Documentation / Records

FDA Compounding Policy and Rule Resources Updated Through September 2026

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The FDA page compiles policy documents and related materials governing human drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. Its latest listed item is final guidance dated September 4, 2026 on temporary policies for compounding certain starter parenteral nutrition drug products for neonates. It also lists an April 30, 2026 Federal Register notice on the section 503B clinical-need list for bulk drug substances, with an FDA statement proposing exclusion of semaglutide, tirzepatide, and liraglutide. Earlier entries cover bulk substances, temporary parenteral compounding policies, outsourcing facilities, insanitary conditions, current good manufacturing practice, reporting, distribution, and repackaging. The page identifies its content as current as of September 9, 2026.

Revised procedure for coordinating GMP inspections of centrally authorised products

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Version 3 of the guideline, adopted in April 2026 and entering into force on 10 September 2026, describes EMA coordination of GMP inspections conducted by EEA competent authorities for centrally authorised products. It covers pre-approval inspections, for-cause inspections and routine risk-based re-inspections, including inspection triggers, authority selection, preparation, site contacts and report submission through IRIS. The revision clarifies that, where a Supporting Authority is unnecessary, one Authority may perform both leading and supporting roles. Applicants should identify proposed manufacturing, testing and batch-release sites before submission, and all listed sites should be inspection-ready and compliant with EU or equivalent GMP from submission.

FDA Warning Letter: PReye cited for unsuitable aseptic processing and inadequate quality systems

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FDA states that its March 17–19, 2026, inspection of PReye’s drug manufacturing facility found significant finished-pharmaceutical CGMP violations. The firm manually filled multiple drug products from bulk liquid using a small flow hood on an office desk. FDA observed that the hood was neither certified nor qualified and was located in unclassified office space without HEPA filtration. FDA stated that these conditions lacked appropriate facilities, equipment, and process controls to protect products from microbiological contamination. FDA also found no quality unit function or written procedures defining its responsibilities. Basic procedures were absent, including complaint review, supplier qualification, release testing, change management, cleaning, disinfection, and deviation handling. FDA further reported missing batch numbers for sterile ophthalmic products manufactured since 2024, impairing traceability. The firm committed to cease U.S. manufacturing and distribution of PReye Vitamin SEE; it later voluntarily recalled the product because sterility testing had not been performed.

EMA Guidance on Implementing Shortage Prevention Plans

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EMA issued guidance describing how marketing authorisation holders should establish, maintain and update Shortage Prevention Plans for prescription-only human medicines in EU/EEA countries. Plans may group products sharing a supply chain, provided product-level minimum data can be supplied within two days of a request. The guidance sets out product information, patient-impact assessment, supply-chain mapping, shortage history, risk classification and proportionate management measures. It also identifies additional crisis-related information for listed critical medicines, including production and supply capacity, alternative sites and minimum stock levels. Plans should be updated after relevant changes and may form part of annual product quality review.

FDA Warning Letter: API Process Validation, Batch Records, Analytical Methods, and Stability Deficiencies

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What happened FDA states that its records review identified significant CGMP deviations at Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd., an API manufacturer. The firm manufactured and distributed APIs to U.S. 503A compounding pharmacies without adequate process validation; it had described the APIs as still in development and said formal documents, including SOPs, were not finalized. … Read more