FDA/GMP Cannabis Compliance

The High Risk and Complexity of Cannabis Compliance

Regulatory compliance is one of the areas operators find least interesting, yet it is one of the highest areas of risk for a cannabis industry business. With such high stakes and complexity, you don’t want to risk handling this responsibility on your own. Instead, operators can trust Canna Advisors as a reliable cannabis compliance resource for this topic that must be addressed, and must be addressed correctly.

The one fact that is clear in maintaining compliance – it will get more difficult as more and more regulations are applied. Regulations are always changing, and local-level and state-level regulations can be in conflict.

Our experienced compliance professionals can help you navigate your own set of regulations based on your operations and location. Another benefit of trusting Canna Advisors with your compliance concerns is the team’s broad network of relationships and track record of industry advocacy. The Canna Team can connect you with with committees, lobbyists, and other resources to help refine regulations so they’re more favorable to business in your area.

In the cannabis industry, flawless compliance is of the utmost importance. As some of the first organizations to forge the path, the scrutiny is intense and opponents are looking for errors and waiting to catch mistakes to support their cause. Bringing the experienced compliance resources of Canna Advisors to your team can help you uphold this high standard and help build favorable impressions of the cannabis industry.

Hourly Consultation

Ready to get started with an hourly consultation? Our experts can answer your questions and provide insights to help you chart your path.

Are you ready for the FDA? Compliant processing is about to change. 

It's expected that forthcoming FDA regulations may cause as many as 30% of current cannabis processors and manufacturers to close their doors.

Whether you are pre-license, pre-operational, or already up and running, you'll need to to meet FDA/GMP compliance standards to remain viable.

Our leading team of experts and Industry Alliance partners can deliver everything cannabis processors and manufacturers need to build or optimize a GMP-compliant extraction operation.

FDA/GMP compliance will impact your business plan, financial model, assumption testing, and facility selection and design.

Understanding the Compliance Environment

From the licensing process to renewing your license is a big area of risk. The window of time to submit for renewal or report changes to ownership, personnel, or location is very specific. If employee badges expire, for example, and they are still working, you will be hit with big fines.

Tracking and reporting requirements are heavy — some daily, some weekly, quarterly, or yearly — and can take a full-time employee or full team to manage this closely and accurately. Dispensaries are the most exposed and visible part of the industry to the public because they have the most interaction with the outside community. With this exposure comes a responsibility to ensure that all appearances convey professionalism and are a positive representation of the industry.

Common Infractions & Changes in Regulations

It is important to conduct external business compliance audits at least on a quarterly basis, along with full internal audits and internal spot checks for inventory and cash. There should also be full audits directly after new regulation has passed, before implementation is required.

 

Common Cultivation Infractions:

    1. Not reconciling all on-premises inventories at the close of business each day.
    2. No documentation for material changes for standard operating procedures and regulated processes.
    3. Lack of complete inventory of material safety data sheets where the product is used or stored.
    4. Inadequate Chemical and Pesticide Application Log
    5. The cultivation facility has not properly documented all waste and waste removal.

Common Dispensary Infractions:

    1. Not immediately inputting all products into the state-mandated inventory tracking system and accounting for all variances
    2. Tracking logs for visitors, security, and/or waste are not accurate or updated
    3. Incomplete financial business documentation available as required by federal and state regulations
    4. Missing or incomplete public health and safety warning statements on products sold
    5. Inadequate and/or obstructed surveillance cameras

Compliance with cannabis laws is everything

We know the fine print in every state’s cannabis regulation, and we can help you manage complex regulatory compliance issues.

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