STATE | State Boards of Pharmacy Turn their Attention to Physician In-Office Compounding
Some state pharmacy boards have started looking to regulate physician in-office compounding and reconstitution of drugs. Regulation and oversight of pharmaceutical compounding has been steadily increasing after a 2012 national crisis was sparked by an outbreak of fungal meningitis that was linked to contaminated compound drugs sourced from the New England Compounding Center. ASPS agrees that it is of the utmost importance that patients receive the safest and most effective drugs. However, unnecessarily increasing the regulatory burden on practitioner's offices will needlessly increase the cost of and reduce access to care. This month, ASPS has submitted comments to the North Dakota Board of Pharmacy (ND Board) and the State of Ohio Board of Pharmacy (OH Board) attempting to protect physician's rights to compound and reconstitute drugs in-office.
In North Dakota, a proposed regulation regarding pharmaceutical compounding could be interpreted to require physician offices to register as drug compounding facilities in order to use compounded drug products in their offices. After submitting comments, ASPS has been communicating with the ND Board, and has learned that it is not the board's intent to prevent physician offices from compounding or reconstituting drugs. The ND Board is currently considering language revisions to clarify that the rule only intends to regulate pharmacies. ASPS will continue to work with the ND Board on this issue.
On May 1, a regulation in Ohio requiring all physician practices to register as a type of drug distribution facility in order to compound or reconstitute drugs in-office was scheduled to go into effect. The OH Board received a great deal of negative feedback from the physician community indicating that they were unaware of the need to obtain the additional license. Due to this feedback, the OH Board has extended implementation of this rule until September 1, 2016. Additionally, the OH Board is scheduled to discuss the rule change during its June 2016 meeting. ASPS and a number of other physician groups that would be negatively impacted by the rule change have submitted comments for the OH Board's consideration.
The Federal Perspective
The United State Pharmacopeia (USP) drafted revision to chapter 797 of the United States Pharmacopeia Reference Standards regarding pharmaceutical compounding earlier this year. These standards, if promulgated as written, would have increased the regulatory burden and audit requirements on physician practices compounding and reconstituting drugs. ASPS commented requesting that the proposed changes be reconsidered because of the negative impact on physicians and their practices. Over 8,000 comments were received in response to the proposed revisions. Based on their evaluation of the public comments, the USP has indicated that it will host two roundtables to seek clarity on specific areas of concern, and has indicated it will most likely publish a revised document, with a second public comment period.
ASPS is closely watching attempts to regulate physician office compounding standards at the national and state level, and will continue to advocate for standards that make sense for plastic surgeons and their patients.