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FDA Announces Glycopyrrolate Will Not Be Included on 503B Bulks List

On January 27, 2022, the FDA announced its decision to not include Glycopyrrolate on the 503B bulks list. Following this announcement, outsourcing facilities will not be permitted to compound the drug-using bulk API, unless the product appears in the future on the FDA’s drug shortage list. Glycopyrrolate is not currently on the drug shortage list. Therefore, only the sterile-to-sterile process is approved for compounding this product by outsourcing facilities.

SCA Pharma is proud to produce high-quality Glycopyrrolate using our sterile-to-sterile process. Pharmacies with current or future demand for Glycopyrrolate can trust all shipments from our facility are compounded in accordance with the FDA’s requirement that this product be made through only sterile-to-sterile production.

Whereas sterile-to-sterile compounders utilize finished drug products arriving to the facility in vials or bags, API-compounders begin with non-sterile materials that must be sterilized immediately prior to filling or terminally sterilized to ensure sterility.

The FDA’s March 2019 Final Guidance indicates there are “certain benefits” to compounding drug products using the sterile-to-sterile manufacturing process. Unlike bulk drug substances, approved drug products have already “undergone premarket review for safety, effectiveness, and quality and are manufactured by a facility that is subject to premarket assessment, including site inspection.”

When the FDA determines that a drug will not be included on the 503B bulks list, production of that product from bulk API is not allowed unless the product appears in the future on the FDA’s drug shortage list.

What to look for?

503B outsourcing facilities are required to report to the FDA the source of raw materials used in their manufacturing process for all compounded products. If you are uncertain whether an outsourcer will be shipping sterile-to-sterile or non-sterile to sterile products, you can request clarification. When compounding from bulk API to alleviate a drug shortage, SCA Pharma clearly defines the raw materials used in both our catalog and online ordering portal. To place an order for sterile-to-sterile Glycopyrrolate from SCA Pharma, contact your sales representative or use our online customer portal at partner.scapharma.com.

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