SAMHSA's Form SMA-162: What Goes in Each Part of the Packet

Form SMA-162 is SAMHSA's application for opioid treatment program (OTP) certification. Part 8 names it in its list of forms as the "Application for Certification to Use Medications for Opioid Use Disorder" (42 CFR 8.15(a)); several SAMHSA web pages still use the older title, "Application for Certification to Use Opioid Drugs in a Treatment Program." Either way it is the same online form, filed through the SAMHSA OTP Extranet, and an OTP will file it many times over its life, not just once at the start.

When does an OTP file an SMA-162?

• Provisional certification for a new program, with the Provisional Certification box checked (SAMHSA OTP FAQs).
• Renewal of certification, applied for in the final year of the certification period (42 CFR 8.11(a)(4)).
• Re-certification after certification has expired. The program is treated as new, and the application must explain why the last certification expired and give the schedule for an accreditation survey (8.11(a)(6), (b)(8)).
• Relocation of the primary dispensing site or of a medication unit, which needs SAMHSA approval.
• A new medication unit, mobile or brick and mortar, which needs SAMHSA approval before it opens (8.11(h)(1)).
• A new program sponsor or medical director, reported within three weeks (8.11(e)(5)).

SAMHSA's "Notify SAMHSA of Program Changes" page adds a rule that trips up busy programs: "A separate Form 162 is required for each change. OTPs may not submit multiple changes on one form." A change of ownership, a program name change and a closure are different again: those go to SAMHSA's Division of Pharmacologic Therapies by email or to the state's SAMHSA compliance officer, not on the form.

What does the rule say every application must contain?

For an initial or renewal application, 42 CFR 8.11(b) lists the core content:

1. A description of the program's current accreditation status.
2. A description of its organizational structure.
3. The names of the persons responsible for the OTP.
4. The addresses of the OTP and of each medication unit or other facility under its control.
5. Its sources of funding, with the name and address of each governmental entity that funds it.
6. A statement that the OTP will comply with the conditions of certification.
7. The program sponsor's signature, certifying "that the information submitted in the application is truthful and accurate."

A new program asking for provisional certification adds a statement naming the accreditation body it has applied to, the date it applied, the dates of any surveys held or scheduled, and the expected schedule for finishing accreditation (8.11(d)). That is why the accreditation application has to go in first.

Which supporting documents does SAMHSA list for a new program?

SAMHSA's "Become an OTP" page lists what a new applicant should prepare and upload with the form (as text, TIFF, PDF or Word files):

• The accreditation details: the date you applied, any previous or scheduled survey dates, and the expected schedule for completing accreditation.
• An organizational description and chart naming key OTP personnel by position and title, plus the name and full address of any central administration or parent organization.
• A facilities description and diagram showing the space is adequate for dispensing and for individual and group counseling, and how the OTP will provide medical, counseling, vocational, educational and assessment services at the primary facility, unless the sponsor has a formal documented agreement with another entity.
• Outside facilities: the name, address and description of each hospital, institution, clinical laboratory or other facility the OTP uses, and of any site other than the primary dispensing site where methadone will be dispensed.
• The medical director's file: DEA registration, state license and curriculum vitae. If the medical director also directs another treatment program, a written justification of how that arrangement is feasible.
• Licensed dispensing staff: the name and state license number of every person other than program physicians licensed to dispense narcotic drugs, such as pharmacists, registered nurses and licensed practical nurses, even if they are not dispensing now.
• A tentative schedule of dispensing hours, counseling hours and physician, nurse and counselor hours. SAMHSA states: "The program must be open for dispensing at least six days per week."
• Funding sources, with each governmental funder's name and address.
• Capacity: the number of patients to be treated at operating capacity.
• A safety-closure statement that take-home medication will be dispensed in containers with safety closures.
• An Extranet acknowledgment that the medical director or a program physician must register for an OTP Extranet account to submit patient exception requests on Form SMA-168.

Do relocation and medication unit filings need more?

For a relocation, SAMHSA asks for "a detailed labeled floor diagram for all areas of the building," with the dispensing windows, the medical director's office, nurses' stations, counselors' offices and the individual and group counseling space marked, plus a written description showing the facility is adequate. The FAQ is firm that a program should not try to change its address through a renewal application; a relocation gets its own SMA-162.

For a new medication unit, SAMHSA lists a justification of the need for the unit, how it receives its medication supply, a labeled floor diagram, a facility description, patient counts for the primary facility and the unit, any existing units, and affirmative statements, including that "the sponsor agrees to retain responsibility for patient care." One of those listed statements says the unit is limited to dispensing and collecting samples for drug testing, which is narrower than the 2024 rule, under which "any services that are provided in an OTP may be provided in the medication unit" where space and privacy allow (8.11(h)(2)). Ask your compliance officer which statement SAMHSA wants before you file. Our post on adding a medication unit covers the DEA and state side.

For a new medical director, SAMHSA wants the director's DEA registration, state license and CV, and a statement that the director will work only at this facility, or a justification of the arrangement if not. See changing program sponsor or medical director.

Who may sign and submit it?

Only the program sponsor. SAMHSA's program-changes page says so in as many words: "Only an OTP program sponsor may sign and submit a Form SMA-162." After the form is submitted, SAMHSA emails the sponsor a link, and "the sponsor will need to electronically sign the form to complete the submission process." SAMHSA also says existing sponsors "should have an individual SAMHSA OTP Extranet account."

The program sponsor is defined in Part 8 as the person named in the application as responsible for the operation of the OTP, who "assumes responsibility for all its employees," including at medication units. The sponsor need not be a physician but must make sure a licensed physician is the medical director (42 CFR 8.2). A consultant can draft every attachment. The sponsor reviews, signs and submits from the sponsor's own account, and that is how it should be.

Why do SMA-162 packets come back?

1. No accreditation application yet. Provisional certification is only for a program that has already applied to an accrediting body, and the packet must say which one and when.
2. A diagram that does not show the dispensing and counseling space. Both SAMHSA and DEA look for it; DEA requires the waiting area to be physically separated from narcotic storage and dispensing (21 CFR 1301.74(j)).
3. A medical director without current DEA registration or state license on file.
4. A schedule with fewer than six dispensing days.
5. Several changes on one form, or an address change slipped into a renewal.
6. A missing full survey report at renewal. SAMHSA's FAQ says a renewal stays "in processing" until the OTP submits a copy of the full accreditation survey report, and asks programs not to file a duplicate SMA-162 while it waits.

How long will SAMHSA take?

For a new program, SAMHSA "requests 45 days from the receipt of the provisional application to render a decision," and it will not grant provisional certification without state and DEA approvals. Incomplete applications take longer. Plan the state license and the DEA Form 363 alongside the SMA-162, not after it. The full order is in opening an opioid treatment program.

Can we prepare the packet?

Yes. SMA-162 drafting is part of our Opioid Treatment Program Approval Package ($6,995 plus the state license package): the facility description and diagram narrative, the organizational chart, the staffing and dispensing schedule, the funding and capacity statements and the medical director's file, cross-checked against the state and DEA filings. Later SMA-162s are separate flat fees: an OTP Medication Unit is $1,495, OTP SAMHSA Certification Renewal is $595, and an Ownership Change or Relocation is $795. Your sponsor reviews, signs and submits every form from the sponsor's own Extranet account; we never hold it. See pricing or the OTP approval hub.