Pharmacy compounding of high-risk level products and patient safety

Abstract

Until the regulatory debate is resolved, pharmacists engaged in pharmacy compounding, particularly in the preparation of high-risk level CSPs, should remain competent in their skills and practice in accordance with federal, state, and USP chapter 797 requirements and, thereby, protect patients and the professionalism of pharmacy.

Pharmaceutical compounding: Recent advances, lessons learned and future perspectives

“…There are several publications in the literature regarding the potential risks of Pharmacy Compounding and compounded medicines are characterized as highrisk level products for patient safety, especially for compounded sterile preparations [1][2][3]. Mullarkey (2009) described in her publication several issues surrounding pharmacy compounding, such as activities of compounding pharmacists, quality of compounded sterile preparations especially compounding errors (including purposeful potency alterations, unreported contamination etc.)…”

“…Mullarkey (2009) described in her publication several issues surrounding pharmacy compounding, such as activities of compounding pharmacists, quality of compounded sterile preparations especially compounding errors (including purposeful potency alterations, unreported contamination etc.) and therapy issues [1]. There are several risks and liabilities of prescribing compounded medications (i.e.…”

Community pharmacy compounding–impact on professional status

“…The role of compounder of medicines was the basis of pharmacy's claim to professional status as a unique area of knowledge recognised and valued by society [19,21,[26][27][28][29]. Until the early 20th century, the traditional role of the pharmacist to procure, store, compound and dispense specific medicines and pharmaceutical products was indispensible to physicians and patients and has been described as resulting in ''a close relationship between the pharmacist and the physician-one of mutual respect, admiration, and friendliness'' [22].…”

Compounding Pharmacies: Who is in Charge?

“…The Court of Appeals determined that the advertising provisions of FDAMA Section 503A could not be severed; this was not challenged. Thus, FDAMA Section 503A was rendered invalid, making pharmacy compounding a legal activity that is neither regulated nor unregulated by federal authorities …”

“…Pharmaceutical companies are regulated by the FDA. However, under the provisions of the FDCA of 1938, compounding pharmacies were exempted because they were not manufacturing drugs . However, an entity that repackaged and/or relabeled products could be defined as a manufacturer and, in such cases, it would be regulated by the FDA.…”