Shipment Admissibility

FDA review process for imported human drugs

FDA reviews drug shipments at land and seaports, courier hubs and international mail facilities to determine whether they are admissible into the U.S. FDA uses a multi-layered, risk-based approach to identify violative imported drugs, combining data screening and physical examinations. The agency may refuse to let any human drug shipment enter the U.S. if the drugs appear to violate the Federal Food, Drug and Cosmetic Act.

An imported drug may be refused entry if, for example, it appears to be:

• Adulterated: Adulteration is defined under section 501 of the FD&C Act (21 U.S.C. 351). Generally, adulteration is defined as a violation of the FD&C Act which includes drugs that are defective, unsafe, not shown to be safe, filthy or produced under insanitary conditions. As a part of this, section 501(a)(2)((B) requires manufacturers to comply with current good manufacturing practice requirements as described at 21 CFR Parts 210 and 211.

Consequently, a drug may be adulterated if, for example, it was not manufactured in compliance with FDA’s rigorous quality requirements.

• Misbranded: Appropriate label information is an important aspect of marketing a drug because it gives patients the information they need to use the medication correctly. A drug label must therefore comply with FDA regulations. Section 502 of the FD&C Act generally describes misbranded drugs. A drug may be misbranded if, for example, its label is false or misleading or lacks FDA-required information.

A drug may be misbranded if a manufacturer has not complied with FDA requirements to register and list their drugs with the FDA. A drug also may be misbranded if it is a prescription drug offered for sale without a prescription.

• Unapproved: As described in section 505 of the FD&C Act, with certain limited exceptions, drugs must be proven to be safe and effective for use before companies can sell them in the U.S. A drug that lacks the required FDA-approval is an unapproved drug.

Additionally, to help ensure patient and consumer safety, FDA examines and analyzes samples of imported drugs to ensure they comply with applicable standards and/or label requirements.