Homeopathic Drug Registration & Listing

SPL Electronic SubmissionAnnual RenewalNDC RequiredSince 2009

About Homeopathic Drug Registration

FDA defines a Homeopathic Drug as any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.

All domestic firms that manufacture, prepare, propagate, compound, or process homeopathic drugs must register with FDA as a drug establishment and list homeopathic drug products with US FDA. All foreign firms who import homeopathic drugs or offer them for import into the US must register their establishment and list drug products with FDA.

Drugs that are not properly listed as required are considered to be misbranded and may be subject to regulatory action. Homeopathic drug registration information must be renewed annually. Any additional updates to drug listing information must be submitted in June and December of each year.

Electronic submission of homeopathic drug listing should be done by creating an SPL (Structured Product Labeling). FDA no longer accepts submission in paper format unless a waiver is granted.

Liberty Management Group Ltd provides assistance in homeopathic drug establishment registration, homeopathic drug listing, and SPL preparation and submission to FDA ESG.

Because no homeopathic drug products have been determined by the FDA to be generally recognized as safe and effective (GRASE), the FDA applies a risk-based enforcement strategy to unapproved homeopathic drugs. As a result, any homeopathic drug product marketed illegally is subject to FDA enforcement action at any time.

Frequently Asked Questions

Common questions about FDA homeopathic drug regulations.

Who must register homeopathic drugs with FDA?

All domestic and foreign firms that manufacture, prepare, compound, or process homeopathic drugs listed in the HPUS must register with FDA as a drug establishment and list all products.

Does homeopathic drug registration need to be renewed?

Yes. Homeopathic drug registration information must be renewed annually between October 1 and December 31. Drug listing updates must be submitted in June and December.

Is paper submission accepted for homeopathic drug listing?

No. FDA no longer accepts submissions in paper format. Electronic submission via SPL (Structured Product Labeling) through FDA ESG is required unless a waiver is granted.

What is the consequence of not listing homeopathic drugs?

Drugs that are not properly listed as required are considered misbranded and may be subject to regulatory action, including import holds and warning letters.