For producers

Before you apply

What the rule says an applicant provides with the application and keeps current afterward. Each is a document, not a promise; having them in hand before the application is what saves the time. Where each comes from, agency by agency, is on pathways.medical-psilocybin.org.

The traceability account, its administrator, and the department's system training come after the permit issues, but the account must be live before operating, and every cost of the system, vendor fees included, falls on the permittee. 7.35.2.16, p. 8

The rule states no application form, fee, filing address, review timeline, permit term, or renewal. The word "fee" appears once, for traceability vendor fees. The department's program page, as read on September 7, 2026, posts no application.

1. The permit application

An applicant for a producer permit provides, and then maintains, twelve records: a New Mexico business license; registration with the secretary of state; registration with the taxation and revenue department; a certificate of occupancy; proof of fire code compliance; electrical and HVAC inspection reports; proof of compliance with city and county planning and zoning; proof that the facility is inside New Mexico; proof of ownership of the facility, or a signed, written statement from the property owner acknowledging that the tenant will be participating in the program as a permittee and what the permit allows; conditional use permits where applicable; an attestation that all psilocybin will be produced only within New Mexico and not transported beyond its borders; and any further documentation the department reasonably requests. 7.35.2.8 (A), p. 4

A producer applicant additionally provides and maintains food safety training certificates for employees. 7.35.2.8 (B), p. 4

A permittee applies for and obtains an amended permit before any substantial structural modification of the permitted location, and notifies the department of any change to registrations, licenses, permits, certifications, and of equipment alterations or acquisitions that substantially affect the production process. 7.35.2.8 (D), p. 5

2. Ownership and control

A person holding an ownership interest in one permittee may not hold an ownership interest in any other. A permit is not transferable by sale, assignment, or otherwise, except as the department approves on the death of a sole proprietor; a transferred permit is invalid. Actual control may not be transferred by a management, consulting, or intellectual property agreement or by any other means, and a transfer of actual control invalidates the permit. Nominee, straw, and proxy ownership are prohibited. 7.35.2.9 (B) through (E), p. 5

A permittee keeps a complete list of every individual and legal entity holding a financial interest in it or its operations, with contact information and a description of the interest, and produces it within 15 calendar days of the department's written request. For a legal entity holding an interest, each general partner, each manager and managing member, or each principal officer is deemed to hold one as well. 7.35.2.9 (F), p. 5

A permittee complies with all applicable state, tribal, and local law, including agriculture, environmental health, building and occupancy, fire safety, zoning, and worker safety. 7.35.2.9 (A), p. 5

3. The premises and operations

A producer cultivates, manufactures, and possesses psilocybin only on its permitted premises and does not transport psilocybin outside New Mexico; uses food-grade equipment, counters, and surfaces for post-harvest processing that do not react with any solvent in use; builds and keeps floors, walls, ceilings, counters, and surfaces so as to reduce the development of microbials, molds, and unintended fungi; keeps the premises free of conditions that could contaminate product and suitable for safe and sanitary operation; stores all psilocybin products in a secured, locked area, refrigerated product included; and, on an imminent health hazard that could contaminate product, immediately discontinues operations and notifies the department. 7.35.2.10 (A) through (E) and (H), pp. 5 to 6

A producer sells psilocybin and psilocybin products only to other producers and to practitioners, and otherwise distributes them only to psilocybin testing laboratories or to department employees for testing. 7.35.2.10 (G), p. 6. The August 25 amendments would add healing centers as buyers; see the amendments below.

