When is a Homeopathic Product OTC or Rx ?

by Eric L. Foxman, R.Ph.

Homeopathic drug products must meet stringent criteria for labeling and marketing. The specific criteria for Over-the-Counter (OTC) and Prescription drugs are enumerated in the FDA Compliance Policy Guide[1]. How those criteria are understood is dependent on whether the active components are listed in the Homeopathic Pharmacopeia of the United States (HPUS).

If the OTC criteria cannot be met, the homeopathic drug product must be distributed as a prescription only (Rx) drug; the labeling must include the Federal Legend, different labeling requirements must be met, and a host of control mechanisms must be instituted. The following is the AAHP’s understanding of the applicable regulations:

1. If the active homeopathic ingredient(s) is monographed in the HPUS, the drug may be labeled and distributed as an OTC product when;
   • the homeopathic ingredient(s) is manufactured in accordance with the HPUS,
   • the homeopathic ingredient(s) is used at or above the HPUS listed OTC attenuation, and
   • the label indication(s)/claim(s) satisfy the OTC criteria as stated in the FDA Compliance Policy Guide [CPG 7132.15]: the product is “intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment”.
2. If the active homeopathic ingredient(s) is not monographed in the HPUS, the drug may be labeled and distributed as an OTC product when;
   • the homeopathic ingredient(s) is manufactured in a homeopathic manner
   • the homeopathic use of the homeopathic ingredient(s) can be justified by the manufacturer to the satisfaction of the FDA.[2],
   • the safety of the homeopathic ingredient(s) in the attenuation(s) used can be justified by the manufacturer, and
   • the label indication(s)/claim(s) satisfy the OTC criteria as stated in the FDA Compliance Policy Guide [CPG 7132.15]: the product is “intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment.”
3. If the criteria in 1) or 2) above cannot be met, the Homeopathic drug product must be labeled and distributed as prescription only homeopathic drug and the labeling must bear the Federal Legend.

The AAHP supports compliance by all manufacturers. Members are reminded that the member renewal pledge binds us to “supporting the manufacture, distribution, marketing and sales of homeopathic drug products according to all applicable regulations” and the AAHP Mission Statement pledges the association and its members to “supporting the requirements, criteria, and published guidelines in the HPRS, CPG, and other applicable regulations”.