Prior to this, the professional activities in health care were subject to only state regulation rather than federal. This amendment was created in response to a contaminated sterile preparations originating in Massachusetts, to take action against this practice. With the authority of the DQSA, the FDA is enabled to create regulations in accordance with the provisions of the law.
Concerned about some of the processes that are both being created and being enforced legislative relief is being sought by the International Association of Compounding Pharmacists and other pharmacy organizations. The Integrative Medicine Consortium (IMC), comprised of practitioners have recognized concerns in the processes instituted to allow or disallow active ingredients, and approval processes that have difficulty addressing the needs of individual patients and clinical practice. Valuable active ingredients are in danger of becoming illegal to use. In response, the IMC has taken the first step to challenge the FDA by filing a Citizen’s Petition.
Compounding pharmacies have been partnering with A4M to help achieve the goals of this organization. Many active ingredients need to be dose adjusted, dosage forms changed, combined for convenience and additives removed. This includes ingredients such as nutrients, bioidentical hormones, peptides and botanicals.
The Citizen’s Petition can be viewed at: www.naturopathic.org/compoundedmeds
Background information has been prepared and posted by the American Association of Naturopathic Physicians (AANP) to make it easy to understand and follow up with your invaluable comments. Support is also requested to help fund this legal challenge.
