HHS Proposes Increasing Buprenorphine Patient Limit for Medication-Assisted Treatment.
With the goal of expanding access to medication-assisted treatment (MAT), United States Department of Health and Human Services (HHS) has proposed a rule that would permit qualified physicians to prescribe buprenorphine, the opioid use disorder treatment medication, to as many as 200 patients. Under current regulations, physicians who are certified to prescribe buprenorphine for MAT can only prescribe up to 30 patients initially and after one year can request authorization to prescribe up to a maximum of 100 patients. Substance Abuse and Mental Health Services Administration Principal Deputy Administrator Kana Enomoto states “there are long patient waiting lists for prescribers who have reached the 100 patient limit.”
Buprenorphine is a Food and Drug Administration (FDA)-approved drug used as part of MAT, a comprehensive way to address the recovery needs of individuals that combines the use of medication with counseling and behavioral therapies to treat substance use disorders, indicates the HHS press release. HHS Secretary Sylvia Burwell said the proposal “is critical in our comprehensive approach to addressing the serious opioid epidemic facing our nation.” More information about MAT and increasing the patient limit is available in the HHS fact sheet.
Written or electronic comments on the proposed rule must be submitted by May 31, 2016. The Federal Register notice contains instructions and additional information for submitting public comment.
Drug Enforcement Administration (DEA) has published its final rule rescheduling hydrocodone combination products from Schedule III to Schedule II in the Federal Register. The change imposes Schedule II regulatory controls and sanctions on anyone handling hydrocodone combination products, effective October 6, 2014.
DEA first published the proposed rules in March 2014, in response to a Food and Drug Administration recommendation.
DEA received almost 600 public comments regarding the proposed rules after they were published, with a small majority of the commenters supporting the change, a DEA press release notes.
Plan B One-Step, an emergency contraceptive, has been approved for unrestricted sales by the FDA after months of back-and-forth political battles between the Obama administration and federal courts. The morning-after pill is finally going over-the-counter. The Food and Drug Administration on Thursday approved unrestricted sales of Plan B One-Step, lifting all age limits on the emergency contraceptive.
Under a final rule (PDF) published in the Federal Register, the pain reliever tramadol is now classified as a Schedule IV controlled substance (CS). Starting August 18, 2014, Drug Enforcement Administration (DEA) will require manufacturers to print the "C-IV" designation on all labels that contain 2- [(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol (tramadol), including its salts, isomers, and salts of isomers.
The agency notes that every "DEA registrant who possesses any quantity of tramadol on the effective date of this final rule must take an inventory of all stocks of tramadol on hand as of August 18, 2014, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03,1304.04, and 1304.11 (a) and (d)." In addition, all "prescriptions for tramadol or products containing tramadol must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR part 1306 and subpart C of 21 CFR part 1311 as of August 18, 2014."
br /> National Association of State Controlled Substances Authorities notes (PDF) that several states have already classified tramadol as a CS. To "provide a reasonable time for registrants to comply with the handling requirements" for a Schedule IV CS, DEA established the effective date of the final rule as 45 days from the date of publication.