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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.
USP establishes documentary (written) and reference (physical) standards for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.
The United States Pharmacopeia (USP) outlines several tests that can be done to quantitatively determine the bioburden of non-sterile drug products. [ 4 ] It is important when conducting these tests to ensure that the testing method does not either introduce bacteria into the test sample or kill bacteria in the test sample. [ 4 ]
The labeled expiration date is a manufacturer's promise for a time until which the drug will have full efficacy and be safe as manufactured. [4] The labeled expiration date is not an indication of when a drug has become ineffective or unsafe to use. [4] Many drugs are effective for years after their expiration dates. [4]
Dosage forms (also called unit doses) are pharmaceutical drug products presented in a specific form for use. They contain a mixture of active ingredients and inactive components (), configured in a particular way (such as a capsule shell) and apportioned into a specific dose.
Birth control pills in blister packs. Formed solid unit doses of pharmaceuticals (capsules, suppositories, tablets, etc.) are commonly packed in blister packs.In Europe about 85% of solid unit doses are packed in blister packs with only about 20% in North America.
Dexmedetomidine can also be used for procedural sedation such as during colonoscopy. [18] It can be used as an adjunct with other sedatives like benzodiazepines, opioids, and propofol to enhance sedation and help maintain hemodynamic stability by decreasing the requirement of other sedatives.
Methohexital or methohexitone (marketed under the brand names Brevital and Brietal) is a drug which is a barbiturate derivative. It is classified as short-acting, and has a rapid onset of action. [2]