New Sterile Compounding FAQs

The January 1, 2019 deadline for the implementation of the Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations and the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations is quickly approaching.

As previously discussed, full compliance on all elements of the standards is expected by January 1, 2019. If a pharmacy has expressed to the College that it needs additional time to ensure compliance with the standards, then the expectation is that all critical elements of the standards will be fully met by January 1, 2019 and that the pharmacy will have in place an action plan towards full compliance. Read more on the Sterile Compounding Key Initiative.

To assist pharmacies and pharmacy professionals in preparing for the standards, the College has posted new Frequently Asked Questions on our website.

Questions include:

• What is required for January 1, 2019?
• What happens if our pharmacy is not able to meet the critical elements by January 1, 2019?
• What are the next steps for organizations that are not fully compliant with the NAPRA Model Standards for Pharmacy Compounding of Sterile Preparations by January 1, 2019 but have met the critical elements?
• Who can be a sterile Compounding Supervisor (CS) and what are they responsible for?
• Where can I find a “third party evaluator” to evaluate the sterile compounding supervisor?
• Do you have any suggestions or recommendations to aid us in requests regarding potential capital projects required to meet standards by January 1, 2019?
• Are there opportunities for regional models?
• Whom should I contact about specific questions that I have about operational procedures and polices?
• What are the College’s expectations for Beyond-Use-Dating (BUD)?
• What training and certification programs are recommended?
• What is required when organizations/pharmacies respond to assessment report action plans?
• How do I submit and respond to an action plan?
• What are the requirements for environmental testing?
• Does our hospital need to be concerned about the sterile implementation guidelines if there is no pharmacy on site?

Please take the time to review the College’s Sterile Compounding Key Initiative and Frequently Asked Questions to ensure your pharmacy is prepared well in advance of the deadline.