Final guidance intended to provide more clarity for drugmakers and safety-net providers participating in the federal 340B drug discount program is moving closer to release.

The White House Office of Management and Budget started its review Sept. 1 of the final guidance document (RIN:0906-AB08), according to the OMB's website. The Department of Health and Human Services released the proposed version of what it calls the omnibus guidance document in August 2015. The 340B program helps safety-net providers obtain discounted drugs.

The guidance would define who is considered a patient for purposes of the 340B program. The guidance also covers drug company responsibilities, such as procedures for issuing credits and refunds. Other subjects covered in the guidance are the HHS's audit of a covered entity, the HHS's audit of a manufacturer and a manufacturer's audit of a covered entity.

The drug industry generally supports the guidance because it says more clarity is needed for the 340B program, particularly for the definition of patient. However, safety-net providers have concerns with the guidance because they say it could limit their ability to serve the poor by putting additional restrictions on drug discounts.

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