2003 Compounding Documentation 
The Checkup by Singlecare
APRIL 17, 2024
Legislation passed in 2003 prohibits Medicare from covering drugs prescribed specifically for weight loss, and while Medicaid has more flexibility here, not every state will cover them. According to Dr. Bonza, these requirements might include a documented diagnosis of Type 2 diabetes mellitus and confirmation with a medical test.
ISPE
NOVEMBER 2, 2022
ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Five successful conferences drove financial performance more than expected, and guidance documents have been very strong.
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Druggist
FEBRUARY 17, 2021
Histamine is a compound which commonly causes allergic reactions, including allergic rhinitis (hayfever). Insect venoms (wasps) contain several allergens, which cause unpleasant symptoms, and in some cases, may cause an anaphylactic reaction (Moffitt, 2003). Histamine, a is one compound which is realised after insect bite occurred.
ISPE
MAY 9, 2023
Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.
ISPE
OCTOBER 26, 2022
Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. Manufacturing of (or with) high-potent compounds in adjacent suites may be possible with the appropriate engineering controls and risk assessments based on toxicity data.
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