All adult-use and medical cannabis products in New York State must be processed according to Good Manufacturing Practice (GMP) standards. It is mandatory for all licensees and registrants to comply with GMP for the duration of their license. The objective of imposing GMP standards is to ensure cannabis products are consistently safe, high-quality, and produced under controlled (sanitary) conditions.
What Is GMP?
Good Manufacturing Practice (GMP) is a federally recognized quality control system that is governed by two FDA regulations:
- 21 CFR Part 111: Dietary Supplements
- 21 CFR Part 117: Food Safety (Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls)
Under the GMP system, your facility must follow rigorous standards designed to ensure consistency in your products, consumer safety, and regulatory compliance at each step of the manufacturing process, including:
- Cleanliness and sanitation
- Controlled processes and equipment
- Proper employee training and hygiene
- Documentation and record-keeping
- Consistency and quality assurance across every batch
However, some licensees may qualify for conditional exemptions:
- Eligible Licensees:
- Adult-Use Cannabis Processor Type 3 licensees (Brand Owner licenses)
- Microbusiness licensees
- Exempt Activities: Limited processing tied to packaging, labeling, or branding of specified products.
- Conditions:
- Exemption applies only to those limited activities.
- Must submit a formal exemption request.
- Exemption is valid only with written approval from the New York State Office of Cannabis Management (OCM).
These exemptions temporarily relieve these businesses from certain regulatory requirements such as full GMP compliance. They are granted under strict conditions and have defined timelines.
GMP Audit Requirements
Your cannabis manufacturing facility must undergo a third-party GMP audit promptly after licensure to ensure safety and quality of your products. Internal audits should be performed regularly (e.g., quarterly or annually).
- Timeline: Within one year of starting operations, every licensee/registrant must submit proof of a qualified third-party GMP audit.
- Scope: The audit must cover extraction and/or manufacturing processes at your facility, depending on your license type.
- Submission: Documentation must be provided to the OCM to their satisfaction.
This audit serves as independent verification that your facility is operating in compliance with GMP standards.
The OCM provides detailed guidance to help licensees on the OCM website.
If your cannabis manufacturing business needs assistance with OCM compliance, reach out to Tracy at [email protected].
Tracy Jong is a Senior Attorney at Evans Fox LLP with 30 years of experience focusing her practice in business law, intellectual property and licensing for alcohol and cannabis. Tracy Jong is a member of the New York Bar and is a registered attorney at the United States Patent and Trademark Office. She can be reached at [email protected].
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The content has been prepared for informational purposes only; it should not be construed as legal advice, does not create or constitute an attorney-client relationship, and readers should not act upon it without seeking professional counsel.