NCPA and the Alliance for Pharmacy Compounding submitted joint comments urging the Food and Drug Administration to take steps that would allow greater access to testosterone for menopausal women.
Among other things, we recommended that the FDA:
1. Recognize the role of 503A compounding pharmacies to compound testosterone products for those whose needs cannot be met by commercially available products, including situations involving individualized dosing, alternative routes of administration, or tolerability concerns;
2. Clearly distinguish in its communications between unlawfully marketed unapproved drug products and medications lawfully compounded by 503A pharmacies; and
3. Work with the Drug Enforcement Administration to reassess testosterone’s classification as a Schedule III controlled substance, including its effect on women’s therapy.