A producer creates and keeps on the premises at all times written policies and procedures covering at least: instructions for making each product, ingredients and inputs included; the procedure for making each harvest lot homogeneous; safety checks before production; cleaning of equipment, counters, and surfaces; preventing pathogenic organisms and toxin formation; handling and storage of solvents and chemicals per their safety data sheets; waste disposal; use of safety and sanitary equipment; and emergency procedures for fire, chemical spill, and other emergencies. 7.35.2.13, p. 6

A producer complies with sixteen named subparts of the 2022 United States Food and Drug Administration Model Food Code, incorporated into the rule as though set out in it: definitions, personal cleanliness, hygienic practices, numbers and capacities of equipment, location and installation, maintenance and operation, cleaning and sanitization of equipment and utensils, water, plumbing, sewage and other liquid waste, and the materials, design, construction, installation, numbers, location, and maintenance of the physical facility. 7.35.2.23, p. 15

4. What may be made

A producer may not manufacture psilocybin by chemical synthesis, may not adulterate a product or sell or distribute an adulterated one, and must homogenize every product before it is made available for sale or distribution. Products the rule does not authorize may be neither manufactured nor possessed by any permittee. 7.35.2.11, p. 6. The rule's definition of psilocybin excludes synthetic psilocybin and synthetic analogs. 7.35.2.7 (P)(10), p. 3

No pesticide may be applied to fungi or growing medium. Nothing may be added to product, substrate, growing medium, or packaging that increases potency, intoxicating effect, duration, toxicity, or potential for excessive use. The growing medium and inputs are documented in the traceability system; adulterated inputs are not used, adulterated products are destroyed, and their destruction is documented. Product for development that will not be consumed is labeled "NOT FOR CONSUMPTION" in bold capitals of at least 12 points. 7.35.2.12, p. 6

Any product to which a pesticide has been applied, and any product manufactured with an unapproved solvent, is wasted. 7.35.2.21 (A), p. 14

5. Traceability

Every cultivation batch, harvest lot, homogenized lot, and product lot carries a unique identification number in the department-specified traceability system; a cultivation batch is not transferred in its entirety to another producer; an assigned number is never removed. 7.35.2.15 (A), pp. 7 to 8; 7.35.2.10 (F), p. 5

Nine things are recorded in the system, timely and accurately: a complete inventory of batches, lots, and products the producer possesses, controls, or owns; every change to it; when material is converted to waste, and why; when waste is destroyed; any theft; all sales records; the results of all department-mandated testing; and the county and municipality where product was harvested, cultivated, manufactured, tested, sold, and disposed of. 7.35.2.15 (C), p. 8

A producer may apply for a traceability account and department training once it holds a permit, and must have an activated, functional account before operating or exercising any permit privilege. It designates at least one system administrator, may designate further users, trains every user through an administrator, attends and completes the department's system training, may be required to take continuing education to keep the account, and bears every cost of the system, vendor fees included. 7.35.2.16, p. 8

All traceability activity is tracked and reconciled daily. Scales used before entry are certified as registered and calibrated under New Mexico Department of Agriculture requirements. The producer keeps an accurate user list, updates it as users are trained or removed, trains and authorizes new users before access, and cancels a user's privileges once the person is no longer employed. Each individual uses only their own account. On any loss of access the producer immediately notifies the department, keeps comprehensive records of every traceability activity during the outage, enters them once access returns, and documents when access was lost, why, and when it was restored. 7.35.2.17, pp. 8 to 9

Compliance notifications from the system or the department are monitored and resolved in a timely fashion, and may not be dismissed in the system until resolved; informational notifications, enforcement alerts among them, get appropriate action. 7.35.2.18, p. 9

6. Testing

A producer arranges for samples of each homogenized lot to be collected and tested by an approved psilocybin testing laboratory, has testing completed within 30 calendar days of homogenization, and sells or distributes nothing from the lot for consumption until it has passed every required test. The laboratory collects the samples, between 1 and 5 grams per kilogram of product in the lot, under its own protocol; the producer may set reasonable contamination precautions for the sampling visit but must give laboratory staff access to the whole lot. 7.35.2.19 and (B), pp. 9 to 10

