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Under section 503B of the Federal Food, Drug, and Cosmetic Act, large outsourcing facilities may only compound from bulk active ingredients in two situations: the ingredient appears on the 503B bulks list, meaning FDA has found a clinical need for it, or the finished drug sits on FDA's shortage list at the time of compounding

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Additionally, the order addresses amendments, verification, and a resolution process for deficiencies and disputes, specifying timelines for electronic submission of the PFS and related documents via the Rubris Crosslink system while ensuring the confidentiality of medical and financial data

Carriers have impaired conjugation of small reactive metabolites including dichloromethane, ethylene oxide, and certain therapeutic alkylating agents

Elderly researchers may require dose adjustments and closer monitoring

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