Pharmacy Practice & Operations
Regulatory & Compliance Awareness
General awareness of the regulatory landscape. Not legal advice — consult qualified counsel and your state board.
Regulatory & Compliance Awareness at a glance
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- General awareness of the regulatory landscape. Not legal advice — consult qualified counsel and your state board.
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- Tracked from official sources on 503A compounding, 503B outsourcing facilities, USP compounding standards, DSCSA & drug supply chain, State boards of pharmacy, FDA enforcement & warning letters and Drug shortages.
- Latest official record
- Eugia US LLC (f/k/a Auro Medics Pharma LLC) Issues Voluntary Nationwide Recall of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) Due to Presence of Particulate Matter (opens the source in a new tab) (U.S. Food and Drug Administration, Nov 6, 2026)
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Topic intelligenceOfficial records and reference tools from NPHLA Intelligence on the subjects closest to this topic.
- 503A compounding
- 503B outsourcing facilities
- USP compounding standards
- DSCSA & drug supply chain
- State boards of pharmacy
- FDA enforcement & warning letters
- Drug shortages
- Eugia US LLC (f/k/a Auro Medics Pharma LLC) Issues Voluntary Nationwide Recall of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) Due to Presence of Particulate Matter (opens the source in a new tab)
FOR IMMEDIATE RELEASE –November 06,2026 – East Windsor, New Jersey, Eugia US LLC (f/k/a Auro Medics Pharma LLC) is voluntarily recalling lot number 3VM26026A of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) to the hospital/healthcare facility/us…
- Par Health Issues Voluntary Nationwide Recall of Two Lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) Due to the Presence of Particulate Matter (opens the source in a new tab)
FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 8, 2026 –Par Health is voluntarily recalling two lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) to the hospital level. The product is being recalled due to the presence of particulate matter iden…
- Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin Levels (opens the source in a new tab)
IMMEDIATE RELEASE - Tomball, Texas – October 1, 2026 – Greenwich Rx, a 503A compounding pharmacy, is voluntarily recalling specific lots of its compounded glutathione to the consumer level. The product is being recalled due to potential elevated endotoxin levels.
- Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules (opens the source in a new tab)
Spectra Medical Devices is removing Sodium Chloride Flush products that were manufactured by Huons Co,. Ltd.
- Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection (opens the source in a new tab)
Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due to a potential mix-up. The affected lot of 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially conta…
- Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability (opens the source in a new tab)
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance describes the FDA's regulatory and enforce…