1309 表I化学品的制造者、分销者、进口者和出口者的登记 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS 1310 列入表的化学品和某些机器的记录与报告 RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES 1311 [预留的] [Reserved] 1312 管制物质的进口与出口 ...
205 对批发处方药销售商颁发州执照的指南 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS 206 人用固体口服剂型药品的印码 IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE 207 药品生产者的登记与商业销售的药品的列表 REGISTRATION OF PRODUCERS OF DRUGS AND LISTING ...
The Food and Drug Administration (FDA) announced plans to pursue manufacturers and distributors of unapproved oral and injectable drugs containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrateen. Unapproved drug products escape the FDA's approval process, so there are safety ris...
The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List,commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administrati...
商品实物包装标签,标签需要增加drug fact 模块信息。 根据2023年11月8日FDA发布的最终指南,OTC类别的产品需要完成FDA-NDC合规要求(需要提供以下信息):: 药品名称Proprietary Name 生产商 Establishment 产品NDC CODE 给药途径route of administration 成份标签Ingredient UNll 产品包装Package NDC Code 药品分类Product ...
ANDULTRASONICRADIATION-EMITTINGPRODUCTS 第K分章―[预留的]（SUBCHAPTERK―[RESERVED]） 第L分章―根据由食品与药品管理局行政执行的某些其他法的规章（SUBCHAPTERL―REGULATIONSUNDERCERTAINOTHERACTSADMINISTEREDBYTHEFOODANDDRUGADMINISTRATION） 1210根据《联邦进口乳法》的规章REGULATIONSUNDERTHEFEDERALIMPORTMILKACT
I. INTRODUCTION This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter (OTC) drug products who have questions about the standardized labeling content and format requirements set forth in 21 CFR 201.66. The examples in this guidance illustrate various format ...
oxygen manufacturing process even though the USP does not listhydrocarbons as an impurity. Also, alternative methods may be needed to testhigh-pressurecylinders for cleaning solution residues. 不能。虽然顺磁和激光氧分析仪在正确校正的情况下是非常准确可靠的,但这类分析仪只能鉴别以及检出氧含量,而不能检...
1308 管制物质的表 SCHEDULES OF CONTROLLED SUBSTANCES 1309 表I化学品的制造者、分销者、进口者和出口者的登记 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS 1310 列入表的化学品和某些机器的记录与报告 RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES ...
Food and Drug Administration (FDA) sent a letter to all cinnamon manufacturers, processors, distributors, and facility operators in the US, reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including ground cinnamon products. The ...