MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....also known as oral and nasal metered dose inhalers respectively or MDIs) and inhalation.....establish a set of criteria to which a drug substance or drug product should conform using..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug.....used if such approach satisfies the requirements of the applicable statutes and.....made to verify that the correct label has been affixed to the container and the shield..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=99)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...Currently, a batch, or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug product.....A string label can be used by PET centers to label the immediate container provided that there is a way to associate the label with.....Equipment used in the production, processing, or packaging of a PET drug product should be..
http://www.fda.gov/cder/guidance/4259dft.htm (score=95)

Document
...number in this manner would, code requirement, and we consider drug doses of the drug.....drugs are used in hospitals, so bar codes errors involving radiopharmaceuticals, bar codes.....the outside container or wrapper (see 68 the time the drug is administered. at the unit..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.pdf (score=93)

...To ensure that a botanical drug product used in clinical trials is of consistently good quality, and.....To support expanded clinical trials, repeat-dose toxicity of a botanical drug should.....A description of the container/closure in which the botanical drug substance is to be..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=81)

stability guidance -draft
...FDA, Submission of Documentation in Drug Applications for Container Closure Systems used.....under refrigerator or freezer temperatures, or certain studies on metered dose inhalations.....between the drug and the container and closure and the potential introduction of..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=77)

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