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 and are in effect as of July 1, 2021. All pharmacies must meet Level A non-sterile compounding requirements. Those providing higher levels of non-sterile compounding must additionally meet the requirements of the type and level of compounding being provided. The expectation is that all pharmacies are compliant with these standards.
If you are planning on opening a new pharmacy, please refer to our getting started document and compounding essentialsto ensure that you meet the standards prior to the pre-opening inspection.
Additional resources
- Non-sterile compounding FAQs
- Non-sterile policies and procedures template
- 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 (fillable PDF)
- Template for master formulation record (fillable PDF)
- Template for incident/accident reporting (fillable PDF)
- Template for risk assessment (fillable PDF)