Prop 65 requirements by placing the appropriate warning statement on the product’s label.

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Richard Chiang worked for the FDA for 13 years beginning as a field investigator and entry reviewer and later worked at the FDA’s headquarters Center for Food Safety and Applied Nutrition (CFSAN)

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