The International Academy of Compounding Pharmacists (IACP) recently recommended changes in state pharmacy practice acts to ensure that states have set in regulation the highest standards—United States Pharmacopeia (USP) <795> and USP <797>—and to eliminate the gray area and loopholes that can be exploited by a compounder seeking to manufacture without a license, according to IACP spokesperson David Ball.
IACP formally announced the state-level recommendations during a national town hall–style teleconference for IACP members, state pharmacy associations, and state boards of pharmacy on December 7. USP <797> is a national standard for any compounded sterile preparations, and USP <795> provides similar guidance for nonsterile preparations compounded in health care settings, according to the FAQs posted on the Just the Facts: Compounding section of pharmacist.com.
The IACP action came in the wake of the fungal meningitis outbreak linked to the New England Compounding Center (NECC) facility that has resulted in 37 deaths and 590 illnesses in 19 states as of December 10, according to CDC. In November 15 testimony before a Senate committee, IACP Executive Vice President and CEO David G. Miller, BSPharm, had indicated that NECC was not a compounding pharmacy but rather was acting as an illegal drug manufacturer.
Developed by the IACP Board of Directors, the principles of the recommendations “focus on assuring inspection authority by and adequate funding of all state Boards of Pharmacy, individual practices' compliance with state laws and regulations, and mandatory compliance with quality standards for all practitioners engaged in compounding,” according to a statement on the IACP website.
The practice of pharmacy, and therefore compounding, is regulated at the state level, Rebecca P. Snead, BSPharm, Executive Vice President & CEO, National Alliance of State Pharmacy Associations (NASPA), told pharmacist.com. “It is critical that state regulators are proactive in their review of their rules and regulations to ensure they have addressed any areas that may be improved,” Snead said. “In addition, they must remain diligent in their enforcement of their regulations.
Asked if IACP planned to release federal recommendations related to FDA activity and Congress, Ball told pharmacist.com, “We continue to work closely with Congress and the FDA to ensure that federal law and regulations ensure the safest possible environment for compounding.”
Ball added that feedback from state associations, state boards, and IACP members during the teleconference was “supportive.”
Noting that NASPA had just received the IACP state recommendations, Snead said, “They seem reasonable; however, we have not yet discussed them with the states.”