...Remember that you can have a 2 single-dose container or a multi-dose vial in 3 addition to.....If you are using as an inactive 5 ingredient a product that is marketed as a finished 6 drug.....I know in the 2 community out there the multiple dose container 3 term is used rather loosely..
http://www.fda.gov/cder/regulatory/pet/0521pet.doc (score=100)

Human Drug Notes
...Unless the multi-dose container is labeled to yield a specific number of doses of a stated.....The retention time is at least one year after the expiration date of the drug product, or, in.....The expiration date assigned to a new batch of finished drug product should be calculated from..
http://www.fda.gov/cder/hdn/hdn995.htm (score=54)

X:TRANSFERGUIDANCEFINAL 807FN1.PDF
...warning statements and unit-dose packaging for solid oral drug products that contain 30 mg.....products needs to be evaluated over time in the same container-closure system in which the.....on the product in its new packaging, and expiration dating must reflect the results of the..
http://www.fda.gov/cder/guidance/1807fn1.pdf (score=38)

MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....elastomeric, plastic components or coatings of the container and closure system when in.....also known as oral and nasal metered dose inhalers respectively or MDIs) and inhalation..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=25)

Guidance for Industry: Container Closure Systems for Packaging Human Drugs...
...This test measures the water vapor permeation of a single-unit or unit-dose container closure.....and secondary packaging components that provide protection to the drug product or for which.....A liquid-based oral drug product typically needs to be protected from solvent loss,microbial..
http://www.fda.gov/cber/gdlns/cntanr.pdf (score=23)

Container Closure Systems for Packaging Human Drugs and Biologics
...For a blow/fill/seal product, extractables should be evaluated on the formed drug product container.....This test measures the water vapor permeation of a single-unit or unit-dose container closure.....A repackager is a firm that buys drug product from the drug product manufacturer or distributor and repackages it for..
http://www.fda.gov/cder/guidance/1714fnl.htm (score=22)

Guidance for Industry - Container Closure Systems for Packaging Human Drugs...
...For a blow/fill/seal product, extractables should be evaluated on the formed drug product container.....This test measures the water vapor permeation of a single-unit or unit-dose container closure.....A repackager is a firm that buys drug product from the drug product manufacturer or distributor and repackages it for..
http://www.fda.gov/cber/gdlns/cntanr.htm (score=22)

...7, changes in the container closure system that result in drug product contact with a component material that has never been used in.....20]A container closure system that is considered to control the dose delivered to the.....A change in the container closure system for a nonsterile drug product, based on a showing of equivalency to the approved system..
http://www.fda.gov/cder/guidance/3516fnl.doc (score=21)

Changes to an Approved NDA or ANDA
...A change in the container closure system for a nonsterile drug product, based on a showing of equivalency to the approved system.....dose delivered to the patient or the formulation modifies the rate or extent of.....A drug product labeling change includes changes in the package insert, package labeling, or..
http://www.fda.gov/cder/guidance/2766fnl.htm (score=21)

þÿ
...route of administration of the drug product, performance of the container closure system, and the likelihood of interaction.....20A container closure system that is considered to control the dose delivered to the.....A change in the container closure system for a nonsterile drug product, based on a showing of equivalency to the approved system..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1999d-0529-gdl0003.pdf (score=21)

þÿ
...route of administration of the drug product, performance of the container closure system, and the likelihood of interaction.....20A container closure system that is considered to control the dose delivered to the.....A change in the container closure system for a nonsterile drug product, based on a showing of equivalency to the approved system..
http://www.fda.gov/cder/guidance/3516fnl.pdf (score=21)

...Three comments concerned the proposed exemption of drug product salvagers from drug listing in.....17 that when single-dose containers are packed in individual cartons, the expiration date.....container should not be a part of the regulations at this time, and this requirement is..
http://www.fda.gov/cder/dmpq/preamble.txt (score=21)

stability guidance -draft
...If testing of the drug product in the immediate container or as marketed is needed, the samples.....under refrigerator or freezer temperatures, or certain studies on metered dose inhalations.....Stability data should be developed for the drug product in each type of immediate container and..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=17)

Packaging
...If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier of a.....When metered-dose valves are used, full information is also necessary with respect to.....It is also possible for a component of the drug product to migrate through the walls of the..
http://www.fda.gov/cder/guidance/package.htm (score=17)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....made to verify that the correct label has been affixed to the container and the shield.....or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=17)

...This increases the likelihood for 6 administration of the wrong drug product by the 7 wrong.....If 20 embossing is to be continued, it should be done 21 where the drug name and dose is much larger.....area, fills 2 the container, and it withdraws, and then the 3 container is sealed and..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4040T1.DOC (score=16)

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 in a.....Container assemblies should be prepared at the beginning of the day before other daily.....Critical activities in the production and testing of a PET drug product that expose the PET drug product or the sterile surface..
http://www.fda.gov/cder/guidance/4259dft.htm (score=16)

FR Doc 04-4249
...For example, if an OTC drug manufacturer made and sold a particular drug product, that drug product would have a.....Alternatively, it may be possible to modify the drug's immediate container to accommodate a label bearing a.....For example, the physician may write a prescription for the right drug, but in the wrong dose. The pharmacist..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.htm (score=15)

Bar Code Label Requirements for Human Drug Products and Biological...
...For example, if an OTC drug manufacturer made and sold a particular drug product, that drug product would have a.....Alternatively, it may be possible to modify the drug's immediate container to accommodate a label bearing a.....For example, the physician may write a prescription for the right drug, but in the wrong dose. The pharmacist..
http://www.fda.gov/cber/rules/barcodelabel.htm (score=14)

Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products...
...A fixed-dose combination product is one in which two or more separate drug ingredients are combined in a.....product is to be packaged in a blister container, since polymer/foil blisters are not as impervious to moisture as high-density.....However, since some of the protease inhibitor regimens require the addition of low-dose ritonavir, a fourth drug..
http://www.fda.gov/oc/initiatives/hiv/hivguidance.html (score=13)

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