Does your pharmacy regularly or even on rare occasions combine or mix together two or more ingredients (of which at least one is a drug or pharmacologically active component) to create a final product in an appropriate form for dosing? If yes, ACP’s Standards for Pharmacy Compounding of Non-Sterile Preparations and implementation timelines approved in 2018 apply to you.
“If you don’t think the standards apply to your pharmacy, you may want to reconsider,” said Jeff Whissell, ACP’s Deputy Registrar. “Based on what your pharmacy is currently doing or expects to do in the future, there is a good chance the standards apply to you. In order to comply with the standards, you need to carefully review them and determine if there is a gap between your practice, your practice environment, and the standards.”
The standards are accompanied by a Guidance Document for Pharmacy Compounding of Non-Sterile Preparations. Both can be found on the Standards of Practice page on the ACP website.
The college has directed pharmacy professionals to begin to identify their needs and assess gaps between the new standards and their current practice and compounding environment.
“It’s important that licensees read the new standards, use the tools provide by ACP located on our website, and perform the risk assessment,” said Jeff. “You may be surprised how many gaps you discover with the current layout of your pharmacy based on the types of non-sterile compounds you currently prepare or plan to prepare. Our advice is to complete your risk assessment as soon as possible. Accomplishing this earlier will give you more time to complete any renovations required to comply with the new standards.”
The implementation deadlines are below:
- January 1, 2020 (Priority 1) – Assessing Risks and Gaps
- January 1, 2020 (Priority 2) – Compounding and Cleaning, Personnel Training and Quality Assurance
- July 1, 2020 (Priority 3) – Facilities and Equipment
To get started, please refer to the Getting Started and Compounding Essentials documents found on the non-sterile compounding page of the ACP website.