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Since the release of the AHPA and AHP guidelines, states have been using them as legislative and regulatory tools  to create comprehensive product safety rules and regulations. However, these new regulations will only be effective with proper oversight and enforcement. To aid government agencies in these efforts, ASA has created the Patients Focused Certification (PFC) program. PFC is a non-profit, third party certification program for the medical cannabis industry and the nation’s only certification program for the AHPA and AHP standards. PFC is available to all qualifying companies cultivating, manufacturing, or distributing medical cannabis products, as well as to laboratories providing medical cannabis analytic services. PFC offers a comprehensive program that includes employee training, compliance inspections, ongoing monitoring, regulatory updates and an independent complaint process for consumers.

The PFC program is currently offered as a voluntary certification program in all medical cannabis states and holds the permit to provide the mandatory education required by the District of Columbia’s medical marijuana program.

The PFC program offers 10 Key Components

  1. offers regulators a third-party auditing option to ensure that licensed businesses are meeting standards required under regulation;
  2. is overseen by a Peer Review Board that has over 300 years of collective expertise in USDA food and product safety protocols; federal regulatory development; and medical cannabis research, pharmacology, biochemistry, and industry practices;
  3. provides a logo that lets consumers, policy makers, regulators, community members and health care providers know that companies are meeting compliance and product safety standard requirements;
  4. monitors violations of regulations as well as complaints from patients, caregivers, health care practitioners, regulators, and community members;
  5. provides trainings that include: Legal Issues, Raid and Robbery Preparedness, Patient Education, Good Neighbor Polices, Safe Handling Protocols, Working with Patient Populations, Understanding Test Results and Delivery Systems, Adherence to Local Laws and Regulations, and Adherence to AHPA and AHP standards;
  6. provides participants with educational materials for patients, caregivers, health care providers and regulators that describe the certification program.
  7. verifies through independent auditors that state and local rules, as well as AHPA and AHP standards, are followed by companies, ensuring patient safety and product quality, purity, and reliability;
  8. offers third-party certification that can help reduce regulatory program cost and oversight burden;
  9. has independent auditors that can be contracted as third-party auditors for regulatory agencies;
  10. provides companies and, if required, regulators with annual Audit Reporting.

As with other industries, oversight of medical cannabis and medical cannabis products is constantly evolving. PFC verifies compliance with state and local laws as well as the AHPA and AHP standards. In order to ensure ongoing compliance, PFC requires comprehensive staff training, annual inspections, unannounced random inspections, and product testing to ensure that certified companies continue to meet all program standards. PFC is similar to other nationally recognized certification programs including USP, Good Housekeeping, NSF, and ISO.

Benefits for Regulators and Consumers

For almost all commercial products that are produced for human consumption there are rules and regulations that ensure legal compliance and product safety. Medical cannabis and medical cannabis-derived products should be no different.  Regulators are constantly making decisions that relate to protection of the health and welfare of consumers, the public, and the environment through the development of new regulations, standards and requirements that keep up with innovative industries and expanding consumer needs. Governments and the citizens they protect are increasingly moving towards zero risk tolerance, often resulting in the adoption of stricter, more comprehensive regulations and reporting requirements.  Companies navigating evolving regulatory frameworks must continually monitor regulatory changes and adhere to regular audits to demonstrate legal and regulatory compliance.

Reduce Cost & Burden to Regulatory Oversight

In order to reduce cost and operational burden to regulatory oversight agencies, regulators are increasingly relying on independent third-party declarations of compliance to support their enforcement and monitoring activities.  Independent third-party declarations demonstrate compliance with legislation and regulations as well as overall performance against industry benchmarks and performance indicators. Third-party certification ensures that an independent organization has reviewed the manufacturing process of a product or management processes of a service and has determined that the final product complies with specific standards for safety, quality, purity or performance. This allows  the regulatory agency to focus on the development of overall policy requirements or detailed technical requirements while relying on approved third-party certification bodies to ensure a high standard of regulatory compliance.

Regulators Program Guide

Download the PFC Regulator Guide Here

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