PFC works at the local and state level acts to increase awareness of the AHPA standards and the AHP Cannabis Monograph with relevant agencies. PFC and AHPA work directly with legislators, regulators and industry trade groups to encourage the adoption of AHPA’s Recommendations to Regulators and standards outlined in the AHP Cannabis Monograph. As such, regulators in the states of Alaska, Florida, New York, Illinois, Maryland, Nevada, Washington, Oregon, Massachusetts, Minnesota, Hawaii, and Colorado have adopted portions of the AHPA’s Recommendations and/or the AHP Cannabis Monograph.
As the regulatory framework for medical cannabis businesses continues to develop throughout the US demonstrating adherence to national best-practice standards can help businesses avoid being subjected to the development of onerous state and local regulations that may challenge the ability of small businesses to be successful. Throughout history, big business, with the support of government, has used unnecessarily narrow or stringent regulations to monopolize marketplaces. Certifying your business with PFC shows regulators and lawmakers that your business has high standards of operation in accordance with other botanical products, discouraging the development of overly restrictive regulations.
Both ASA and AHPA are dedicated to the adoption of mandatory standards for the medical cannabis industry nationally. Your participation in the PFC helps to ensure our outreach to your specific regulators gives your company an advantage.
Prepared for regulatory inspections
In today’s regulated marketplace, failure to meet regulatory compliance can result in the denial of licensure for an applicant or, in the case of an established company, can result in costly fines recalling or confiscation of products, and even suspension or termination of your company’s license. As a participant in the PFC program, your company can rest assured that PFC’s inspection auditors will identify any and all compliance issues that could jeopardize your company’s ability to maintain compliance with local and state regulations. As localities and state regulators adjust and update regulations, PFC staff will ensure that your company is aware of all upcoming regulatory changes while offering solutions for maintaining compliance as rule changes take place.
Reduce company liability
Prior to the adoption of product safety guidelines in the herbal, botanical, and nutraceutical industries product liability lawsuits continually challenged the stability, growth, and future of these companies. As public concern in the US mounted over the increasing number of product liability lawsuits larger agencies such as the FDA entered into the conversation about regulations and pressures rose to restrict herbal, botanical, and nutraceutical products from public availability. However, through the voluntary adoption of rigorous product safety guidelines, the herbal, botanical and nutraceutical industry was able to ease the concerns of both the public and regulatory agencies allowing the industry to stabilize and avoid overly onerous FDA regulations.
Today, the medical cannabis and adult use industry find themselves in a very similar situation. As medical cannabis and adult use laws have been implemented throughout the US, product safety has been an afterthought in many of these laws. By working with PFC to adopt nationally recognized product safety standards, you directly reduce your company’s service and product liability. Through proper lot and batch number tracking, health and hygiene protocols, standardized testing, proper labeling, as well as adverse event reporting and recall strategies cannabis businesses act to raise the bar of product safety to that of the herbal, botanical, and nutraceutical industry in the US.
PFC certification helps your company identify, develop and address product safety protocols before a product safety liability issue can arise. Engaging in the PFC program costs the average company less than 1% of their annual revenue whereas product liability lawsuits often cost companies hundreds of thousands of dollars. Let PFC help your company develop a solid foundation of product safety and avoid costly product liability lawsuits that often irreparably damage businesses or close them all together.
Instill confidence in consumers and health care providers
The PFC seal displayed by cannabis businesses and on cannabis/hemp products provides medical practitioners, patients, and regulators with peace of mind that your company is adhering to regulatory guidelines. The seal also shows that your company is committed to the purity and identity of products being sold, has implemented lot and batch number tracking protocols including an operations product recall plan, and has implemented standardized methods for the cultivation, manufacturing, distribution, and lab testing of those products.
Additionally our outreach programs educates patients, their caregivers, and medical professionals to look for PFC certified products so that they can choose their medicine with confidence that it was produced in an manner that provides consistent results and protects consumer safety. PFC’s advertising and marketing prominently features our certified companies and includes both traditional industry publications and unique channels, such as Complementary and Alternative Medicine outlets.
