How to Prepare for Healthcare Merchant Accreditation

Prior to applying, review the Healthcare Merchant Accreditation Eligibility Requirements.

• If you are a compounding pharmacy or a telemedicine platform that uses a compounding pharmacy for fulfillment, you may be ineligible to apply if the pharmacy has an unresolved Food and Drug Administration (FDA) Warning Letter(s) and/or unresolved FDA Form 483 Notification(s) regarding compounding.
• You can use FDA’s Compounding: Inspections, Recalls, and other Actions page to find most FDA actions and determine (1) if a compounding pharmacy has any FDA Warning Letters or published FDA Form 483 Notifications and (2) whether those issues have been publicly resolved.

If your website collects protected health information and/or payment information, make sure that your website is secure.

• In case it is helpful: A secure website URL will start with “https” instead of “http.” The “s” in “https” means the website is configured to use a Secure Sockets Layer certificate. In most web browsers, you can also look to the left of the web address and check the security status symbol to confirm the website is secure.

• Any covered entity “must prominently post and make available its notice on any website it maintains that provides information about its customer services or benefits.” See the HHS site for more information.
• In case it is helpful: Many pharmacies customize and post a Model Notice of Privacy Practices with their pharmacy name, contact information, and other required data points.

If your business sells ingestible cannabidiol (CBD) products, be aware that, under federal law, it is illegal to market CBD by adding it to a food or labeling it as a dietary supplement. CBD is also prohibited in animal food products. However, cannabis-derived ingredients are currently permitted in cosmetics. NABP requires that applicants and accredited entities comply with Standard 5, which requires adherence to federal law even if CBD products are legal in your state.

If you carry any products that contain CBD, when you submit your application, you will need to provide clear product label images, including full ingredient panels, for all CBD products offered for sale.

Ensure that your website posts the physical address and phone number of the business – and that it can easily be found by website visitors.

NABP’s Standard 9 requires that the domain name registration information of the applicant’s primary website be accurate, non-anonymized, and have a logical nexus to the merchant.

What does this mean? Ensure your website’s domain name registration information is public.

• You can confirm the status of your domain name registration information at whois.domaintools.com (look under “Whois Record”).
• If you use GoDaddy.com, LLC, they provide instructions for how a privacy proxy can be removed.
• If you do not use GoDaddy, ask your Information Technology department or the team that helped you build your website to help with this task.

All applicants need to comply with NABP’s 10 Program Standards. Standard 10 (the “Affiliate Standard”) states that a “merchant’s Affiliates must comply with all program standards.” The term “Affiliate” is defined broadly. Read this standard carefully to avoid delays in your application.

What does this mean for your application? This means that NABP will ask questions about your Affiliates to determine if they are also in compliance with the Program Standards. Some examples:

• If you operate a pharmacy that provides fulfillment services for telemedicine platforms, you will need to provide information about your telemedicine Affiliates. (See the “Telemedicine Applicants” section.)
• If you operate a telemedicine platform that uses one or more fulfillment pharmacies, you will need to provide information about them. See the “Pharmacy Applicants” questions below for details regarding the information you will need.
• If you are part of a health care group that includes multiple pharmacies and/or other health care services, our review covers all of these providers. For example, if your pharmacy is a single location within a larger health system, we will also review the health system’s other pharmacies and its telehealth services.
• We strongly encourage applicants to proactively reach out to their Affiliates to gather the required information before submitting their application.
• Tip: NABP has worked with many applicants who have been able to obtain information directly from their Affiliates. In our experience, organizations typically have pre-existing documents of this type as part of their internal compliance programs.

Be sure to submit licensure for all states where all pharmacy locations and pharmacist(s) in charge are licensed. Use our Pharmacy Licensure Template to provide this information.

• First, take a look at NABP’s Terms and Conditions, where we define “Adverse Action.”
• If your company has any Adverse Action, provide (1) all relevant documentation (including information from state and federal agencies) and (2) a description of the corrective actions taken to resolve the issue(s), if applicable.

If yes, compile a list of the top 20 sterile and top 20 nonsterile compounded substances, including their composition, dosage form, strength, and route of administration.