340B covered entities may elect to dispense 340B drugs to patients through contract pharmacy services, an arrangement in which the 340B covered entity signs a written contract with a pharmacy to provide pharmacy services. For more information about contact pharmacy arrangements, including how to register a contract pharmacy, visit the HRSA OPA website.
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Other FAQ CategoriesThe covered entity must also terminate the contract pharmacy relationship established under the previous owners. To effectuate the termination, complete an online termination request. Failure to report a change in ownership may result in a lapse in 340B access through the specific contract pharmacy.
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If the covered entity determines that drug diversion or duplicate discounts occurred or that it is otherwise unable to comply with its responsibility to reasonably ensure compliance, the covered entity can you use this Self Disclosure tool to disclose the violation to HRSA https://www.340bpvp.com/Documents/Public/340B%20Tools/self-disclosure-to-hrsa-and-manufacturer-template.docx . This information should be mailed to: Health Resources and Services Administration, Office of Pharmacy Affairs, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857.
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In addition, and as a best practice, the contract pharmacy provides the covered entity with reports consistent with customary business practices (e.g. quarterly billing statements, status report of collections and receiving and dispensing records). The contract pharmacy, with the assistance of the covered entity, establish and maintain a tracking system suitable to prevent diversion of 340B drugs and duplicate discounts on the drugs. The contract pharmacy assures that all pertinent reimbursement accounts and dispensing records, maintained by the pharmacy, will be accessible separately from the pharmacy’s own operations and will be made available to the covered entity, HRSA, and the manufacturer in the case of an audit.
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(1) the covered entity retains ownership and title to the 340B drugs;
(2) the covered entity will not sell its 340B drugs or otherwise transfer ownership to the repackager; and (3) the . The covered entity is not required to register the repackager as a contract pharmacy so long as:
(1) the covered entity retains ownership and title to the 340B drugs;
(2) the covered entity will not sell its 340B drugs or otherwise transfer ownership to the repackager; and (3) the repackager will not dispense 340B drugs.
Based on those specific circumstances, and the fact that the repackager is not a pharmacy and will not dispense drugs, OPA does not require the repackager to register as a contract pharmacy.
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1) are dated prior to the registration period;
2) include a list of all applicable covered entity locations identified by name and address identical to 340B OPAIS records or provide an all-inclusive statement identifying all parent an. HRSA ensures that contract pharmacy agreements:
1) are dated prior to the registration period;
2) include a list of all applicable covered entity locations identified by name and address identical to 340B OPAIS records or provide an all-inclusive statement identifying all parent and child/associated sites actively listed in 340B OPAIS;
3) include a list of all pharmacy locations identified by name and address which should identically match those submitted for registration; and
4) include signatures of officials from both the entity and the pharmacy.
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