Standards for Pharmacy Compounding of Non-sterile Preparations
The Standards for Pharmacy Compounding of Non-Sterile Preparations and the Guidance Document for Pharmacy Compounding of Non-Sterile Preparations were approved by ACP Council in 2018.
The implementation framework will give pharmacy professionals the requirements needed to adapt their facilities, policies, and procedures. The three phases spread the changes out over two years to ensure successful implementation.
The compliance deadlines for the Standards for Pharmacy Compounding of Non-Sterile Preparations are as follows:
- The compliance deadline for Priority One: Assessing risks and gaps is January 1, 2020.
- The compliance deadline for Priority Two: Compounding and cleaning, personnel training, and quality assurance is January 1, 2020.
- The compliance deadline for Priority Three: Facilities and equipment is July 1, 2020.
Please refer to our getting started document to begin, as well as the compounding essentials.
Additional resources
- Non-sterile Compounding FAQs
- Non-sterile compounding self-assessment
- Master formulation record vs compounding record
- Risk assessment example 1: Diclofenac
- Risk assessment example 2: Hydrocortisone 1% / Ketoconazole 2% 1:1 cream
- Non-sterile compounding references
- Template for developing a procedure (PDF, editable)
- Template for developing a procedure (Word, editable)
- Template for master formulation record (PDF, editable)
- Template for master formulation record (Word, editable)
- Template for incident/accident reporting (PDF, editable)
- Template for incident/accident reporting (Word, editable)