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| FDA Proposes No ‘Pedigree’ for Unauthorized Rx Drug Distributors |
| 07/14/2011 |
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Federal Register Proposed rule: FDA is proposing to remove a section of the Prescription Drug Marketing Act (PDMA) regulations requiring that prior to completing any wholesale distribution of a prescription drug, an unauthorized distributor must provide to the purchaser a pedigree. FDA intends to exercise enforcement discretion on certain requirements of the PDMA while the rulemaking is pending as long as the pedigree identifies the names and addresses of the last authorized distributor of record that handled the drug. To view this proposed rule, click here. |
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