AboutMichael Anisfeld Expertise Disclaimer:
SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT).
My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements
Experience
Past/Present Clients UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
Question What license is required to manufacture prescription drugs in the US for export only to the EU?
Answer It makes no difference whether the drug manufactured in the USA is for domestic sale only, or for export only, or for a combination. All drugs manufactured in the USA need to be registered and approved by FDA (using either the NDA or ANDA registration route), and the manufacturing operations will be inspected for compliance with Good Manufacturing Practices.
Incidentally a few years ago I tried to get around this by manufacturing drugs in an "Foreign Export Zone", but was told by attorneys that an FEZ is only a customs tariff issue, and I would still need to meet all other laws of the US including safety, health, and all FDA regulations.
