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Press Release

ASHP Calls for State Oversight of Pharmacist Sterile Compounding

State boards of pharmacy should have responsibility for enforcing application of quality assurance standards for sterile compounding and should not be limited to one particular set of standards as they apply their oversight, American Society of Health-System Pharmacists Executive Vice President and Chief Executive Officer Henri R. Manasse, Jr. Ph.D., Sc.D., told members of the Food and Drug Administration's (FDA) Pharmacy Compounding Advisory Committee today. Manasse represented the Society at a public meeting to discuss FDA's plans to implement the pharmacist compounding provisions of the Food and Drug Administration Modernization Act.

Provisions in the 1997 law require the FDA to develop a list of drug products that are "demonstrably difficult" to compound. Late last month, the agency released a concept paper articulating its preliminary thinking about which products to include on this list. One of the categories mentioned in the concept paper is sterile products compounded under procedures other than those described in Chapter 1206 of the United States Pharmacopeia. 

ASHP objected to FDA's sole reliance on the standards outlined in Chapter 1206 and recommended that the agency encourage boards of pharmacy to also base their oversight of sterile product compounding on the Society's "Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products," as well as new scientific knowledge. "This will foster the establishment of a national quality assurance standard for compounding sterile products in all pharmacy settings," Manasse said. "The use of both the USP Chapter and ASHP's guidelines, as well as the latest scientific knowledge in the literature, would provide the assurance the FDA is seeking for the safety and effectiveness of these products." 

This issue is particularly important to ASHP members because of their extensive involvement in inpatient i.v. admixture services, home infusion services, and various other specialized services in which pharmacists customize medicine dosages to the specific needs of patients. The Society has a long history of developing applicable practice standards and has published numerous articles on the topic in the American Journal of Health-System Pharmacy. 

The complete text of Manasse's comments is available online. ASHP will submit detailed written comments on the concept paper to FDA before the August 15 deadline. The FDA will use the feedback it receives to develop proposed regulations. 

ASHP is the 30,000-member national professional association that represents pharmacists who practice in hospitals, health maintenance organizations, long-term care facilities, home care, and other components of health care systems. ASHP, which has a long and distinguished history of medication error prevention efforts, believes that the mission of pharmacists is to help people make the best use of medicines. Assisting pharmacists in fulfilling this mission is ASHP's primary objective. The Society has extensive publishing and educational programs designed to help members improve their delivery of pharmaceutical care, and it is the national accrediting organization for pharmacy residency and pharmacy technician training programs.