Heparin is regulated by FDA as a drug; foreign manufacturers must be registered and comply with USP monograph specifications and current GMP standards. Following past adulteration events, FDA has heightened scrutiny of heparin supply chains, and importers should ensure robust supplier qualification, including independent pharmacopeial testing for identity and purity before entry.

USDA APHIS may assert jurisdiction over animal-derived biological materials depending on their origin species and intended use, particularly for products that could serve as vectors for animal disease. Importers should consult both FDA and APHIS requirements before shipping, as dual-agency review is possible for certain animal-origin therapeutic substances.