A number of proposed changes to the U.S. Pharmacopeial
Convention (USP) General Chapter <797> Pharmaceutical Compounding — Sterile Preparations standards are
incompatible with the medication-use process in patient care environments, ASHP
stated in comments submitted to a USP expert panel earlier this month.
In its comment letter, ASHP points out that many of the new
requirements are more appropriate for making drugs from bulk chemicals in compounding
pharmacies or outsourcing facilities than for preparing medications for
administration in patient care settings. The letter urges the expert panel to
revise the proposals to better meet the urgent and unpredictable demands of the
typical acute patient care setting.
In addition, ASHP’s letter encourages USP to reorganize the standards
into separate sections covering basic and advanced compounding as well as the
preparation of special compounded sterile products (CSPs) such as
radiopharmaceuticals and allergenic extracts.
comments are available at here.
Members can send their feedback on the proposed revisions to firstname.lastname@example.org.