Compounding pharmacy preparations are broadly categorized as sterile or non-sterile. The distinction is important because it determines the type of facility, equipment, and processes required.
What is non-sterile compounding?
Non-sterile compounding covers a wide range of preparations that are not required to be free from viable microorganisms. Common examples include:
- Capsules
- Topical creams, gels, and ointments
- Oral liquids and suspensions
- Troches and lozenges
Non-sterile preparations are subject to pharmacy quality standards and must still be prepared carefully and consistently. However, the facility and process requirements are different from sterile compounding.
What is sterile compounding?
Sterile compounding produces preparations that are free from viable microorganisms and other contaminants. This is required for preparations that are introduced into the body in ways that bypass normal protective barriers, such as:
- Injectable preparations
- Eye drops and ophthalmic preparations
- Certain inhaled preparations
Sterile compounding requires specialized cleanroom facilities, trained personnel, and rigorous quality controls. It is subject to additional regulatory oversight and quality standards. [VERIFY SPECIFIC STANDARDS WITH CLIENT]
Why does the distinction matter?
Understanding whether a required preparation is sterile or non-sterile helps prescribers and patients understand the type of pharmacy that can provide it, the preparation timeline, and the relevant quality considerations.
Not all compounding pharmacies are equipped to provide sterile preparations. If you or your prescriber require a sterile compounded preparation, confirm with the pharmacy that it has the required facilities and processes in place.
At ACP Pharmacy
Contact ACP Pharmacy to discuss whether your prescription requires sterile or non-sterile preparation, and to confirm our current capabilities. [VERIFY STERILE COMPOUNDING SERVICE AVAILABILITY WITH CLIENT]
Last reviewed: 1 February 2024 • Reviewed by: ACP Pharmacy Compounding Team • Author: ACP Pharmacy
This content is reviewed periodically. If you notice any outdated information, please contact us.