NCPA Addresses Rep. Markey's Compounding Pharmacy Legislative Proposal
Alexandria, Va. - Nov. 1, 2012 Pharmacist and Senior Vice President for Government Affairs John Coster, RPh, PhD of the National Community Pharmacists Association (NCPA) issued the following statement regarding a legislative proposal announced today by U.S. Rep. Edward Markey (D-Mass.) that would impact patients and the pharmacists who provide them with access to essential medications through traditional compounding services:
"We appreciate and agree with Representative Markey's interest in wanting to achieve the proper balance to promote patient health and allow for traditional pharmacy compounding services to continue, while addressing any entities illicitly manufacturing pharmaceuticals under the guise of compounding, as highlighted by the tragic meningitis outbreak.
"Traditional pharmacy compounding is about the preparation of individual medications based on specific patient need and in response to a doctor's prescription. These services can, for example, help prevent an allergic reaction to a mass-produced drug, make medication palatable for children and alleviate drug shortages as evidenced by pharmacy's role during the H1N1 outbreak in 2009. By contrast, the New England Compounding Center (NECC) appears to have been engaged in inappropriately manufacturing medications and doing so without valid prescriptions.
"NCPA is reviewing this legislative proposal and we will formally provide our comments to the Representative's office as soon as possible. Based on our initial review, certain provisions in the bill likely would help address the anomalies like NECC. Those provisions represent a solution to an identified problem.
"However, the proposed legislation also appears to create new overly broad requirements on traditional pharmacy compounding that could negatively impact both patients' access to essential medications and the community pharmacists who provide them. As currently drafted, the legislation would grant new powers to an already stretched Food and Drug Administration to regulate traditional pharmacy compounding, and create new roadblocks for patients by requiring waivers for pharmacists to make medications that they have been making safely and effectively for decades.
"NCPA will continue to work constructively with Congress and other federal and state policymakers. Again, the focus must be on preserving patient access to vital traditional pharmacy compounding services while thwarting those who would illicitly manufacture large quantities of pharmaceuticals while purporting to be a compounding pharmacy."