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Federal Guidelines on Opioid Treatment Programs

The attached document from the Federal Government on Opioid Treatment Programs (OTP) lays out a number of guidelines that all providers and licensing agencies must follow:

As stated in 42 CFR § 8.12(i)(2), these regulations apply to “opioid agonist treatment medications that are approved by the Food and Drug Administration.” Currently, these drugs are methadone and pharmaceutical products containing buprenorphine, hereafter referred to as buprenorphine. 

There are a couple of interesting points.  One is that the safety of the public is specifically noted:

They are not intended to provide clinical or medical guidelines but rather to assure, to the greatest extent possible, the safety of both the patient and the public.

Also note that we should be able to obtain ‘critical incident’ reports as all providers are expected to give them to: 

the appropriate federal and state agencies and others according to the program’s procedures and any applicable regulatory and accrediting organization requirements.


These events may include accidental injury or violence on the premises; medication errors; harm to family members or others from ingesting a patient’s medication; selling drugs on the premises; medication diversion; harassment or abuse of patients by staff; unexpected or suspicious deaths; deaths related to overdose or medication interactions; or any other injury or death that raises individual, family, community, or public concern.

However, most importantly there are guidelines on page 18 that specifically state that:

Before a new OTP moves into a community or neighborhood and opens its doors to patients, there is a strong need to educate all entities affected by the program’s presence, including the medical community, neighbors, and those who provide support services. States may have specific community relations plan requirements for opening or moving an OTP into a community or neighborhood.

OTPs must have policies and procedures to measure and minimize the negative impact an existing or new program may have on a community, promote peaceful coexistence, and plan for change and program growth.  Such policies and procedures should address:

  • Community need and impact when selecting sites for programs.
  • Community input on the potential impact a program may have on a neighborhood

I encourage you to look at the document carefully and pages 18/19 in particular. 

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