Five tests are required before release: visual inspection at 40x magnification (no insects, hair, eggs, or feces; no more than two percent sand, soil, mold, or rocks in a one-gram sample); microbiological testing against the action levels of Table 1, E. coli at 100 CFU per gram and total yeast and molds above 1,000 CFU failing, with Aspergillus, Salmonella, Shiga-toxin E. coli, Clostridium botulinum, Pseudomonas aeruginosa, Listeria, and Trichoderma failing if present; water content below 10 percent; potency, reporting psilocybin, psilocin, norbaeocystin, baeocystin, and aeruginascin in milligrams per gram (Table 2); heavy metals below the Table 3 action levels of 0.2 micrograms per gram for arsenic and cadmium, 0.5 for lead, and 0.1 for mercury; and pesticides below the Table 4 action levels, with any pesticide not registered with the New Mexico Department of Agriculture for use on psilocybin failing at 0.02 micrograms per gram. 7.35.2.19 (D) through (I), pp. 10 to 12

The department may delay or suspend the sample collection, testing, and labeling requirements in whole or in part, and sets start dates with regard to whether a laboratory has validated a method for each test and to laboratory capacity. No start date is in the rule. 7.35.2.19 (A), p. 9

After sampling, the lot is segregated in a secure container under controlled temperature, humidity, and light, labeled with its traceability number, the laboratory's name, the sampling date, and "AWAITING TEST RESULTS. DO NOT USE." in capitals of at least 12 points, until the certificate of analysis arrives. Both the producer and the laboratory document the sampling and testing in the traceability system. The producer keeps all test results for at least two years and makes them available to practitioners and patients on request. 7.35.2.19 (K), p. 12

Homogenized lots and the product lots derived from them are re-tested for potency, water content, and microbiological contaminants no less than five and no more than six months after the previous test, to the same standards. A failed sample may be re-tested by the same or another laboratory, and the lot released if the repeat passes. 7.35.2.19 (L), p. 12

A lot that fails is subject to recall and destruction: the producer removes it from inventory; notifies everyone who received product from it and recalls the product; the practitioner who dispensed consumed product forwards the notice to the patient; the removal and the recall notice are entered in the traceability system within 24 hours; and the recall's success or failure within seven calendar days. 7.35.2.19 (M), pp. 12 to 13

The department may sample and test on its own initiative, may adopt a randomized schedule of no more than four samplings of a producer in any 12 months, may prohibit sale of product it finds contaminated or improperly tested, and on a complaint may inspect and require samples outside that cap; the department transmits any complaint to the producer within five business days; the producer allows access, bears the cost of department-required testing, and records department samples in the traceability system within 24 hours, retaining the record two years. 7.35.2.22, p. 14

7. Packaging, the label, and the product information document

Packaging for product intended for sale or distribution protects it from contamination and excessive moisture, imparts no toxic or harmful substance, displays nothing untruthful or misleading, and does not feature a design attractive to minors. 7.35.2.14 (A)(1) to (3), p. 6

The label, in a legible font of at least eight points, in English, unobstructed and clearly visible, carries the producer's business name and permit number; the type of product; the species and cultivar of fungi; the net quantity in metric units; the potency in milligrams from laboratory results, as total psilocybin equivalent and total potential psilocin; the product lot's unique identification number; the expiration date; the statement "Keep out of the reach of children"; and a department-designated logo at least half an inch square indicating that the product contains psilocybin. 7.35.2.14 (A)(4), pp. 6 to 7

A producer generates a product information document, printed and electronic, in English in at least 12-point type, and makes it available to qualified patients and practitioners. It carries everything on the label; the years the business has been established in New Mexico and the state and country of residency, with length, of every owner and investor; every laboratory test and re-test result on the homogenized and product lots; the growth medium's type and composition; the dates of manufacture and homogenization; all ingredients in descending order by weight or volume; potential major food allergens in the product or the medium; intended use and directions; storage instructions; the FDA statement quoted in the rule, including the pregnancy and breastfeeding caution; the statement that the risks, benefits, drug interactions, and effects of psilocybin are not fully understood; the statement not to drive or operate machinery; and the telephone numbers of the New Mexico poison and drug information center and the New Mexico crisis and access line. A practitioner gives the document to the patient before administration and, on request, makes reasonable efforts to provide a translation or an accessible format. 7.35.2.14 (B) through (D), p. 7