Confidence in compliance
As medical cannabis, adult use, and hemp businesses have emerged in the legal marketplace , state and local lawmakers have created a patchwork of laws and regulations. Almost all companies entering into the PFC program will find that some form of corrective action is necessary to achieve and maintain certification. Let PFC help your company achieve excellence in compliance, Best Business Practices, quality of care, and product safety.
Due to the ever-changing and expanding nature of medical cannabis regulations and medical cannabis industry innovations, PFC recognizes the need to adopt new standards and guidelines as regulations change and has been developed as a continually evolving program overseen by a Peer Review Board which along with AHPA and AHP will oversee and approve the ongoing update of PFC program standards. Depending on the extent of standard updates, a PFC auditor may be assigned to the affected companies to verify that all necessary compliance updates have taken place. Additional staff training may also be required. The addition of program requirements, determination of corrective actions, and need for additional trainings, will be determined by the PFC Peer Review Board.
More than one-third of the US population lives in states with medical cannabis laws and over one million Americans are legally using medical cannabis under the care of a physician. While many states and localities have created regulations to govern the location, size & taxation of these business, they do not, for the most part, address the quality and safety of the products being sold.
Patients have the right to know how their medicine has been produced, that is free of contaminates and should be confident that the medicine they are receiving has been handled with the highest quality of care. Patients can now look for the PFC when deciding how to choose their medicine.
What does the PFC Seal tell you?
When you see the PFC seal at a distribution center or on a product label, it tells you that the quality of products and services has been verified through the rigorous Patient Focused Certification program.
When you choose PFC you can be ensured that:
- The company’s staff is well trained
- Products and services have been tested for contaminates
- Products and services meet legal requirements as well as AHPA and AHP Standards
- Companies have recall protocols in place
PFC is the only certification based on the new quality standards for medical cannabis products and business issued by the AHPA and AHP. Available in all states with adult use and/or medical cannabis laws, PFC includes employee training, on-site compliance inspections, product testing, ongoing monitoring and an independent compliant process for customers. Companies certified by PFC are demonstrating a commitment to safety and quality.
Every application is reviewed by a PFC representative who uses the information you provide to build a certification quote. Every quote is tailored to the details of your specific business with pricing customized to your operation. PFC pricing is based primarily on the type of certification requested, the number of facilities to be certified, and the number of employees. When applicable, other factors such as square footage of cultivation space and the manufacturing process(es) conducted on-site are also taken into account. All of this information is taken from your application and computed through our pricing matrix. We use a pro-rated pricing methodology, so you’ll only be charged for the services you need.
Yes! The PFC application is free and there’s no obligation. A PFC representative will tailor a quote to your current estimates even if you’re in the beginning……you’re not sure of how many employees you will have on staff, how much cultivation space you will grow, or what medications you will produce. You can either include your estimated ranges in the online application or call us at to speak with a representative who will walk through the application with you.
Businesses waiting for state-level permitting can apply for PFC today. We offer a pre-licensing option to certify your SOPs in advance and conduct the audit once a permit is granted, as well as advising services to assist with SOP creation and implementation.
Our quote is a no-hassle, no-obligation, line item breakdown of PFC costs. The quote will tell you the cost of certification based on your application. We will prepare and send you a quote and contract within 7 business days of receiving your completed application. Each quote is prepared and reviewed by our team to provide you with the best pricing we can offer. The contract provides all the details of your certification requirements.
The quote contains a line-by-line breakdown of PFC costs: (1) audit fee, (2) certification fee, and (3) compliance fee.
1. The audit fee includes your initial and unannounced audits for the year.
2. The certification fee includes your graphics and certification package, as well as promotional literature.
3. The compliance fee covers the complaint hotline and any certification challenges. Upon renewal, PFC will credit your business up to 90% of the original compliance fee, based on the number of complaints received.
