they comply with FDA repackaging regulations regarding the provision of stock, deem that bidder and therefore ineligible to receive an award? (4) If the answer to part (3) ( immediately preceding) is what process will DGS follow prior to awarding a “no,” contract to ensure compliance with federal and state laws regarding stock repackaging so that DGS does not award a contract to a vendor, only for the DGS to later discover that the vendor is unable to comply, which would place your facilities at risk for possible fines and/or disciplinary actions upon inspection? 28 General The FDA-registered repackager requirement appears to (1) The selected Offeror, in the performance of all of the requirements of any 6 Question have been removed from the RFP. However, all of the contract resulting from this RFP, must comply with all applicable federal, state, following remain true: and local laws and regulations as set forth in Part III-1.J(1). By submitting a proposal in response to this RFP, Offerors represent to the Commonwealth that All legend stock medications are required to be sent by they, and any subcontracts to be used in performance of the Contract, are • a licensed wholesaler, according to the Wholesale compliant with the applicable federal, state, and local laws and regulations. See Prescription Drug Distributors License Act (Act No. Part I-24.A. If at any point during the contract term, a change in status or scope 1992-145, H.B. No. 2602). requires a change in licensure/registration status in order to remain compliant A transaction history document (formerly called a with all applicable federal, state, and local laws and regulations, it is the • is required for wholesale transactions, responsibility of the selected Offeror to ensure that the new requirements are “pedigree”) according to the federal Drug Quality and Security Act met immediately and must notify the PADOC within 10 calendar days of such a (DQSA). required change. A transaction history document (formerly called a • cannot be broken down further than the (2) The RFP language remains as stated. “pedigree”) original manufacturer’s package size. (1) As the above are true for a vendor to comply with federal and state laws, is the PADOC’s intent to obtain all stock medication in original manufacturers’ bottles
they comply with FDA repackaging regulations regarding the provision of stock, deem that bidder and therefore ineligible to receive an award? (4) If the answer to part (3) ( immediately preceding) is “no,” what process will DGS follow prior to awarding a contract to ensure compliance with federal and state laws regarding stock repackaging so that DGS does not award a contract to a vendor, only for the DGS to later discover that the vendor is unable to comply, which would place your facilities at risk for possible fines and/or disciplinary actions upon inspection? 28 General Question The FDA-registered repackager requirement appears to have been removed from the RFP. However, all of the following remain true: • All legend stock medications are required to be sent by a licensed wholesaler, according to the Wholesale Prescription Drug Distributors License Act (Act No. 1992-145, H.B. No. 2602). • A transaction history document (formerly called a “pedigree”) is required for wholesale transactions, according to the federal Drug Quality and Security Act (DQSA). • A transaction history document (formerly called a “pedigree”) cannot be broken down further than the original manufacturer’s package size. (1) As the above are true for a vendor to comply with federal and state laws, is the PADOC’s intent to obtain all stock medication in original manufacturers’ bottles (1) The selected Offeror, in the performance of all of the requirements of any contract resulting from this RFP, must comply with all applicable federal, state, and local laws and regulations as set forth in Part III-1.J(1). By submitting a proposal in response to this RFP, Offerors represent to the Commonwealth that they, and any subcontracts to be used in performance of the Contract, are compliant with the applicable federal, state, and local laws and regulations. See Part I-24.A. If at any point during the contract term, a change in status or scope requires a change in licensure/registration status in order to remain compliant with all applicable federal, state, and local laws and regulations, it is the responsibility of the selected Offeror to ensure that the new requirements are met immediately and must notify the PADOC within 10 calendar days of such a required change. (2) The RFP language remains as stated. 6
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