8. Wastage

Psilocybin is wasted by destroying it or incorporating it into other material so that it is unusable; disposal follows all applicable waste law; wasted product is never worked into anything for human consumption. Wastage is recorded in the traceability system within 24 hours, with the batch or lot number, weight, the dates of wastage and disposal, and any associated test results, and deducted from inventory; the record is kept at least two years after disposal. 7.35.2.21 (B) through (E), p. 14

9. Transportation

A producer develops and maintains a written plan for safe transportation. Under the adopted text, psilocybin is transported only by persons holding a permit, or by designated employees or contractors of a permittee or a certified practitioner. Before any transport the permittee completes a chain of custody form, generated and submitted through the traceability system, for testing and sampling, for sale, and for destruction, wastage, or disposal; only what is on the form travels. 7.35.2.24 (A)(1) and (2), (B), p. 15

Psilocybin travels inside a motor vehicle in reasonable operating condition, not visible or identifiable from outside, locked in a box, container, or cage secured inside the vehicle, trunk included; the vehicle is locked when unattended, has an alarm, and is registered with the motor vehicle division; nothing is opened or tampered with in transit; multiple approved locations may be served in one trip; no deviation from the route except for rest, fuel, or repair; the vehicle is subject to department inspection at any permitted premises or in transit; conditions in transit protect against contamination and deterioration; and the driver is prepared to show an employee badge, driver's license, registration, proof of insurance, and the chain of custody form to law enforcement or the department. 7.35.2.24 (A)(3) through (13), p. 15

The permittee receiving a shipment verifies it against the form, and no permittee takes possession of or transports psilocybin that is not on the form or differs in amount from it. The transporting permittee is responsible for any discrepancy; the form may not be voided or altered after departure; a chain of custody document accompanies every transport. 7.35.2.24 (C) through (G), pp. 15 to 16

10. Monitoring, corrective action, and discipline

The department may assess a permittee or applicant on site, with or without notice, during normal business hours; may review any record of the operation, including financial and sales records, with immediate access to inspect or copy them on request; may interview persons affiliated with the permittee; and refers complaints alleging criminal activity to law enforcement. A deficiency the department notices is corrected within 30 calendar days. Sales and invoicing records are kept in a department-approved format, their location disclosed, and their removal promptly reported. 7.35.2.25, p. 16

Where immediate action is necessary to protect public health and safety, the program administrator may suspend a permit at once, in whole or in part. The permittee may request a record review in writing within 30 calendar days of the notice, by postmark, stating a rebuttal or showing the issues resolved; the decision issues within 15 calendar days of receipt, by certified mail. 7.35.2.26 (A), pp. 16 to 17

Disciplinary action, which may be revocation, suspension in whole or in part, denial of an application, or other action, may rest on thirteen grounds: any violation of the rule; selling or distributing inconsistently with rule or statute; threatening or harming a patient, practitioner, clinician, guide, or department employee; destroying, altering, or concealing evidence, or asking another to; willful or reckless disregard for health or safety; refusing requested access; falsification or misrepresentation to the department; failing to adhere to any attestation or representation; failing to submit required information; failing to correct a cited violation; a discrepancy between a chain of custody form and the transported product; a tax authority's finding of non-compliance; and a department finding of nominal ownership. 7.35.2.26 (C), p. 17

A permittee served with a notice of contemplated action, or an applicant denied for a reason other than an incomplete application, may request a hearing by certified mail within 30 calendar days. A hearing officer appointed by the secretary holds it in Santa Fe, or by telephone or video if the permittee is more than 100 miles away or the parties consent, within 60 calendar days of the request unless extended. The appellant bears the burden of proof by a preponderance of the evidence; the rules of evidence do not apply; a party may appear with a lawyer, a non-lawyer representative, or alone. The hearing officer recommends within 30 calendar days of the last submission; the secretary decides within 45 calendar days of the recommendation, by certified mail. 7.35.2.26 (D) through (P), pp. 17 to 19

11. What the August 25 amendments would change for a producer

Three sections of the adopted text are proposed for amendment, published August 25, 2026 and heard October 2. None is in effect until adopted. The proposed amendments; the hearing notice.