New Mexico Register / Volume XXXVII,
Issue 6 / March 24, 2026
NOTICE
OF PUBLIC HEARING
The
New Mexico Department of Health will hold a public hearing on the proposed adoption
of a new rule, 7.35.2 NMAC, concerning the New Mexico Medical Psilocybin
Program (“Program”). The hearing will be
held on Friday, April 24, 2026 at 9:00 a.m. in the
Harold Runnels Building auditorium, located at 1190 St. Francis Drive, Santa
Fe, New Mexico. The hearing will also be
broadcast via a live web-based video conference, and via telephone. Members of
the public who wish to submit public comment regarding the proposed rule will
be able to do so in person at the hearing, via video conference, or via
telephone during the course of the hearing, and by submitting written comment.
The rule 7.35.2
NMAC proposes to adopt standards for psilocybin producers and psilocybin
testing laboratories in the NM Medical Psilocybin Program. The rule includes, but is not limited to, the
following:
* Section 7, “Definitions”: defines various
terms used in the rule;
* Section 8, “Permit Application Requirements”:
sets requirements for applications for producer and laboratory permits;
* Section 9, “General Permittee Requirements”:
sets requirements applicable to all producers and laboratories in the Program,
including restrictions on transfer of permits and control and a prohibition on
nominee, straw, and proxy ownership;
* Section 10, “General Producer Requirements”:
sets general requirements particular to producers in the Program;
* Section 11, “Allowed Psilocybin Products”:
prohibits adulteration of psilocybin products and requires homogenization of
psilocybin products;
* Section 12, “Pesticides and Other Adulterants
Prohibited”: prohibits application of pesticides to fungi or growing medium;
* Section 13, “Producer Policies and
Procedures”: requires producers to create and maintain various policies and
procedures concerning the production process and product waste;
* Section 14, “Packaging and Labeling; Product
Information Document”: sets standards for labeling of medical psilocybin
products and creation of an associated product information document;
* Section 15, “General Tracking Requirements”:
requires tracking of batches and lots, and wasting of psilocybin material,
using the Department’s identified traceability system;
* Section 16, “Implementation and
Administration of Traceability System”: requires designation of users of the
Department-identified traceability system, training of users, and continuing
education;
* Section 17, “General Traceability System
Use”: requires maintaining an accurate user list, and cancellation of user
accounts for users who are no longer employed by the producer;
* Section 18, “Compliance Notifications”:
requires that producers and laboratories monitor compliance notifications and
informational notifications in the traceability system;
* Section 19, “Required Testing of Psilocybin
Products”: sets standards for laboratory testing of psilocybin products for
microbiological contaminants, water content, potency, heavy metals, and
pesticides.
* Section 20, “Additional Testing Services
Offered by Psilocybin Testing Laboratories”: authorizes additional psilocybin
testing for purposes of quality improvement, research and development, and
labeling;
* Section 21, “Wastage of Psilocybin and
Psilocybin Products; Permitted Methods”: requires that any psilocybin product
to which a pesticide has been applied be converted to waste;
* Section 22, “Quality Assurance Testing;
Complaint Procedure”: authorizes QA testing by the Department of Health, and
describes how complaints can be submitted;
* Section 23, “Producer Requirements for
Sanitation and Product Handling”: incorporates various provisions of the 2022
FDA Model Food Code;
* Section 24, “Requirements for the
Transportation of Psilocybin”: sets requirements for transport of psilocybin
products;
* Section 25, “Monitoring and Corrective
Actions”: authorizes the Department to perform on-site assessments of a
permittee or permit applicant, interview persons affiliated with permittees;
and
* Section 26, “Disciplinary Actions and Appeals
Process”: establishes procedures for disciplinary actions against permit
holders and applicants for a permit, including grounds for disciplinary
actions, and the process for requested administrative hearings.
The purpose of the
proposed rule 7.35.2 NMAC is to implement the Medical Psilocybin Act, sections 26-2D-1
through -11, NMSA 1978.
The legal
authority authorizing the adoption of this rule by the Department is the
Department of Health Act, subsection E of section 9-7-6 NMSA 1978, which
authorizes the secretary of the department of health to “...make and adopt such
reasonable and procedural rules and regulations as may be necessary to carry
out the duties of the department and its divisions,”; and the Medical
Psilocybin Act, at section 26-2D-7, NMSA 1978, which requires the Department to
promulgate requirements, restrictions, and limitations for the Program, as well
as necessary training, safety protocols, best practices, and requirements for
data collection.
A free copy of
the full text of the proposed rule can be obtained online from the New Mexico
Department of Health’s website at http://nmhealth.org/about/asd/cmo/rules/ or
by contacting the Department using the contact information below.
The public hearing will be conducted to receive public
comment on the proposed rule. Any
interested member of the public may attend the hearing and may submit data,
views, or arguments on the proposed rule either orally or in writing during the
hearing.
The hearing will be held on April 24, 2026 at the Harold Runnels Building auditorium, located at
1190 St. Francis Drive, Santa Fe, New Mexico.
To access the hearing via the Internet: please go to
https://www.microsoft.com/en-us/microsoft-teams/join-a-meeting and then enter
the following meeting i.d. code and passcode where
indicated on the screen: meeting i.d. code 228 537
544 934 10 and passcode tL3eH7yM and then
click the “Join a meeting” button.
To access the hearing by telephone: please call 1-505-312-4308
and enter phone conference i.d. 467 689 840#
All comments will be recorded.
Written public
comment regarding the proposed rule can be submitted either by e-mail to Jacob
Clark at jacob.clark@doh.nm.gov, or by U.S. postal mail to the following
address:
Jacob Clark
NMDOH OGC
P.O. Box 26110
1190 St. Francis Dr., Suite N-4095
Santa Fe, NM
87502-6110
Written
comments must be received by the close of the public rule hearing on April 24,
2026. All written comments will be
published on the agency website at https://www.nmhealth.org/about/asd/cmo/rules/
within 3 days of receipt, and will be available at the New Mexico Department of
Health for public inspection.
If you are an
individual with a disability and need special assistance or accommodation to
attend or participate in the hearing, please contact Jacob Clark by telephone
at (505) 827-2997. The Department
requests at least ten (10) days’ advance notice to provide special
accommodation.