Resources for Laboratories Seeking Accreditation for Psilocybin
Laboratories performing testing of psilocybin products must be accredited by ORELAP. Interested laboratories must submit a completed application, undergo an onsite inspection, and meet other applicable requirements as determined appropriate by ORELAP by rule.
News
Permanent changes to OAR 333 Division 64 establishing rules for psilocybin testing laboratories effective December 27, 2022
- Defines the regulated tryptamines.
- Describes requirements for chemical analysis and speciation testing of psilocybin products.
- Incorporates by reference the sampling protocol laboratories must follow when sampling psilocybin products.
- Establishes a foundation of rules for psilocybin sampling, testing, reporting, and enforcement.
- Includes editorial revisions to multiple sections of the rules.
- For links and more information go to
ORELAP Rules and Statutes.
ORELAP is now accepting applications for psilocybin testing. Please review the document directly below for more information.
The Accreditation Process
The process begins by registering for a username in our ORELAP Data Input and Edit (ODIE) system (a link to ODIE is located on the homepage). Once registered, the user can create an initial application for accreditation. The laboratory's application will be reviewed and invoiced in the order it is received. Once the invoice has been paid, ORELAP will arrange for an onsite assessment. The assessment will determine the laboratory's compliance to the accreditation rules and the 2016 TNI Standard. If the laboratory successfully completes and passes the onsite assessment, a certificate of accreditation will be awarded to the laboratory with an issued date and expiration date. The laboratory must renew its accreditation annually thereafter and will be subject to follow up onsite assessments every two years. Those unfamiliar with the ORELAP accreditation process will want to make sure they get up to speed now. Obtain a copy of the 2016 TNI Standard and become familiar with the requirements for accreditation. Make sure there are personnel at the laboratory who meet the educational and experience qualifications for the technical director and quality assurance officer positions. Assessments cannot be scheduled until invoices are paid and the laboratory has qualified personnel. Be prepared to show assessors method validation data (as described in the appropriate modules of the TNI Standard).
Sampling Protocol