Compounded Medications

The Challenge: Since enactment of the Drug Quality and Security Act (DQSA) in late 2013, the US Food and Drug Administration (FDA) has gone significantly beyond the letter of the law in developing regulations that would limit access to safely compounded medications and their availability for office use – particularly through the traditional (503A) channels that doctors and patients have come to rely on. FDA officials are convinced that compounded medications bring only a marginal benefit to health compared with FDA-approved drugs.  Patients, naturopathic doctors, and other healthcare practitioners know better. 

AANP Actions: Over the past 3 years, AANP and many other organizations (compounders, integrative and conventional health care practitioners, patient advocacy groups) have submitted numerous comments to the Agency, presented in-person stakeholder comments, participated in meetings of the FDA’s Pharmacy Compounding Advisory Committee, and convinced Members of Congress to direct FDA concerning the intent of the DQSA. None of these actions has deterred the Agency from its regulatory path. The latest example: in December 2016 the FDA proposed its final office use rules, which are unaltered from an earlier proposed version.

Strategic Need: In addition to continued legislative efforts, it is appropriate now to file an administrative petition with the FDA. This petition will challenge the FDA’s process, its decision making, and its manifestly ‘stacked deck’ against compounding. An expert attorney has been retained to draft the petition, with input from other attorneys active in the DQSA Coalition, an organization formed by the International Academy of Compounding Pharmacists that involves some three dozen national groups. 

The value of such a petition is three-fold:

  • It will present objections and concerns to a full and cohesive way, which has not been done in one filing before.  Instead, each organization has presented its case separately.
  • It will push the FDA toward a final rulemaking on issues where the agency has primarily published “interim final rules” or “compliance policy guidances.”
  • It will help position our organizations to file a lawsuit if the agency’s response is inadequate.
Funds Sought: An initial $40,000 will be needed to support the filing of this Administrative Petition.  Depending on how the action plays out, additional resources may be needed to file an appeal in Federal court.  If this effort is to succeed, the naturopathic community needs to be on board.  AANP asks state associations, individual naturopathic doctors, and grateful patients to support the petition with a meaningful financial contribution.  AANP has created this campaign page – “Save Compounded Medications, Save Lives, Help Patients – to make it easy to donate. 

Donation Challenge: The New Hampshire Association of Naturopathic Doctors is ready to donate $1,000 to our campaign as soon as other state associations match the challenge.  AANP encourages the larger state associations – those with many more members who treat many more patients – to contribute up to $5,000.  At stake is nothing less than the continued availability of safely compounded medications, including via office use.

AHPA 2017 White Paper: Good Herbal Compounding and Dispensing Practices

H.R 2871: Preserving Patient Access to Compounded Medications Fact Sheet 

Bulk Drug Substances Under FDA Evaluation