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FDA Web Page on Drugs
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FDA Web Page on Vaccines, Blood & Biologics

Drugs and Biologics

 

drug includes:
  • 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;
  • articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;
  • articles (other than food) intended to affect the structure or any function of the body of man or other animals; and
  • articles intended for use as a component of any articles specified above.

There are certain exemptions for food and dietary supplements.

The FDA Center for Biologics Evaluation and Research (CBER) regulates vaccines, blood, and biologics.  This category includes a variety of products including blood bank devices, cellular and gene therapy products, allergenics, and others. The FDA Center for Drug Evaluation and Research (CDER) is the main entity within FDA that implements drug regulations.

Reporting to the FDA is required for:

  • discontinuation of all marketing of a drug previously listed;
  • marketing of a new drug not reported previously;
  • revised labeling for a previously listed product.
  • the start of marketing of a drug previously discontinued;
  • modifications or additions to the information concerning a drug previously listed; and

New human or veterinary drugs (i.e., those with new intended uses or new chemical entities) need to be approved by the FDA for safety and effectiveness, and their labeling reviewed for accuracy and thoroughness.

Facilities that manufacture, repack, prepare, propagate, compound, or process a human or veterinary drug or human biological product are required to register with FDA and list every drug is in commercial distribution. FDA requires strict Current Good Manufacturing Processes (CGMPs) for drug products. Companies are required to report to FDA all serious, unexpected adverse drug experiences associated with the use of the drug product manufactured, packed, or distributed by the company.

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.