Can I import prescription drugs into the U.S. to sell?

Generally no. Commercial importation of unapproved drugs — including foreign-market versions of U.S.-approved drugs — is prohibited under the FDCA. A drug must be FDA-approved, made in a registered facility, and listed before it can be imported for the U.S. market.

Is it legal to buy my medication from a foreign pharmacy?

It is not automatically legal. The FDA’s Personal Importation Policy is discretionary enforcement, not authorization, and the agency applies it case-by-case to small personal quantities of drugs for serious conditions with no U.S. alternative. The FDA can refuse any noncompliant shipment.

What extra rules apply to controlled substances?

The importer needs a DEA registration and, for many schedules, an import permit on DEA Form 357 (or a Form 236 declaration) filed before entry, in addition to all FDA requirements.

Who is responsible if an imported drug shipment is noncompliant?

The importer of record, under the duty of reasonable care — even when a broker files the entry. The FDA can detain or refuse the goods, and DEA or civil penalties may follow for controlled-substance violations. Drug importation is a default-prohibited area where the authorizations, not the goods, do the work. Reidel Law Firm helps importers confirm FDA and DEA requirements before they commit, on flat-fee terms with a plain-English compliance memo and direct attorney access. Get an import compliance memo.

How to Import Pharmaceuticals: FDA and DEA Rules

Importing pharmaceuticals into the United States is tightly restricted: a drug generally must be FDA-approved, made in a registered facility, and listed with the FDA before it can lawfully enter, and commercial importation of unapproved or foreign-market versions of a drug is prohibited under the Federal Food, Drug, and Cosmetic Act (FDCA). This is the opposite of most consumer imports — for drugs, the default rule is “no” unless a specific authorization applies. This guide explains