The quote does not include the cost of training. The training component is a one-time cost, per employee. Training costs are handled by a third party educational provider and a training estimate is provided in the contract.
The quote also contains contact information for your PFC representative and for the applicant.
Once you have reviewed the quote and contract, sign the contract and return it to PFC to move forward with the certification process. When we receive your signed contract, a PFC representative will contact you to verify your application details and prepare an invoice.
The pricing quote is based on the information provided in your initial application. Unless the size or scope of your business changes, the invoiced cost will be the same as the quoted cost.
There is no obligation to sign the contract if you decide PFC is not right for business.
Every company has corrective actions. Our job is to find those issues and remedy them before regulators find those issues. The compliance components of PFC address local and federal regulatory criteria above and beyond what is often required in a jurisdiction. Every operator with PFC will not only satisfy their local requirements but will follow best practices for the industry and standards for botanical medicines.
PFC recognizes endorsing organizations ongoing work with their members to insure compliance with local and state regulatory guidelines. As such, PFC is pleased to offer discounts to organizations working directly with the PFC program. Once PFC has approved your association’s, or accrediting group’s endorsement , PFC will happily offer all members and companies acknowledged by your group a 5% discount on PFC certification.
PFC is pleased to offer discounts to members of organizations that have endorsed the PFC program. Endorsing organization discounts can be combined to provide your business with a maximum 15% discount on certification. PFC can also offer group discounts for organizations that want certify 10 members, or more, at a given time.
Third-party certification ensures that an independent organization has reviewed the manufacturing process of a product or management process of a service and has determined that the final product complies with specific standards for safety, quality, or performance. PFC certifies compliance with AHPA and AHP standards for medical cannabis products and services. This review typically includes comprehensive reviews of formulations and materials, independent testing, and facility inspections. Certified products typically exhibit the certifier’s ‘mark’ on their packaging to help consumers make educated purchasing decisions. PFC requires annual inspections, unannounced random inspections, and product testing to ensure that certified companies continue to meet all AHPA standards after the initial certification. Other nationally recognized certification programs include Good Housekeeping, NSF and ISO.
Available in all states with adult use and/or medical cannabis laws, PFC is available to all qualifying companies cultivating, manufacturing, or distributing medical cannabis products, as well as to laboratories providing medical cannabis analytics.
Participating in the PFC program costs the average company less than .3% of their annual revenue and shows regulators, patients and medical practitioners, that your company is invested in the wellbeing of it’s clients and has a staff educated to a high standard of care. Companies certified by PFC are demonstrating a commitment to safety and quality.
PFC works with companies who voluntarily participate in the program and agree to adhere to local laws, AHPA and AHPA standards. Companies are verified through a comprehensive evaluation process. Independent auditor’s complete comprehensive evaluation process producing a detailed audit report, including corrective actions if necessary.
- Perform thorough audits of the facilities
- Test products in PFC certified laboratories
- Conduct at least one (1) surprise audit a year to ensure PFC standards are being upheld
- Ensure companies maintain a consumer complaint database and follow-up with the company for any and all corrective actions
- Ensure PFC seal is used only on products that meet PFC quality standards
The length of time required to complete the certification process depends on several variables including: the discipline(s) and size of facility, number of employees, and complexity of operations. The amount of time it takes a company to achieve readiness for certification depends on the quality of management systems currently in place. PFC provides optional advisory services to identify and resolve documentation and process deficiencies in advance of the audit process.
The speed of the certification process is dependent upon timely and complete responses from the applicant. A typical certification process will follow a timeline similar to the following:
- Application Submitted
- Quote Issuance
- Contract Execution
- Preliminary Assessment Completion (optional)
- Documentation Audit – (3-5 business days)
- Facility Audit/Product Testing – (3-5 business days)
- Corrective Action Period (if necessary) – (5-15 business days)
- Final Review, Report and Decision – (5-10 business days)
Your company is ready for certification after you’ve implemented good management practices based on AHPA standards, trained employees to become proficient with processes, and developed a sufficient evidentiary trail of documents that can be assessed. PFC staff can provide applicants with discounted training programs, as well as document preparation and advisory services to help you company prepare for certification. Please contact PFC for additional information on supplemental services.
