1. Compounding certain beta-lactam products in shortage under Section 503A of the Federal Food, Drug, and Cosmetic Act: immediately in effect guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2022 Subject(s): Anti-Bacterial Agentsbeta-LactamsDrug CompoundingGovernment RegulationLegislation, DrugUnited StatesUnited States. Food and Drug Administration
2. Q13 continuous manufacturing of drug substances and drug products: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2023 Subject(s): Biological ProductsDrug CompoundingDrug DevelopmentDrug IndustryGovernment RegulationUnited States
3. Reformulating drug products that contain carbomers manufactured with benzene: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023 Subject(s): BenzeneDrug CompoundingDrug IndustryGovernment RegulationLegislation, DrugPharmaceutical PreparationsUnited States