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The United States Pharmacopeia (USP) and National Formulary (NF) are the official standards for all prescription and over-the-counter medicines, dietary supplements, excipients and other healthcare products manufactured and sold in the United States.
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The USP Drug Classification (USP DC) is an independent drug classification system developed in response to stakeholder input that it would be helpful to have a classification system beyond the Medicare Model Guidelines (MMG), to assist with formulary support outside of Medicare Part D.
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USP Reference Standards are highly characterized specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators used in conducting tests and assays for USP–NF and FCC.
the USP Drug Classification system (USP DC) is an independent drug classification system currently under development by the USP Healthcare Quality Expert Committee. The USP DC is designed to address stakeholder needs emerging from the extended use of the USP Medicare Model Guidelines (USP MMG) beyond the Medicare Part D benefit.
The law elevated the public health role of the United States Pharmacopeia because it defined a drug as “all medicines and preparations recognized in the United States Pharmacopeia (USP) or National Formulary (NF),” and defined adulterated drugs as those referenced in the USP and NF but differing from “the standard of strength, quality, or purity” specified in the two compendia.
In accordance with the Rules and Procedures of the 2015–2020 Council of Experts, USP revised the official date of Hazardous Drugs—Handling in Healthcare Settings <800> to December 1, 2019. The official date of <800> was previously postponed. to align with the revisions to Pharmaceutical Compounding—Nonsterile Preparations <795> and
© 2019 USP A hierarchy of non-sterile drug dosage forms with potential risk (high to low) to end users from a microbial contamination perspective is: – Metered-dose and dry powder inhalants – Nasal sprays – Otics – Vaginal suppositories – Topicals – Oral liquids (aqueous) – Oral liquids (non-aqueous) – Rectal suppositories – Liquid-filled capsules
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USP <61> lists several potential neutralizing agents, based on the offending interfering substance. The most widely used compounds are lecithin and polysorbate 80. This combination of neutralizers will typically inactivate most quats, parabens, iodine, and bisbiguanides.