The compounding pharmacy industry has seen tremendous change in federal and state regulation, and the future promises even more changes with the proposed US Pharmacopeia (USP) Chapter 800. For some compounding pharmacists, the new regulations may have raised more questions.
On June 24, 2015, Eric S. Kastango, M.B.A., B.S.Pharm., FASHP will review activity surrounding USP Chapter 797 in today’s environment, the proposed USP Chapter 800 and recent activity by the Food and Drug Administration that affects compounding pharmacies in a one hour webinar hosted by Pharmacy OneSource. Pharmacists will want to attend to learn more about:
The impact of the Drug Quality and Security Act: Passed in 2013, the Drug Quality and Security Act (DQSA) laid the foundation for a new electronic drug tracking system, limits the sale of compounded sterile products across state lines without a memorandum of understanding the with FDA and requires communication between state boards of pharmacy and the FDA. It also established a new category of outsourcing facilities for compounding pharmacies that prepare compounded sterile preparations (CSPs) for sale beyond the amount called for by current or historical prescription levels.1
503B Outsourcing Facilities: Over the past year, the FDA has issued a number of guidance documents presenting the manufacturing and reporting standards that it will apply during inspections of compounding pharmacies that have registered as outsourcing facilities. Pharmacists should be aware of the specific Good Manufacturing Practices as well as the new reporting, labeling, registration and fee requirements that apply to outsourcers. Facilities that purchase CSPs will also want an understanding of the advantages of buying from a registered outsourcing facility and how to conduct due diligence.2
What’s happening with Form 483: FDA Form 483, “Notice of Inspectional Observations,” lists any violations of the Food Drug and Cosmetic Act observed by an FDA inspector during a pharmacy inspection. While it does not list every possible violation of relevant regulations, it does document practices or conditions that has or may result in adulterated or otherwise contaminated products. Depending on the organization’s response to Form 483, the FDA may issue a warning letter that advises the organization has significantly violated FDA regulations. From 2012 to 2014, the FDA conducted 150 compounding pharmacy inspections and issued Form 483s or warning letters to 27 compounding pharmacies and seven outsourcing facilities.3,4
What’s in Chapter 800: USP Chapter 800, “Hazardous Drugs--Handling in Healthcare Settings,” outlines the proper handling of hazardous drugs from receipt through compounding, storage, administration and disposal. The proposed chapter categorizes as hazardous all medications in the National Institute for Occupational Safety and Health’s list of antineoplastic hazardous drugs. Comments on the proposed, enforceable new chapter closed on May 31. While pharmacies may not be held to the standards established in Chapter 800 until 2016 or later, many in the industry recommend that pharmacies act to comply as soon as possible, particularly as the storage requirements may pose a challenge for many facilities.5
New draft guidance on the compounding of biologics and repackaging: New guidelines require that any biologic mixed, diluted or repackaged must be administered within four hours, unless it microbial testing or other studies are performed. The guideline does not just apply to compounding pharmacies, but to anyone who compounds products, as many physicians and nurse do in a hospital setting.6, 7
Webinar presenter Eric S. Kastango is president of Clinical IQ LLC, a health care consulting firm and CriticalPoint, LLC, a web-based education company. He has practiced pharmacy for more than 30 years in community, hospital and home care settings. He has also managed a FDA-registered cGMP manufacturing operation for Baxter Healthcare Corporation. Eric received the 2014 NABP Henry Cade Memorial Award for his assistance to the states and NABP to address the compounding tragedy that occurred in 2012. A Fellow of the American Society of Healthcare Pharmacists, he served on the USP Sterile Compounding Committee from 2005-2010 and is currently an expert consultant to the USP. Eric actively works with NABP and state boards of pharmacy to provide training to their sterile compounding inspectors.
What questions do you have about the new regulations for CSPs?
Shah M. DQSA: New regs give FDA broader powers over compounding. Drug Topics. June 10, 2014.
FDA Implementation of the Compounding Quality Act. Outsourcing Facility Registration and Reporting. FDA.gov. Updated May 26, 2015.
FDA Form 483 Frequently Asked Questions. Inspections. Inspections, Compliance, Enforcement, and Criminal Investigations. FDA.gov. Updated April 23, 2015.
Buckley B. DQSA Making an Impact on Sterile Compounding. Pharmacy Practice News. Feb. 2015.
Traynor K. Prepare Now for USP Standard on Handling Hazardous Drugs. Pharmacy News. ASHP. April 1, 2015.
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities. FDA.gov. Feb. 13, 2015.
- Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application. FDA.gov. Feb. 13, 2015.