Search results
Results from the WOW.Com Content Network
The USP Controlled Room Temperature is a series of United States Pharmacopeia guidelines for the storage of pharmaceuticals; [1] the relevant omnibus standard is USP 797. [2] [3] Although 100% compliance remains challenging for any given facility, [4] the larger protocol may be regarded as constituting a form of clean room [5] which is included in a suite of best practices.
The USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF. [2] If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF".
This is a list of abbreviations used in medical prescriptions, including hospital orders (the patient-directed part of which is referred to as sig codes). This list does not include abbreviations for pharmaceuticals or drug name suffixes such as CD, CR, ER, XT (See Time release technology § List of abbreviations for those).
The law also directs the FDA to focus its post market surveillance on higher risk devices, and allows the agency to implement a reporting system that concentrates on a representative sample of user facilities—such as hospitals and nursing homes—that experience deaths and serious illnesses or injuries linked with the use of devices.
USP 800 (Hazardous Drugs—Handling in Healthcare Settings) is a guideline created by the United States Pharmacopeia Convention (USP), as one of their General Chapters through which the USP "sets quality standards for medicines, dietary supplements and food ingredients".
The aim of bioburden testing is to measure the total number of viable micro-organisms (total microbial count) on a medical device prior to its final sterilization before implantation or use. [ 2 ] 21 C.F.R. 211.110 (a)(6) states that bioburden in-process testing must be conducted pursuant to written procedures during the manufacturing process ...
In patent law, the research exemption or safe harbor exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs.According to this exemption, despite the patent rights, performing research and tests for preparing regulatory approval, for instance by the FDA in the United States, does not constitute infringement for a limited term before the end of patent ...
The first list of approved drugs, with information on how they should be prepared, was the London Pharmacopoeia, published in 1618. The first edition of what is now known as the British Pharmacopoeia was published in 1864, and was one of the first attempts to harmonise pharmaceutical standards, through the merger of the London , Edinburgh and ...