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Congress urged to keep oversight of compounding to state pharmacy boards
July 17th, 2013
WASHINGTON – The National Association of Chain Drug Stores and the National Community Pharmacists Association provided insight to a congressional committee examining ways to tighten regulation of pharmacy compounding.
NACDS said it submitted a statement to the House Committee on Energy and Commerce Subcommittee on Health for its Tuesday hearing titled "Reforming the Drug Compounding Regulatory Framework."
Besides commending the subcommittee for its thorough evaluation of the pharmacy compounding issue, NACDS stressed the need for collaboration betwee state and federal agencies.
"NACDS supports the mission and work of 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,” the association said in its statement.
State boards of pharmacy should retain sole jurisdiction over traditional prescription drug compounding, and the Food and Drug Administration should regulate the manufacturing of prescription drugs, NACDS noted.
The association also pointed to the need for the FDA and state pharmacy regulators to work together to flag rogue entities that aim to use a state pharmacy license to avert 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 comments to the subcommittee.
NACDS also cited the importance of protecting pharmacists' ability to provide 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," the association explained.
Providing testimony at the hearing was NCPA chief executive officer B. Douglas Hoey, whose remarks focused on draft legislation offered by Rep. Morgan Griffith (R., Va.) that aims to address the concerns raised by the New England Compounding Center's (NECC) fungal meningitis tragedy late last year.
"NCPA supports the approach of Rep. Griffith's discussion draft, as it is not a broad expansion of FDA power over historically state-regulated pharmaceutical compounding but, to the contrary, strikes a proper balance of making certain that future tragedies are avoided while also preserving patients' access to vital compounds," Hoey explained.
"Rep. Griffith's discussion draft recognizes that pharmacist compounding is an integral part of the pharmacy profession and meets patients' needs in a variety of care settings," he noted. "When manufactured drugs aren't an option, independent community pharmacists prepare customized medications for patients in accordance with a prescriber's prescription based on the patient's individual needs."
NCPA said its supports provisions in the discussion draft for preserving state board of pharmacy oversight of compounding; maintaining anticipatory compounding and office use in instances where state law allows; and recognizing the need to bolster the lines of communication between the state pharmacy boards and the FDA.
In addition, NCPA expressed concerns about three legislative proposals that would grant the FDA unrestricted authority over a "do not compound" list, which could impact patient access to compounded drugs such as hormone medications, thyroid preparations, promethazine gels, and medications to treat autism; require burdensome notification requirements from pharmacies to the FDA when compounding medications are in short supply; and exempt pharmacies within health systems from compounding standards.
"Throughout Congress' efforts to determine the best course of action for preventing another NECC tragedy from occurring, NCPA has been a constructive force to find the best solution," added Hoey. "We believe patient access to compounded medications must be preserved and that Rep. Griffith's proposal is the best approach going forward."