MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....An alternative approach may be used if such approach satisfies the requirements of the.....of each facility involved in the manufacturing of the drug substance and excipients should..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

GUIDE TO INSPECTIONS OF BULK PHARMACEUTICAL CHEMICALS
...Related substances are defined as those structurally related to a drug substance such as a degradation product or impurities.....a substance that is represented as a drug and, when used, becomes an active ingredient or finished dosage.....The USP also notes that the impurity profile of a drug substance is a description of the..
http://www.fda.gov/ora/inspect_ref/igs/bulk.html (score=94)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....its specification and, therefore, can be used in the manufacture of a given drug product.....Justification for an in-process test that is used in lieu of a drug substance test should..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=93)

Guidance for Industry: Human Somatic Cell Therapy and Gene Therapy
...Note that if drug substance (defined as bulk product not necessarily in final formulation)and.....Virus or DNA preparations used as preventive vaccines are not covered by this document.....abbreviate testing and IND submission for a product or product series, the sponsor should..
http://www.fda.gov/cber/gdlns/somgene.pdf (score=91)

Guidance- Content & Format CMC for Vaccine & Related Product
...A list should be provided of all components in the drug product, including drug substance(s)and other ingredients, with.....same areas used to produce the drug substance that is the subject of this application.....This section should contain information on the final drug product including all drug substances..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=90)

...When evaluating a bulk drug substance used to treat a less serious illness, FDA will generally be more.....To qualify for these statutory exemptions, a compounded drug product must satisfy several.....However, for a bulk drug substance used to treat a more serious or life-threatening disease, there may be..
http://www.fda.gov/ohrms/dockets/98fr/010799b.txt (score=90)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....its specification and, therefore, can be used in the manufacture of a given drug product.....Justification for an in-process test that is used in lieu of a drug substance test should..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=89)

WAIS Document Retrieval
...When evaluating a bulk drug substance used to treat a less serious illness, FDA will generally be more.....To qualify for these statutory exemptions, a compounded drug product must satisfy several.....However, for a bulk drug substance used to treat a more serious or life-threatening disease, there may be..
http://www.fda.gov/cder/fdama/pclist.txt (score=86)

Document
...351, 352, 353a, 355, nominated drug substances is limited, number and size of the bulk.....abstracts from reliable medical sources, substance has been used in pharmacy.. relevant.....through the new drug approval process, Academy of Compounding Pharmacists, rigorous and..
http://www.fda.gov/cder/fdama/pclist.pdf (score=84)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug Substance.....relation to the amount of crude product, whether it is filtered while hot, whether a.....Production of a drug substance, whether by synthesis, fermentation, or isolation, usually..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=82)

...A chemical constituent of a botanical raw material, drug substance, or drug product that is used for identification and/or quality.....These regulations require documentation of the drug substance, drug product, placebo, labeling, and an.....To ensure that a botanical drug product used in clinical trials is of consistently good quality, and..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=79)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale typically encountered.....and the test methods used to monitor the stability of the drug substance and preliminary.....and the test methods used to monitor the stability of the drug product packaged in the..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=76)

Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug...
...2 The term drug substance, which is used throughout the text, is intended to include biological products as defined.....specificity, avidity,microbiological safety), appropriate product comparability testing.....the potential impact on the biological safety, quality, and purity of the drug substance and/or..
http://www.fda.gov/cber/gdlns/mab032901.pdf (score=74)

Guidance for Industry: Developing Medical Imaging Drug and Biological...
...demonstrating whether the proposed drug product is safe for use under the conditions prescribed.....However, if a radioactive drug is used for immediate therapeutic, diagnostic, or similar purposes.....pharmacodynamic effects of a substance on physiologic functions in relation to exposure..
http://www.fda.gov/cber/gdlns/medimagesaf.pdf (score=71)

WAIS Document Retrieval
...Such studies should normally be conducted on the drug product or drug substance containing the degradation.....This guideline also does not address the regulation of drug products used during the clinical research.....Safety studies should provide a comparison of results of safety testing of the drug product or drug substance..
http://www.fda.gov/cder/guidance/ichq3b.htm (score=1)

Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls...
...If drug substance and drug product information is provided in an appendix, the preferred presentation is drug.....In some cases, data generated from testing samples of the reference listed drug can be used to support.....For solutions, the concentration of the drug substance in the drug product should be compared to the solubility of..
http://www.fda.gov/cber/gdlns/drugcmc.htm (score=1)

FDCAct Chapter II - Definitions
...substance used in food prior to January 1, 1958, through either scientific procedures or experience.....product of, or to have been packed or distributed by, such other drug manufacturer.....4) any substance used in accordance with a sanction or approval granted prior to the enactment of..
http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm (score=1)

GUIDE TO INSPECTIONS OF ORAL SOLID DOSAGE FORMS PRE/POST APPROVAL ISSUES...
...In either case it is important that the firm compare the drug substance used to manufacturer the bio.....Most companies have used product development reports, technology transfer reports, and others.....For example, micronizing or milling a drug substance and providing greater surface area of the..
http://www.fda.gov/ora/inspect_ref/igs/solid.html (score=1)

enforcement Policy for Section 503a pharmacy compounding
...exemptions, a compounded drug product must satisfy several requirements, some of which are.....substance to be under evaluation from the time it is nominated until FDA takes final.....risk, the Agency will provide notice that the substance cannot be used in compounding..prior to a final..
http://www.fda.gov/cder/guidance/2839dft.pdf (score=1)

Guidance for Industry: Analytical Procedures and Methods Validation...
...On request from FDA, an NDA or ANDA applicant must submit samples of drug product, drug substance.....For quantitation purposes, the response factor of the drug substance may be used for impurities without a.....For ANDAs and appropriate supplements, a sample of the finished product from a batch being used to support approval..
http://www.fda.gov/cber/gdlns/methval.htm (score=1)

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