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.
- In the Knowledge Hub
- Content on this topic is in development.
- Live intelligence
- 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
- Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules (opens the source in a new tab) (U.S. Food and Drug Administration (MedWatch), Sep 18, 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
- 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…
- B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter (opens the source in a new tab)
FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of partic…
- Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees (opens the source in a new tab)
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Reg…
- Implementation of an automated robotic syringe-filling device in a hospital-based sterile products cleanroom (opens the source in a new tab)