Compounding issues

APC POLICY STATEMENT:
Compounded Bio-Identical Hormone Therapy

Highlights

  • APC opposes any additional regulation of cBHT.
  • APC supports all compounded hormone therapy, with no preference for particular dosage forms.
  • APC opposes restrictions that would limit hormone-therapy compounding to 503B pharmacies.

Official policy of the alliance

The Alliance for Pharmacy Compounding supports without additional restriction the ability of pharmacists to compound hormones as prescribed to treat the individual needs of patients who are under the care of a physician.

APC finds the FDA-funded cBHT study prepared by the National Academies of Science, Engineering, and Medicine to be poorly designed, poorly informed, and missing significant data from prescribers of cBHT. APC will oppose aggressively efforts to restrict cBHT based on the recommendations of this deeply flawed study.

APC will oppose additional regulation or other action that would arbitrarily restrict patient access to or preference particular dosage forms of cBHT. Moreover, APC will oppose regulation to require that compounders of cBHT adhere to current Good Manufacturing Practices or that would preference hormone compounding by 503B outsourcing facilities over 503A compounding pharmacies or vice versa.

APC is open to dialogue with regulators about reasonable enhancements to the labeling of compounded hormones, with the understanding that the range of dosage forms and formulations make complete standardization of labeling practically impossible. Likewise, APC is open to dialogue with regulators about reasonable enhancements to adverse events reporting related to compounded hormones.

Oversight and implementation of this policy statement is given to APC’s Federal Legislative Committee, in coordination with APC’s chief executive officer and contracted governmental affairs counsel. Any proposed deviation from this policy statement must be approved by the Board of Directors.

Approved and adopted December 9, 2020.