We especially commend HHS for recognizing that certain types of buprenorphine products should be treated differently under the buprenorphine patient limit because they inherently minimize the risk of diversion and ensure patient compliance. Braeburn’s comments in response to Question 2 in the proposed rule will recommend that patients treated with buprenorphine drug products labeled for direct administration by highly-qualified addiction treatment providers should not count toward the DATA 2000 prescriber patient limit.
If they are successful and the Final Rule includes such an exemption, there would be in effect no limitation to probuphine prescriptions.