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      REMS and iPledge Requirements

      Some medications available on Pharmacy Marketplace fall under REMS (Risk Evaluation and Mitigation Strategy) programs, including the iPLEDGE program, which is required by the FDA to ensure safe use of certain high-risk drugs.

      What Are REMS Programs?

      REMS programs are FDA-mandated safety strategies for certain medications with serious safety concerns. These may include:

      • iPLEDGE (for isotretinoin and generics)

      • Clozapine REMS

      • REMS for opioid analgesics

      • REMS for mifepristone, and others

      Each REMS program has specific requirements that must be fulfilled before a pharmacy can purchase or dispense the product.

      Does Pharmacy Marketplace Handle REMS or iPLEDGE Registration?

      No. Pharmacy Marketplace does not directly manage REMS or iPLEDGE validations.
      Instead, each individual wholesaler that lists REMS-restricted items on the platform is responsible for validating your pharmacy’s compliance before allowing you to purchase those items.

      This means:

      • You must be enrolled and in good standing with the relevant REMS program (e.g., iPLEDGE) through your pharmacy’s DEA/NABP number.

      • You must ensure that your REMS status is correctly reflected and approved with each wholesaler from which you intend to purchase a restricted item.

      How Does This Work on Our Platform?

      If you see a REMS item listed on Pharmacy Marketplace:

      1. You may see pricing and availability, but you will only be able to purchase the product if:

        • The wholesaler carrying that product has validated your pharmacy’s REMS status

        • All REMS-related documentation is up to date with that wholesaler

      2. If you're not approved, your order may be held or canceled until validation is complete.

      3. Some wholesalers require a separate onboarding process to validate REMS participation, even if you're already approved by a different wholesaler.

      What Should You Do If You're Blocked from Purchasing a REMS Product?

      • Contact the wholesaler directly (contact information is available at the bottom of the Settings page) to confirm your REMS approval status with them.

      • If you're unsure which wholesaler to contact, reach out to our team (support@pharmacymarketplace.com); we're happy to point you in the right direction.

      Important Notes

      • REMS validation is wholesaler-specific: Approval with one wholesaler does not guarantee approval with others.

      • Pharmacy Marketplace cannot override a wholesaler’s decision or submit REMS forms on your behalf.

      Need Help?

      If you have questions about a specific product or want assistance identifying the appropriate wholesaler contact, please don’t hesitate to reach out to us at: support@pharmacymarketplace.com