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259 results
  1. NLM Digital Collections - Required warnings for cigarette packages and advertisements : small entity compliance guide ... 
    Publication: Silver Spring, MD : Center for Tobacco Products, July 2021
    resource.nlm.nih.gov/9918231297506676
    ... companies to continue to produce "soft pack" style packaging with closures at the top center of the pack without obstructing the required warning. However, if FDA determines that it would be ... on "soft pack" style packaging without the need to adapt the warning in ...
  2. NLM Digital Collections - Child-resistant packaging statements in drug product labeling 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
    resource.nlm.nih.gov/101760310
    ... patients. 14 See FDA guidance for industry Container Closure Systems for Packaging Human Drugs and Biologics, May 1999. This guidance ... products that are not subject to the special packaging requirements of 16 CFR 1700. 24 See 21 ... section of Module 3.2.P.7 Container Closure System (name, dosage form) in the eCTD. An ...
  3. NLM Digital Collections - Beikoku Kokuritsu Igaku Toshokan bunruihō : igaku oyobi kanren bun'ya ni okeru tosho haikahō 
    Publication: Tōkyō : Nihon Igaku Toshokan Kyōkai, 1996
    resource.nlm.nih.gov/9704321
    ... Combined Drug Compounding QV 778 Drug Containers and Closures see Drug Packaging Drug Contamination Fraud QV 773 Legislation and jurisprudence ... of Drugs) Ummc0X ikM QV 38$££ mmc^^M. (Packaging, Drug) l£H'1*tl£l$££ mmc^^-T^-bYk (Drug Containers and Closures) itmm &§£$££ ^Bc^StS (Incompatibility of Drugs) (£ge^m. ...
  4. NLM Digital Collections - National Library of Medicine classification : a scheme for the shelf arrangement of library ... 
    Publication: Bethesda, Md. : U.S. Dept. of Health and Human Services, Public Health Service, National Institutes of Health, National Library of Medicine ; Washington, D.C. : For sale by the Supt. of Docs., U.S. G.P.O., 1994
    resource.nlm.nih.gov/9440818
    ... Combined Drug Compounding QV 778 Drug Containers and Closures see Drug Packaging Drug Contamination Fraud QV 773 Legislation and jurisprudence ...
  5. NLM Digital Collections - National Library of Medicine classification : a scheme for the shelf arrangement of books in .... 
    Publication: Bethesda, Md. : U.S. Dept. of Health, Education, and Welfare, Public Health Service, National Institutes of Health, National Library of Medicine ; Washington : For sale by the Supt. of Docs., U.S. Govt. Print. Off., 1978
    resource.nlm.nih.gov/7900464
    ... prescribed Drug Compounding QV 778 Drug Containers and Closures see Drug Packaging QV 825 Drug Contamination Fraud QV 773 Legislation ...
  6. NLM Digital Collections - Chemistry, manufacturing, and control (CMC) information for human gene therapy ... 
    Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
    resource.nlm.nih.gov/101767656
    ... systems, refer to FDA’s Guidance for Industry: “Container Closure Systems for Packaging Human Drugs and Biologics” (Ref. 25). 41 Contains ... media/71722/download. 25. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics, May 1999. https://www. ...
  7. NLM Digital Collections - Premarket tobacco product applications for electronic nicotine delivery systems 
    Publication: Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, June 2019
    resource.nlm.nih.gov/101760254
    ... regarding the product’s container closure system. The container closure system refers to any packaging materials that are a component or part of ... or characteristics of a tobacco product. The container closure system could, for ... from the packaging into the product, as has previously occurred with ...
  8. NLM Digital Collections - COVID-19 container closure system and component changes : glass vials and stoppers 
    Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, March 2021
    resource.nlm.nih.gov/9918332784506676
    ... as discussed in the guidance for industry Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls ... Application: Certain Biological Products (December 2017) 25 • ... for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls ...
  9. NLM Digital Collections - Mixing, diluting, or repackaging biological products outside the scope of an approved ... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
    resource.nlm.nih.gov/101720078
    ... repackaged, whichever is shorter; or 16 A container-closure system is the sum of packaging components that together contain and protect the dosage ... conducts either a sterility test or a container closure integrity test o See USP ... Evaluation) at additional time points. 4. Shipping ...
  10. NLM Digital Collections - Best practices in developing proprietary names for human prescription drug products 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
    resource.nlm.nih.gov/9918249609906676
    ... added 40 protection to the drug product. A packaging system is equivalent to a container closure system. 41 42 End user: The term end ... any supplement to any of them.” 95 96 Packaging: A package or market package refers to the container closure system and labeling, 97 associated components (e.g., ...
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