Missouri Board of Pharmacy - Drug Shortages Due to Recent Hurricanes
Missouri DCI sent this bulletin at 10/14/2024 08:00 AM CDT|
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Drug Shortages Due to Recent Hurricanes
The Board Office has received questions regarding potential drug shortages due to recent hurricanes. The Board is issuing the following guidance to assist licensees that may be affected:
Class B Hospital Pharmacy Compounding for Drug Shortages
Class B pharmacies are reminded that regulation 20 CSR 2220-2.410 Class B Hospital Pharmacy Compounding for Drug Shortages allows the compounding and distribution of non-patient specific compounds for drug shortages. Please review the entire rule to ensure compliance. For sterile preparations, the regulation requires Class H on the pharmacy’s license and compliance with 20 CSR 2220-2.2.00 Sterile Compounding. The repackaging of a sterile product is sterile compounding. Both regulations may be found here.
Patient Specific Compounding
Regulation 20 CSR 2220-2.400 Compounding Standards of Practice allows a pharmacy to compound a commercially-available product due to a drug shortage. The pharmacy must confirm and document the commercially available product is not available despite due diligence. Please review the entire regulation to ensure compliance.
Foreign Drug Imports
FDA has approved imports from foreign manufacturers to help alleviate these shortages. See FDA’s webpage for these approvals. Board regulation 20 CSR 2220-5.020 includes the following exemption from drug distributor licensure:
- The sale, purchase, transfer, or trade of a prescription drug to alleviate a temporary shortage of a prescription drug that is in limited supply or unavailable due to delays in or interruption of supply. Drugs sold, purchased, transferred, or traded pursuant to this section shall only be sold, purchased, transferred, or traded directly from an importer or manufacturer authorized by or registered with the United States Food and Drug Administration (FDA) to import or manufacture the drug that is unavailable or in short supply. In addition, sales, purchases, transfers, or trades shall be limited to the period of shortage and to the drug that is unavailable or in limited supply. Documentation of FDA authorization or registration shall be maintained in the licensee’s or recipient’s records;
More Information
Baxter: https://www.baxter.com/baxter-newsroom/hurricane-helene-updates
If you have further questions, please contact your inspector or the Board office.
