Washington, D.C. – January 30, 2018 – The International Academy of Compounding Pharmacists (IACP) testified today before the U.S. House of Representatives’ Energy & Commerce’s Health Subcommittee Hearing on pharmacy compounding, “Examining Implementation of the Compounding Quality Act.”
IACP Vice President Shawn Hodges, PharmD, served as a witness representing 503A compounding pharmacies at today’s Congressional hearing. Dr. Hodges’ written testimony submitted to the Congressional Health Subcommittee can be viewed in its entirety here.
Dr. Hodges’ oral testimony focused on areas that the Food & Drug Administration (FDA) and stakeholders can work together towards compounding policies that better balance patient safety with patient access to critical medications.
IACP is an association representing more than 4,000 pharmacists, technicians, students, and members of the compounding community who focus upon the specialty practice of pharmacy compounding. Pharmacy compounding is the long-established tradition in pharmacy practice that enables physicians to prescribe and patients to take medicines that are specially prepared by pharmacists to meet patients’ individual needs.
Every day, compounding pharmacists serve patients in a variety of areas including: autism, oncology, dermatology and pediatrics, in a variety of practice settings including hospice in-patient units, emergency rooms, surgical centers, physician clinics, and even Federal Facilities like the VA. Compounding pharmacists also have served patients such as pre-term infants who require parenteral nutrition (PN). PN provides intravenous lifesaving therapy for patients whose gastrointestinal (GI) tracts are not functioning or cannot be accessed, or where nutritional needs cannot be met with oral or enteral diets. These are just a few examples of how compounding pharmacists are working with physicians to provide life-saving medications for patients.
While encouraged by some of the intended policy changes announced in the “2018 Compounding Policy Priorities Plan” released by the FDA, IACP is hopeful that this hearing will result in improved dialogue between the FDA and stakeholders, and that future FDA compounding policies will better reflect the input the Agency has received from prescribers and pharmacists. Our written testimony for this hearing of the Health Subcommittee is focused on the following policy areas:
- Office-use compounding pursuant to state pharmacy laws and regulations;
- The draft sample MOU between FDA and states on interstate distributions;
- Appropriate inspection standards for compounding pharmacies;
- Compounding with dietary supplements;
- Policymaking through Guidance for Industry instead of rulemaking;
- The Pharmacy Compounding Advisory Committee (PCAC).
IACP appreciates the opportunity to testify in today’s Congressional hearing on the many issues surrounding FDA’s implementation and enforcement of the DQSA. We strongly support HR2871 as a much-needed clarification and strengthening of the DQSA, and again urge the Congress to pass the bill this year. IACP stands ready to work with Congress to establish laws and regulation that protect patient safety, including access to critical compounded medications.
The International Academy of Compounding Pharmacists (IACP) is an association representing more than 4,000 pharmacists, technicians, students, and members of the compounding community who focus upon the specialty practice of pharmacy compounding. Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose healthcare needs cannot be met by manufactured medications. More than 150,000 patients and prescribers also belong to our organization via the grassroots advocacy group, Partnership for Personalized Prescriptions (P3). IACP’s mission of protecting, promoting and advancing personalized medication solutions is critical for patient healthcare. Visit www.iacprx.org to learn more and to find a compounding pharmacist.
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