NACDS Emphasizes Importance of Distinguishing Between Prescription Drug Compounding and Manufacturing

PRESS RELEASE

July 16, 2013 (Arlington, Va.) — The National Association of Chain Drug Stores (NACDS) submitted a statement to the U.S. House of Representatives Committee on Energy and Commerce Subcommittee on Health leading up to their hearing today titled, “Reforming the Drug Compounding Regulatory Framework.” NACDS’ statement commended the subcommittee for its thorough evaluation of the prescription drug compounding issue and emphasized the importance of ensuring patient health through collaboration of state and federal agencies.

“NACDS supports the mission and work of [Food and Drug Administration] FDA in ensuring that Americans receive only safe and effective prescription drugs. Safeguarding the health and welfare of our patients remains our highest priority. Pharmacist compounding services are the only source of critical medications for millions of patients who each have their own unique health care needs,” NACDS said in its statement.

NACDS emphasized that the state boards of pharmacy should retain sole jurisdiction over traditional prescription drug compounding, and FDA should regulate the manufacturing of prescription drugs. The association cited the need for collaboration between FDA and state pharmacy regulators to root out rogue entities that seek to use a state pharmacy license as a shield from federal oversight.

“To this end, we support legislative initiatives to establish a reporting tool for state boards of pharmacy to identify compounding pharmacies that may be in violation of accepted compounding practices and/or are operating as a manufacturer,” NACDS said in its statement.

NACDS also cited the importance of protecting pharmacists’ ability to provide traditional prescription drug compounding services as needed for patients.

“Prescription drug compounding practices enable pharmacists to meet the medication needs of their patients that cannot be met with commercially available products, and compounding of commercially available products that are in shortage as identified on a public or private national or regional shortage list,” NACDS said in its statement.