Statement From IACP EVP/CEO David Miller, R.Ph. Regarding Congressman Markey's Bill
WASHINGTON, Nov. 8, 2012 /PRNewswire-USNewswire/ -- The International Academy of Compounding Pharmacists (IACP) has reviewed the legislation filed by Congressman Edward Markey in response to the meningitis outbreak that emanated from contaminated steroid injections prepared by New England Compounding Center, and we applaud the Congressman's efforts to ensure safety and advance quality in the compounding profession. The nation's compounders provide a vital service to patients in need and the Congressman's legislation recognizes and protects this service.
As with any piece of complex legislation, there are provisions that we support and those that we do not. Most notably, we support the preservation of state regulatory authority for traditional compounding pharmacy activities. All boards of pharmacy must be adequately funded by state legislatures in a manner sufficient to hire trained/educated pharmacists to conduct regular inspections of all pharmacies. Too many boards have been "de-funded" by the diversion of revenue from the Boards into the states' general funds, leaving administrative gaps.
Drug manufacturers are not compounders, and for that reason the IACP also supports ensuring that the FDA takes action against any business engaged in illegal drug manufacturing while still preserving the individual state's authority and right to govern the practice of compounding pharmacy.
The IACP also supports the following provisions:
- Allowing collaboration between the FDA and pharmacies to compound preparations to fulfill drug shortages or to protect public health.
- Providing for a process by which pharmacies may compound preparations to provide physicians, hospitals and clinical practice sites with medications necessary for administration to patients as part of their medical treatment.
- Ensuring that the FDA has clear authority to inspect any compounding pharmacy to assure that the storage and handling of medications are conducted in such a manner as to protect the health and safety of the public, although we would note that such authority already exists.
- The continuation of the FDA "Do Not Compound" list of drugs that have been determined by the FDA to be clinically unsafe. IACP believes this list must be created in collaboration with experts from the pharmacy and medical practice communities as the current FDA list was created without any review or input from practitioners.
While we support the concept of actively reporting adverse reactions to compounded preparations to the FDA's MedWatch program, the existing system is designed in such a manner as to actually impede pharmacists' participation. This will require more collaboration between the FDA and compounding pharmacists before it can be implemented.
Regarding a requirement that all compounded preparations be labeled as such, IACP has professional standards that specifically recommend such disclosure and encourages open communication with patients and prescribers about compounded medicines. Those labeling standards have been shared with Congress. IACP would only support mandating labeling to report serious adverse drug reactions for compounded preparations if identical wording is also required for all manufactured finished drug products as well as all medications compounded or dispensed by physicians, veterinarians or other health professionals.
We will continue to maintain an active role throughout the legislative process so that we can safeguard high quality and vitally important compounding services.
Contact: David Ball, Ball Consulting Group, LLC
On behalf of IACP
SOURCE International Academy of Compounding Pharmacists (IACP)