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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.
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".
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]
Methylprednisolone (Depo-Medrol, Medrol, Solu-Medrol) is a synthetic glucocorticoid, primarily prescribed for its anti-inflammatory and immunosuppressive effects. [4] [5] [6] It is either used at low doses for chronic illnesses or used concomitantly at high doses during acute flares.
One exception occurred during the 2010 Swine Flu Epidemic when the FDA authorized expired Tamiflu based on SLEP Data. [9]The US FDA is able to extend the shelf life of drugs throughout national, state, local, tribal, and territorial stockpiles through two legal means: by issuing an Emergency Use Authorization on using a drug past its expiration date (which is legally an unapproved use of a ...
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 ]
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.
Andexanet alfa, sold under the brand name Andexxa among others, is an antidote for the medications rivaroxaban and apixaban, when reversal of anticoagulation is needed due to uncontrolled bleeding. [8]