A commercial article recognized in the USP-NF complies with USP-NF standards if it meets all the requirements specified in the article monograph, applicable general chapters, and general notices (the monograph requirements supersede the requirements of the general chapters and general announcements, in all cases where the requirements differ). The applicable standards apply at all times during the life of an item, from manufacture to expiration. Therefore, any official article must meet compendial standards when tested, and any official article that has actually been tested in accordance with the instructions in the relevant monograph must meet these standards to demonstrate compliance. The frequency of testing and sampling is left to the preferences or guidelines of those performing compliance testing and other users of the USP-NF, including manufacturers, purchasers or regulatory bodies. Therefore, any official article must meet compendial standards when tested, and any official article that has actually been tested in accordance with the instructions in the relevant monograph must meet these standards to demonstrate compliance. An FDA-approved manufacturer`s specifications and associated current Good Manufacturing Practices (GMP) for drugs and finished drugs required by FDA regulations (21 CFR Parts 210, 211) can help ensure that an item is included and meets officidal standards. As indicated in the General Notes (Section 3.10), the frequency of testing and sampling and the need for and appropriate frequency of batch testing are neither specified nor prescribed by the compendiums; Whether and when to perform testing is left to the preferences or instructions of those performing compliance testing and other users of the USP-NF, including manufacturers, purchasers or regulatory bodies. Posting Type: Letter of Intent to Review Date Published: 29-Sep-2017; updated on 05-Oct-2017*Committee of Experts: German Council of Economic Experts *This notice was updated on October 5, 2017 to correct the location of the proposed text in section 2.20. Only if a quantitative solubility test is stated in a monograph and designated as such is it a purity test. 13. In January 2017, the FDA issued a final guideline, Nonproprietary Naming of Biological Products Guidance for Industry (Final Guideline).

The final guidance describes “the FDA`s current view that biologics authorized under the Public Health Services Act have a non-generic name that includes an FDA-named suffix.” The suffix format described in the final guidance applies to original biologics, related biologics and biosimilars previously licensed and re-registered under paragraphs 351(a) or 351(k) of the Public Health Service Act (PHS Act). In accordance with final guidance, the FDA has now begun authorizing biosimilars with unique suffixes named by the FDA. Some adjustments can be made. Section 6.60 of the current USP-NF General Notices states: “Unless otherwise specified, a sufficient number of units shall be taken to ensure an appropriate analytical result.” In addition, Article 6.50.20.1 states: “If a certain concentration is required in one method, a solution of another normality or molarity may be used, provided that the difference in concentration is taken into account and that the change does not increase the measurement error.” The approximate solubility of a compendial substance is indicated by one of the following descriptive terms: In its comments on the proposed draft guidance and final guidance document proposed by the FDA, the USP acknowledged that following the FDA`s decision on its naming convention, the USP would ensure that the official names assigned by the USP are FDA-compliant. As the FDA implements its naming convention set out in the Final Guide, the revision of Section 2.20 of the General Notices is intended to ensure consistency between the USP and the FDA in the naming of biologics authorized under the PHS Act (Biologics). This revision will help address potential compliance issues by ensuring that a biologic product that receives an FDA-designated suffix does not violate an applicable USP monograph. At the same time, the additional language provides flexibility and allows different pharmacy approaches to be applied in situations where products have the same base name but have different suffixes. USP remains committed to advancing our common goal of protecting and promoting public health, and therefore believes it is important that the FDA`s naming convention be implemented in a consistent and coordinated manner to eliminate errors between names and avoid potential problems for manufacturers. As USP continues to engage stakeholders, USP would welcome input to this proposed revision, including any compliance concerns, by October 27, 2017. Please send your submissions, questions or comments to Jessica Simpson, Manager, Pharmacy Operations (301-816-8231 to JCS@usp.org).

A monograph may contain information about the description of the article. Information about the “description and solubility” of an article can also be found in the Description and relative solubility reference table of USP and NF articles. The reference table refers only to the characteristics of articles that meet monographic standards. The reference table is primarily intended for those who use, prepare and dispense medicinal products and/or related articles. Although the information contained in the monographs and the information contained in the Reference Table may be indirectly useful in the preliminary assessment of a product, they are not intended to serve as a standard or purity test.