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ACCUTANE (ISOTRETINOIN) CAPSULES: PRECAUTIONS FOR WHOLESALERS

Accutane must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Accutane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE. Registered and activated pharmacies must receive Accutane only from wholesalers registered with iPLEDGE.

iPLEDGE program requirements for wholesalers, prescribers, and pharmacists are described below:

Wholesalers

For the purpose of the iPLEDGE program, the term wholesaler refers to wholesaler, distributor, and/or chain pharmacy distributor. To distribute Accutane, wholesalers must be registered with iPLEDGE, and agree to meet all iPLEDGE requirements for wholesale distribution of isotretinoin products. Wholesalers must register with iPLEDGE by signing and returning the iPLEDGE wholesaler agreement that affirms they will comply with all iPLEDGE requirements for distribution of isotretinoin. These include:

  • Registering prior to distributing Isotretinoin (Accutane) capsules and re-registering annually thereafter
  • Distributing only FDA approved isotretinoin product
  • Only shipping isotretinoin to

    - wholesalers registered in the iPLEDGE program with prior written consent from the manufacturer or
    - pharmacies licensed in the US and registered and activated in the iPLEDGE program

  • Notifying the isotretinoin manufacturer (or delegate) of any non-registered and/or non-activated pharmacy or unregistered wholesaler that attempts to order isotretinoin
  • Complying with inspection of wholesaler records for verification of compliance with the iPLEDGE program by the isotretinoin manufacturer (or delegate)
  • Returning to the manufacturer (or delegate) any undistributed product if registration is revoked by the manufacturer or if the wholesaler chooses to not re-register annually
  • Providing product flow data to manufacturer (or delegate) as detailed in the wholesalers agreement

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