LAKE FOREST, Ill., Jan. 27, 2014 /PRNewswire/ -- In the two months since the Drug Quality and Security Act (DQSA) was signed into law, 11 compounders have registered a total of 14 facilities as "Outsourcing Facilities" per the U.S. Food and Drug Administration's (FDA's) Registered Outsourcing Facilities Web page, dated 1/17/14. This includes PharMEDium Healthcare Corporation, the largest compounder in the category, which has registered all four of its facilities.
The law, which calls for large-scale entities engaged in nonprescription compounding to voluntarily register with the FDA and comply with guidelines under the newly created section 503B of the Federal Food, Drug, and Cosmetic Act, has been recognized for the potential to improve patient safety. What hasn't been discussed with as much vigor is the protection DQSA also affords hospitals/health systems and other healthcare providers.
"It's extremely important for hospitals and other healthcare providers to work with FDA-registered compounders as FDA has advised. Not doing so could ultimately affect the provider in several ways. There may be patient safety implications, drug supply, and compliance issues, which ultimately could affect accreditation. Reimbursement issues from payers cannot be ruled out as well," said Andrew J. Donnelly, PharmD, MBA, FASHP, Director of Pharmacy Services, University of Illinois Hospital & Health Sciences System, which outsources a number of compounded drugs.
As a long-time advocate for clearer FDA authority and stronger oversight, PharMEDium has been voluntarily registered with the FDA since the company's inception—more than a decade before the passage of the new law. The company's support of the federal oversight continues with the preparation of its required Interim Product Reporting for Human Drug Compounding Outsourcing Facilities, and the early development of innovative solutions and processes to meet and exceed 503B requirements.