Formulary status

Automatic stop orders Controlled-substances considerations Formulary status or tier of medication >... 

Role of New Dosage Forms in Maintaining Formulary Status... 

Conversion from one dosage form to another or from one opioid to another may be necessary in situations such as ineffective pain control, emergence of side effects, change in patient status, and in formulary restrictions. Equianalgesic doses should be I used when converting from one opioid to another. Clinicians... 

Formulary decisions Restricting broad spectrum antibiotics to infectious disease service Designating more expensive, equal-efficacy drug to nonformulary status Cost-effectiveness analyses... 

Because of increased difficulty in getting a new drug on an MCO s formulary, it is now common for pharmaceutical companies to collaborate with managed care decision makers in round table or advisory board meetings. These discussions, which normally occur before product launch or as early as phases II and III of clinical development, are helpful in determining reimbursement status and identifying potential barriers and restrictions that may be placed on the product, once approved. 

The USP methods contained in the monographs are considered validated. The USP states ... users of analytical methods described in USP-NF are not required to validate the accuracy and reliability of these methods but merely verify their suitability for use. Recognizing the legal status of the USP and NF standards, it is essential, therefore, that proposals of new or revised compendial analytical procedures are supported by sufficient laboratory data to document their validity. The Code of Federal Regulations also recognizes that USP methods are validated. The section on laboratory records [8] states Laboratory records shall include completed data derived from all tests necessary to assure compliance with established specifications and standards,... and further states if the method employed is in the current revision of the United States Pharmacopeia [or] National Formulary... and the referenced method is not modified, a statement indicating the method and reference will suffice [8]. 

Regulatory Status Complies with FDA regulation (21 CFR), for adhesives in packaging. Listed on EPA/TSCA inventory. Grades that conform to National Formulary requirements are available. Reviewed and approved for use by CTFA s CIR panel. Approved for use by MHE in Japan. CIR JACT 5(3), 1986... 

Susceptible to microbial attack. Preservation required Regulatory Status 21CFR 172.695, Food Chemicals Codex and National Formulary. TSCA registered. CAS No. 11138-66-2... 

Regulatory Status Locust bean gum meets FDA regulations 186.1343. It is also accepted as a food additive by the WHO and the Codex Alimentarius. 21 CFR 172.695. Food Chemical Codex and National Formulary Supplier Calgon... 

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