FDA Releases Draft Guidance for 503B Compounding Facilities

Integrated Medical Systems, Inc. > News > FDA Releases Draft Guidance for 503B Compounding Facilities

FDA Releases Draft Guidance for 503B Compounding Facilities

The FDA released a 48-page draft detailing guidance for 503B compounding facilities intended to help facilities stay in compliance with Current Good Manufacturing Practice (CGMP). Updates include providing clarity on quality assurance, maintaining suitable facilities, sterility, stability testing and beyond-use or expiration dates for products that don’t go through the FDA drug approval process.

Guidelines were drafted to ensure compounded product quality and reduce contamination risks, and will help advance policies that make it more feasible for outsourcing facilities to fulfill requests for office stock while maintaining product quality. Click here to view the article from Pharmacy Practice News.

Integrated Medical Systems, Inc. understands your need to reduce risk in your controlled environment. The IMS Cleanroom Product Catalog offers a comprehensive selection of sterile single-use protective clothing and environmental testing products to help your 503B Drug Compounding Facility stay in compliance with the updated Current Good Manufacturing Practice (CGMP) guidelines.

The IMS Cleanroom Product Offering Includes:

(Click on the item to view in the IMS Portal)

  • Coveralls
  • Masks
  • Air Samplers* (Contact your IMS Sales Rep for ordering information)

For more information on USP Cleanroom Products, contact your IMS Sales Representative or email us at [email protected]

If you are not a current customer of IMS and would like more information on USP Cleanroom products, please call customer service at (800)755-3800 to be connected with an IMS Sales Representative in your area.

USP 797 compliance requires that the preparation of pharmaceuticals occur in ISO Class 5 (Class 100) clean room with a buffer area of ISO Class 7 (Class 10,000) plus ante-areas of at least ISO Class 8 (Class 100,000).

USP <800> is the new chapter which describes practice and quality standards for handling Hazardous Drugs (HDs) to promote patient safety, worker safety, and environmental protection.

IMS products specifically designed for use in clean areas of compounding pharmacies. Our products are used to clean and sanitize clean rooms and labs. 

IMS serves the following industries: 

–   USP <797> Compliance 
–   USP <800> Compliance 
–   Sterile Compounding Pharmacies 
–   cGMP Compliance – Current Good Manufacturing Practices 


Customer Service:

Email: [email protected]
Phone: 1.800.755.3800

Integrated Medical Systems, Inc.
12600 Holiday Drive
Alsip, Illinois 60803

    Related Posts