The International Academy of Compounding Pharmacists (IACP) has submitted formal comments to the United States Pharmacopeial Convention (USP) regarding General Chapter <797>. These comments are based upon IACP member input as well as the input of the IACP Legislative Committee and Board of Directors. Thank you to all members who provided feedback.
IACP General Chapter <797> Comments
IACP supports practices and quality standards for preparing compounded sterile human and animal drugs. However, IACP has strong concerns with several of the proposed revisions that would place an undue burden upon pharmacists and result in decreasing time spent with patients as well as patient access to vital compounded medications. At a time when patients are already facing decreased access to compounded medications due to skyrocketing drug shortages and new burdensome regulations, the Revised Chapter <797> will result in further decreasing patient access to these vital compounded medications. The burden that these revisions place on pharmacists will result in many pharmacists foregoing sterile compounding altogether resulting in further reducing patient access to medications. The sections within the Revised Chapter <797> that will burden pharmacists the most and have the greatest impact on decreasing patient access are the sections related to air quality monitoring, establishing beyond-use dates, and in-use times are of greatest concern.
IACP shares the concerns of many other organizations that the current revisions provide very few citations in support of the specific proposed requirements. As the burden that is being placed on pharmacists is so high by these revisions as to lead to drastically reducing patient access to medications, IACP strongly encourages that any revisions proposed be based on data, studies, and specific information.
Therefore, while IACP appreciates USP’s work on this issue, IACP has strong concerns as to the unintended consequences of the proposed revisions on patient access to medications. IACP urges USP to consider patient access to compounded medications and revise the proposed revisions as detailed in our comments.
PLEASE NOTE: USP Extended the Comment Period to TODAY, Monday, February 1, 2016
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