The first day of the audit, the PFC team will meet with company management and other staff and contractors directly involved in the company’s management system. The meeting will include an overview of the audit process to give you clear expectations for the process. During this meeting, ASA will review the audit scope and objectives, confirm the audit schedule and resources, and review the procedures for identifying and reporting deficiencies. You will be required to provide a main point of contact to accompany the PFC team through the audit process.
Upon completion of the on-site audit, the PFC team will conduct an exit meeting. A summary review of the facility audit will be given to management. If any deficiencies were recorded, they will be described at this time and included in a facility audit report. You will be given a reasonable time period to take corrective action.
Each applicant has its own unique characteristics that will determine the cost of certification. Two key elements comprise the cost of certification: size and complexity of the operations. As the size of a company increases so does the number of patients or consumers engaging in the company’s services or products. PFC’s patient and caregiver educational program serves to provide your business with plenty of educational materials designed to help consumers understand the importance of the PFC seal of approval.
All quotes also include the cost of the initial pre-certification audit plus the required compliance audit. As a company grows in size and possibly in complexity of operations so does the amount of time necessary for a thorough audit of the company. For example, a company that dispenses medical cannabis often requires much less time to audit than a company that cultivates and manufactures medical cannabis. As such these scalable costs are reflected in the PFC quote. PFC will provide a quote after a complete review of your application.
This quote is an estimated cost and will include:
- Fees for preliminary assessment (optional)
- Fees for audits and certification review
- Fees for review and complaint investigation
PFC is committed to providing your company with a quality certification program that adds value to your business. We are committed to providing the most qualified inspection and audit team at the lowest cost possible.
The program’s value drivers include:
- No application fee
- Discounts for some trade association members, AHPA members, and UFCW contracted businesses.
- No mandatory preliminary site visit
- No hidden costs, overtime charges, or penalties for properly noticed schedule changes
- Reimbursable expenses are charged at cost without mark-ups
- Advanced off-site preparation is completed by PFC, reducing travel time required
- Audits include a review of compliance with local and state regulations
- Press release development by PFC outreach staff
- Advertisement of your participation in all PFC ads
Once certification has been granted, the review period begins, and the company may be subject to random and unannounced audits and/or product testing. An annual re-certification process is mandatory. Follow-up audits may require document submissions and/or an on-site visit. Certified companies are required to respond within five (5) business days to any complaint submitted to PFC (by consumers, healthcare providers, stakeholder groups, regulators, etc.) for which a response is determined by the PFC Peer Review Board, to be necessary. PFC will maintain records of complaints on certified companies. Such complaints may trigger unannounced inspections depending on the complaint severity and/or frequency. If for whatever reason certification must be suspended, PFC will notify regulators.
Certification materials include, a certificate bearing PFC’s certification logo, a PFC certification window decal, educational and promotional materials for patients, healthcare providers and regulators and PFC website links.
The assigned PFC auditor and PFC staff will monitor certified operations throughout the annual certification period. In the event of a law or regulation change, or when AHPA or AHP releases updated standards, a review audit may need to be completed. PFC will notify certified companies of any updates to standards and provide an explanation of actions required by the company to comply with said update, including a required timeframe for compliance.
Additionally, if any third-party complaints require an investigation or a large number of complaints are received, a review audit may be necessary. PFC will evaluate and respond to all third-party complaints verifying the legitimacy and severity of the complaint, and when necessary, requiring immediate corrective action. Certified companies are required to respond to complaint inquiries within five (5) business days of notification by an assigned PFC auditor or staff person.
