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Guidance for Industry - Pharmanet

X:\CDERGUID\ for IndustrySkin Irritation and SensitizationTesting of GenericTransdermal Drug ProductsDRAFT GUIDANCEThis Guidance document is being distributed for comment purposes and suggestions regarding this draft document should be submitted within 60 days ofpublication of the Federal Register notice announcing the availability of the draft Guidance . Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration,5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with thedocket number listed in the notice of availability that publishes in the Federal questions on the content of the draft document contact Mary Fanning, 301-827-5845.

X:\CDERGUID\2887DFT.WPD 2/5/99 Guidance for Industry Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.

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Pharmaceutical Blister Packaging, Part I

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States is troubling. Pharmacists or phar-maceutical technicians count pills in the uncontrolled atmosphere of the super-market and drug store, where many fac-tors can negatively affect sensitive drugs as they are transferred from container to container. Blister packaging helps retain product integrity because drugs that are pre-

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