In the wake of the New England Compounding Center tragedy, calls for greater controls over compounding pharmacies has spurred legislative activity in both the US Senate and the House of Representatives. State boards of pharmacy and the US Food and Drug Administration (FDA) have also increased regulatory scrutiny of these operations, resulting in the closure of additional compounding pharmacies in multiple states.1-3 Growing concern over the continued supply of quality products have many hospital pharmacies either evaluating “insourcing” sterile compounding operations or already actively engaged in these processes. By controlling the supply, production, and quality themselves, hospital pharmacists feel more assured of safer and consistent patient care surrounding the use of these compounded sterile preparations. Legislative Activity: Deciding Which Agency Has Oversight Nationally, the Senate’s Health, Education, Labor, and Pensions Committee (HELP) recommended that the FDA should be granted greater authority to regulate compounding pharmacies. The HELP Committee subsequently approved the Pharmaceutical Compounding Quality and Accountability Act (PCQAA).4
Under this proposed legislation 3 categories for sterile compounding would be created. The fi rst category would cover traditional compounding by pharmacies, wherein products are prepared pursuant to individual patient prescriptions. This category would include hospitals and hospital systems where anticipatory compounding occurs for products in advance of a prescription for use solely within the hospital system. This type of traditional pharmacy compounding would continue to be regulated by state boards of pharmacy. The second category clearly establishes that drug manufacturers would “continue tobe regulated by the FDA.” The third category presents a new approach to regulate large-scale drug compounders. The PCQAA terms these operations to be “compounding manufacturers” and defi nes them as businesses that produce “sterile compounded drugs in advance of a prescription and sells them across state lines.” Under the proposed Senate legislation, the door would be open for pharmacies to expand inhouse sterile compounding operations consistent with the requirements of the individual state boards of pharmacy.
Not surprisingly, the House of Representatives has adopted a different approach to this issue. The House Energy and Commerce Committee does not support giving the FDA more authority in this area, stating that it already has full authority to act to improve oversight and quality of compounded sterile products. To date, the House subcommittee seems more focused on continuing to analyze what went wrong with the New England Compounding situation and why the FDA did not respond more aggressively to previous quality and compliance issues that were documented for this compounding center.5 In view of this approach to the problem, hospital pharmacies would still be open to moving forward with expanding their internal sterile compounding operations.
United States Pharmacopeia Chapter 797
Detail of the procedures and requirements for compounding sterile preparations are delineated in the United States Pharmacopeia (USP) in Chapter <797> Pharmaceutical Compounding: Sterile Preparations. It also establishes standards that are applicable to all practice settings in which sterile preparations are compounded. USP <797> seeks to protect patients from harmful large content errors and microbial contamination of compounded sterile products.6 All of the USP chapters that fall below 1000 can be enforced by the FDA, adopted by state boards of pharmacy, and surveyed against by The Joint Commission. In fact, a 2011 survey found only 17 states directly referenced USP <797> in part or in its entirety as part of their individual state practice requirements.7 Many states are in various stages of retooling their regulations and how they will reference USP <797> as concern continues to escalate sterile compounding. It is also important to recognize that USP <797> is not a static document. The USP Sterile Products Expert Committee is continuously monitoring research and practice to suggest improvements to chapter <797> and revised chapters are periodically issued by the USP.
Pharmacies considering insourcing sterile products should be ready to adopt USP <797> as their minimum practice standard. This includes compliance with its recommended facility requirements, training, documentation, process control, and quality requirements.
One of the key elements for consideration by pharmacies is the risk level of the products that they will be compounding. USP <797> has established standards for low-, medium-, and high-risk compounding.