PFC shall investigate complaints related to certified companies, including but not limited to violations of regulations, adulterated products, improper labeling, the misuse of the PFC logo by certified companies, or use of the PFC logo by non-certified companies. Failure to cooperate in a complaint investigation will result in the immediate termination of PFC certification.
When filing a complaint, a Complaint Investigation Request provided by PFC must be completed and signed by the complaining party. Complaints will be sent directly to the Program Director, who will track all complaints and investigations. PFC will acknowledge receipt of the complaint, promptly investigate and validate the complaint, and take appropriate actions. PFC shall ensure the proper corrective actions have been implemented and notify the complainant of such actions. The certified company will be advised of the complaint at the appropriate time during the investigation. PFC shall determine, together with the certified company and complainant (and regulators where necessary), if the complaint and resolution should be made public.
When a complaint is made by a company, whether PFC certified or not, the complainant agrees to bear the cost of an investigation if the complaint is not verified. If the complaint is substantiated, the certified company shall be responsible for all costs of the investigation. Regulatory authorities, individual consumers, and licensed health care providers are exempt from bearing the costs of any investigation. PFC shall not identify the complainant unless required to do so by law. If a complainant does not sign a Complaint Investigation Request, PFC will consider it an informal complaint and will investigate as needed but has no obligation to investigate or respond.
ISO compliance will help an operator pass a PFC inspection. ISO 17025 accreditation ensures compliance with a specific set of laboratory methods, PFC compliance ensures compliance with botanical health and safety standards, and criteria for validating specific methods. Both PFC and ISO require significant documentation and method validation, but ISO depends on the operators being forthright whereas PFC compliance hinges on the operator providing requested documentation i.e. ISO (e.g., 17025) audits whatever an operator presents as part of a “quality manual.” There could be a 1,000 procedures being used in the lab and only 1 could be in the quality manual. For an ISO audit, an operator is expected to show/help auditors identify “conflict” or corrective action areas, while PFC asks for specific criteria provided by the AHPA’s Recommendations to Regulators and the AHP Cannabis Monograph.
ISO is used for commercial labs operating outside stateliness, laboratories are encouraged to get ISO but even their guidebooks suggest that local guidelines and standards are important for operating locally, if such guidelines are available. ISO is often used when there is absence of a compliance or certification body, such as in a small country with a few labs.
ISO is context deficient for medical cannabis operators. It doesn’t tell you if the business is a good cannabis operation or not because it only informs on what is needed to do an aspect of their work, regardless if it is legal or meant for human consumption. PFC offers training in specific areas of cannabis that are used by operators and health department inspectors in compliance audits, ISO does not require that the staff be trained in specific areas essential for operation in the cannabis industry. Sample handling, storage, security, legal operations issues (ISO does not check licensing or permits from the state) are examples of best practices and regulatory requirements that ISO does not fully address for the cannabis industry.
Analytical Chemistry cannot be properly dealt with if its relationships with written standards are not taken into account in order to efficiently contribute to the continuous improvement of human activities.
“…the key issue in selecting an accreditation body is to ensure that it has recognition in the context in which the laboratory’s data needs to be used. Where a laboratory operates purely in a domestic market and where the data is used only within the country, for example for local food safety or environmental protection, then a national accreditation body, even one with no international recognition, will normally be entirely suitable.” -From “Complying with ISO 17025: A practical guidebook for meeting the requirements of laboratory accreditation schemes based on ISO 17025:2005 or equivalent national standards published by UNIDO (United Nations Industrial Development Organization)
If you are not approved for certification, a PFC representative will arrange a meeting between you and the PFC Program Director. The PFC Program Director will work with you to come up with a list of “next steps” to get you certified and a timeline for completion. When you have completed these steps, you will send the necessary documentation to PFC and the PFC Review Board will reassess your certification for approval.
Don’t panic! Many business are not fully ready for certification and all audits result in corrective actions. After the initial on-site audit is conducted, the audit report and audit checklist are sent to the PFC Review Board for final review and certification approval.