Sec. 253. Changes to Federal opioid treatment standards
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Section 302(e) of the Controlled Substances Act ( 21 U.S.C. 822(e) ) is amended by adding at the end the following: Notwithstanding paragraph (1), a registrant that is dispensing pursuant to section 303(g) narcotic drugs to individuals for maintenance treatment or detoxification treatment shall not be required to have a separate registration to incorporate one or more mobile medication units into the registrant’s practice to dispense such narcotics at locations other than the registrant’s principal place of business or professional practice described in paragraph (1), so long as the registrant meets such standards for operation of a mobile medication unit as the Attorney General may establish. .
Not later than two years after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate a final regulation amending paragraphs (i)(3)(i) through (i)(3)(vi) of section 8.12 of title 42, Code of Federal Regulations, as appropriate based on the findings of the study under section 252 of this Act. The regulation under paragraph
(1)shall establish relevant criteria for the medical director of an opioid treatment program, or a medical practitioner appropriately licensed by the State to prescribe or dispense controlled medications, to determine whether a patient is stable and may qualify for unsupervised use, which criteria shall include each of the following: Whether the benefits of providing unsupervised doses to a patient outweigh the risks. The patient’s demonstrated adherence to their treatment plan. The patient’s history of negative toxicology tests. Whether there is an absence of serious behavioral problems. The patient’s stability in living arrangements and social relationships. Whether there is an absence of substance misuse-related behaviors. Whether there is an absence of recent diversion activity. Whether there is an assurance that the medication can be safely stored by the patient. Any other criterion the Secretary of Health and Human Services determines appropriate. The regulation under paragraph
(1)shall prohibit the medical director of an opioid treatment program from considering, as the sole consideration in determining whether a patient is sufficiently responsible in handling opioid drugs for unsupervised use, whether the patient has an absence of recent misuse of drugs (whether narcotic or nonnarcotic), including alcohol.