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Non-sterile compounding compliance deadlines fast approaching

December 11, 2019
There’s less than a month to go for pharmacies to meet the first two priorities of the non-sterile compounding standards.

Licensed pharmacies that provide or plan to provide non-sterile compounding services must meet the first two priorities of ACP’s Standards for Pharmacy Compounding of Non-Sterile Preparations by January 1, 2020.

Priority One involves assessing the risks and gaps that exist in your pharmacy. To meet this priority, pharmacy teams must review the compounds they make or plan to make, complete a risk assessment for each compound, and determine what changes to their infrastructure or additional training may be necessary.

Priority Two focuses on compounding and cleaning, personnel training, and quality assurance. To comply with this priority, pharmacy teams must address training for staff, and develop policies and procedures to meet the standards, including a quality assurance program.

ACP has developed resources for pharmacy teams working to comply with the standards. The resources—available on ACP’s non-sterile compounding page—include the Getting Started document, Compounding Essentials, Non-sterile Compounding FAQs, and more.

The third priority, which deals with facilities and equipment, must be met by July 1,2020.

Remember, even if your pharmacy does not provide or plan to provide non-sterile compounding services, your pharmacy must meet ACP’s foundational requirements for licensed pharmacies. As such, all licensed pharmacies must have an area for compounding drugs and be equipped to provide compounding services. Equipment required for all pharmacies includes

  • sink with hot and cold running water,
  • heat source for extemporaneous compounding,
  • prescription or electronic balance with a sensitivity to a minimum of 10 mg,
  • set of metric weights or a calibration weight, and
  • any other equipment required to support the professional services that are provided in the dispensary.

The complete foundational requirements are available on the licensee resources page of the ACP website.