ASPS to USP on In-Office Compounding
The U.S. Pharmacopeia (USP) Expert Committee recently published a revised set of standards to ensure the safety of compounded medications. These revised standards were drafted due to a large volume of public comments, as well as significant feedback from stakeholders during roundtable meetings and discussion forums over the last three years.
While generally less restrictive than their previous proposal, ASPS is concerned with some aspects of the proposed changes to Chapter 797 on enforceable sterile compounding standards. In comments, ASPS noted that the FDA has acknowledged that physician offices should not be included in any definition of compounding facilities. Additionally, ASPS asked for a review of the proposed time-frame for in-office compounding. The Society's comments mirror concerns raised by many specialty societies, all of which seek to lengthening the time to mix, prepare and dilute drugs used in the office setting. Without a change to the language in this latest proposal, physicians may be unable to prepare and administer medications, such as buffered lidocaine, to their patients in the clinical setting without unreasonable burdens.
In-office compounding is regulated by multiple government bodies. Physicians are expected to not only follow FDA and state guidance regarding good compounding practices, but also guidance from the USP. Chapter 797 was the first set of enforceable sterile compounding standards created by the USP. Prior to 2008, pharmaceutical schools were slow to adopt universal sterilization standards, and budget constraints held many back from complying with regulations. After a wide-spread fungal meningitis outbreak in 2012, which was linked to contaminated medications compounded at a pharmacy not in compliance with regulations, the organization proposed changes to Chapter 797.
ASPS expects the USP will need several months to review comments and offer additional compromises on changes to Chapter 797.