The AAHP established a homeopathic Drug Listing SPL Sub-Team to work with FDA’s Electronic Drug Listing group to address some of the unique challenges faced by homeopathic drug companies in complying with the requirements for electronic registrations.
The primary objective of the team is to improve AAHP member compliance to the regulatory requirement for electronic establishment registrations and drug listings. Based on the previous AAHP member survey on electronic drug listing and the initial Homeopathic Sub-Team meetings, the initial primary objective pertained to addressing the labor intensiveness of the electronic drug listing process and the inefficiency associated with identifying one “strength” per listing.
Solution Agreed Upon April 2011 Homeopathic Sub-Team Meeting:
Lonnie Smith (FDA Policy Analyst) indicated that homeopathic drug companies submitting drug listings will not be required to submit one SPL file (or one listing) per potency. He indicated that a company can just submit the “largest potency” (e.g. the potency closest to the original mother tincture) for each active ingredient rather than submitting every potency marketed for each active ingredient. Mr. Smith indicated that a firm could either submit a label that identified the range of potencies marketed or submit multiple labels (in the same SPL submission) that show all potencies of the active being marketed. Mr. Smith also indicated that firms could immediately begin executing their drug listings in the manner identified above.