This page is editorial explanation, not legal advice. The FDA Personal Importation Policy is a stated enforcement posture, not a statute that grants any right. Consult qualified counsel before any importation. Nothing here authorises any action.
What enforcement discretion means
The Federal Food, Drug, and Cosmetic Act prohibits the import of unapproved drugs into the United States. The FDA, the agency tasked with enforcing the Act, has stated in published policy guidance that it generally does not prioritise enforcement against individual consumers importing small quantities of a non-controlled medication for personal use under defined conditions.
The operative word is discretion. The underlying law has not changed. The agency has stated where it chooses to look and where it does not. A discretion posture can be revised at any time. Customs and Border Protection makes independent decisions about parcel entry.
The 90-day supply guideline
The FDA Regulatory Procedures Manual, Chapter 9, includes a guideline that personal importation of non-controlled prescription medication may, at agency discretion, be permitted if the quantity is limited to a 90-day supply, the product is for personal use, the user identifies in writing the prescriber and treatment, and the medication is not for a serious condition for which effective US treatment exists.
These are guideline criteria, not statutory rights. Meeting them does not guarantee parcel entry. Not meeting them does not guarantee seizure.
What is and is not allowed
- Non-controlled prescription medication
- Personal use, 90 day supply or less
- Written prescriber identification
- Product matches a US-approved equivalent
- Controlled substances of any schedule
- Commercial quantities or resale intent
- Products with no US-approved equivalent for serious conditions
- Cold-chain biologics outside compliant logistics
Comparable policy notes
For context, four other jurisdictions have written guidelines that address personal importation. None are identical to the US posture.
MHRA permits personal import of up to a three-month supply of non-controlled prescription medication, with a written prescription, for personal use.
Health Canada generally allows personal importation of up to 90 days of non-controlled medication carried in person or shipped to self, with prescription evidence.
Swissmedic permits personal import of approximately one month supply for personal use, with stricter treatment for narcotics and biologics.
MoHAP permits personal import of three-month supply with prescription, plus an online declaration for select restricted categories.
This is editorial explanation, not legal advice. Consult counsel before any importation. Nothing on this page authorises any importation, encourages any importation, or interprets the legality of any specific transaction.
- FDA Regulatory Procedures Manual, Chapter 9 . Coverage of personal importation
- FDA . Personal Importation policy page on fda.gov
- CBP . parcel inspection authority
- MHRA UK . personal import of medicines guidance
- Health Canada . importing health products for personal use