In a recent article published in Drug Topics, NABP shares tools and resources to prepare for an inspection or accreditation on-site survey. NABP’s accreditation programs are intended to verify the quality and safety of pharmacy and wholesale distributor operations. Businesses can prepare for an on-site inspection, accreditation, or review by evaluating policies and procedures, conducting […]

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Food and Drug Administration (FDA) is requiring changes to the prescribing labels for tranexamic acid injections after receiving medication error reports of the acid administered intrathecally or as an epidural injection. Tranexamic acid injection is intended for short-term use to reduce or prevent hemorrhage in patients with hemophilia and should only be administered intravenously. The […]

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Food and Drug Administration (FDA) has proposed streamlining its biosimilar products research process. The agency is also planning to advance interchangeability to allow biosimilars to be interchangeable with brand-name biologics. FDA argues that comparative efficacy studies may not be necessary for supporting a demonstration of biosimilarity and instead recommends developers consider conducting a comparative analytical […]

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Nominations are now being accepted for the 2026 NABP Leadership Awards. The Leadership Awards highlight individuals and organizations at the forefront of pharmacy regulation, showing us all what it means to be a leader in public health protection. Complete and submit the nomination form by December 31, 2025, to be considered. Nomination criteria and descriptions […]

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Food and Drug Administration (FDA) is requiring that all labels for opioid pain analgesics clarify the risks associated with long-term use. The updated labels will include the following: Additionally, the phrase “extended treatment period” will be removed to avoid the misinterpretation that taking opioids over an indefinite period is safe. More information is available on […]

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All Food and Drug Administration (FDA)-regulated products imported into the United States will now be reviewed and subject to FDA requirements, according to US Customs and Border Protection’s (CBP’s) inspection policy. Previously, “de minimis shipments,” or low-value shipments, of FDA-regulated products were exempt from this review. However, CBP reported that de minimis shipments were exploited […]

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The United States Department of Health and Human Services (HHS) will require vaccine manufacturers to remove the mercury-based preservative thimerosal from all influenza vaccines distributed in the US. According to an HHS press release, this action follows Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices’ recent recommendation from its June 2025 meeting.

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Pursuant to Section 105 of the Drug Quality and Security Act (P.L. 113-54), Food and Drug Administration recently shared actions taken by the State of Texas against three local compounding pharmacies for operating in violation of the Texas State Board of Pharmacy Rules. Their cases are described below: For more information on these Board orders, […]

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The International Pharmaceutical Federation (FIP) has published an updated version of its vaccination reference guide for pharmacists. The 2025 version of the FIP Knowledge and Skills Reference Guide for Professional Development in Vaccination Services expands on the roles of pharmacists in reducing vaccination hesitancy, improving vaccine uptake, and maintaining proper storage, handling, and distribution procedures […]

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There were 98 drug shortages in 2024, with 89% of those drugs first reported in shortage in 2023, according to the new drug shortage report published by United States Pharmacopeia (USP). The USP Annual Drug Shortages Report: Long-Standing Drug Shortages Persist in 2024 notes that the average duration of a drug shortage was more than […]

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