MedWatch: FDA's 'Heads Up' on Medical Product Safety
...So it is possible that a patient could have a serious reaction from a new drug when taken with another drug in a.....For example, a pharmacist may notice an off-color tablet in a drug container. A consumer may.....When the Food and Drug Administration approves drugs and other medical products, the..
http://www.fda.gov/fdac/features/1998/698_med.html (score=100)

Medwatch: From Test Tube to Patient: Improving Health Through Human Drugs
...Association of Chain Drug Stores.Partners help by inserting the.. nurse may notice a.....prompt the agency to require manu- drug container. A consumer may.. agency may require the.....assess the effects of every new drug..in combination with other approved.. roles in recent..
http://www.fda.gov/cder/about/whatwedo/testtube-8.pdf (score=100)

FINAL BROCHURE.qxp
...Report these events to the Food and Drug Administration at.. For additional government.....check for correct prescription therapy (drug container label.. - keep an extra supply of new.....container (thick plastic, leak-proof, capped container). - rash, hives.. to observe and..
http://www.fda.gov/cdrh/cdrhhhc/brochure-infusion.pdf (score=100)

Packaging
...If a medicine dropper is incorporated as an integral part of the drug container or closure.....If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier.....Samples of a drug that are selected for stability studies should be packaged in the container/clsoure system in which the drug..
http://www.fda.gov/cder/guidance/package.htm (score=63)

Fresh Air '2000' A look at FDA's Medical Gas Requirements
...Finally, a finished drug product odor test must be performed on each container undergoing.....Drug product containers and closures play a critical role in assuring that the drug.....This would pertain to any container or closure used to deliver industrial products, any..
http://www.fda.gov/cder/dmpq/freshair.htm (score=60)

...14927 15-Jun-00 EAGLE STAINLESS CONTAINER "EAGLE STAINLESS CONTAINER AS MFG IN WARMINSTER.....14821 07-Apr-00 SKC INC SKYROL PET FILMS FOR PACKAGING DRUG PRODUCTS AS MFG IN COVINGTON.....1539 17-Jun-70 ROBB CONTAINER PHARMACEUTICAL BOTTLES 1546 13-Aug-70 "WEST PHARMACEUTICAL..
http://www.fda.gov/cder/dmf/text/2Q2005ACTIVETYPE3TEXT.txt (score=58)

...14927 15-Jun-00 EAGLE STAINLESS CONTAINER "EAGLE STAINLESS CONTAINER AS MFG IN WARMINSTER.....14821 07-Apr-00 SKC INC SKYROL PET FILMS FOR PACKAGING DRUG PRODUCTS AS MFG IN COVINGTON.....1539 17-Jun-70 ROBB CONTAINER PHARMACEUTICAL BOTTLES 1546 13-Aug-70 "WEST PHARMACEUTICAL..
http://www.fda.gov/cder/dmf/text/3Q2004Type3ACTIVETEXT.txt (score=58)

Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the...
...discuss the proper use of needles and safe disposal in a sharps container (thick plastic.....check for correct prescription therapy (drug container label matches prescription) check all.....Report these events to the Food and Drug Administration at 1-800-332-1088 (24 hours) and..
http://www.fda.gov/cdrh/cdrhhhc/brochure-infusion.html (score=58)

Requirements for Submission of Labeling for Human Prescription Drugs and...
...drug and biologic industries, we assume labeling in paper, but have such labeling.....matter upon the immediate container of any article. VerDate jul<14>2003 .. 17:36 Dec 10.....Food and Drug Administration.. that FDA and the applicant agree upon, Regulatory..
http://www.fda.gov/cber/rules/labelelec.pdf (score=58)

...14927 III 15-Jun-00 EAGLE STAINLESS CONTAINER "EAGLE STAINLESS CONTAINER AS MFG IN.....14821 III 07-Apr-00 SKC INC SKYROL PET FILMS FOR PACKAGING DRUG PRODUCTS AS MFG IN.....1539 III 17-Jun-70 ROBB CONTAINER PHARMACEUTICAL BOTTLES 1546 III 13-Aug-70 "WEST..
http://www.fda.gov/cder/dmf/text/4Q2004TYPEIIIACTIVETEXT.txt (score=58)

Annex A Code of Federal Regulations (CFR)
...The term also includes repackaging or otherwise changing the container, wrapper, or labeling of any drug package to further the.....Registration of a drug establishment or drug wholesaler, or assignment of a registration number, or assignment.....First, the symbol appears prominently on the immediate container and on any outside container or wrapper and in a..
http://www.fda.gov/cder/drls/annexa.htm (score=58)

Document
...drug and biologic industries, we assume labeling in paper, but have such labeling.....matter upon the immediate container of any article. VerDate jul<14>2003 .. 17:36 Dec 10.....Food and Drug Administration.. that FDA and the applicant agree upon, Regulatory..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-30641.pdf (score=58)

...A device that serves as a container for a drug or a device that is a drug delivery system attached to the drug container where the.....Required if a drug or the chemical form of the drug has not been legally marketed in the United States as a human drug for.....container is a combination product that will be regulated as a drug by CDER. A device..
http://www.fda.gov/oc/ombudsman/drug-dev.htm (score=58)

MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....establish a set of criteria to which a drug substance or drug product should conform using.....elastomeric, plastic components or coatings of the container and closure system when in..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=21)

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...drug products can and has occurred as a result of entry through LDPE container closure.....packaged in semipermeable primary container closure systems, such as low-density.....adequate acceptance criteria to ensure that batches of drug products meet each appropriate..
http://www.fda.gov/cder/guidance/4168dft.pdf (score=21)

WAIS Document Retrieval
...FDA is proposing to limit the scope of the cut labeling provision to immediate container.....Background Persistent problems with drug product mislabeling and subsequent recalls in the.....If cut labeling is used for immediate container labels, individual unit cartons, or..
http://www.fda.gov/cder/dmpq/frpr7297.htm (score=21)

Guidance for Industry
...also require appropriate retesting of any component, drug product container, or closure that is subject.....In an aseptic process, the drug product, container, and closure are first subjected to.....The sterile drug product and container closures should be protected by equipment of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=21)

Guidance for Industry
...container and attached it to the container containing argon, and was able to fill the.....adverse drug experience, which is required to be reported to the Food and Drug.....oxygen container, installed it on the argon container, and connected the deadly product to..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=21)

Guidance for Industry
...also require appropriate retesting of any component, drug product container, or closure that is subject.....In an aseptic process, the drug product, container, and closure are first subjected to.....The sterile drug product and container closures should be protected by equipment of..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=20)

Format and Content for the CMC Section of an Annual Report
...Regulatory specifications and analytical methods for the drug substance and drug..product should be listed.....during the reporting period, including immediate container labels, carton..labeling, and.....container and closure system to the original system in accordance..with compendial..
http://www.fda.gov/cder/guidance/cmc1.pdf (score=20)

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