Eligibility Requirements and Standards
The Healthcare Merchant Accreditation application process includes vetting by NABP to ensure that applicants meet all applicable program standards. For example, applicants must demonstrate licensure in good standing and compliance with the laws of the jurisdiction in which they are based, as well as in all jurisdictions in which they offer to conduct business.
All capitalized terms used, but not defined, in the Eligibility Requirements and Standards have the meanings defined in the Healthcare Merchant Accreditation Terms and Conditions.
The following requirements must be met to be eligible to apply for Healthcare Merchant Accreditation, unless NABP, at its sole discretion, grants a waiver.
I. Types of Organizations that May Apply
This program accredits health care merchants and merchants that are health care adjacent. A health care merchant is an organization that provides or facilitates health care through a licensed health care professional. Health care-adjacent merchants provide services to health care merchants or are intrinsically linked to a field of professional health care (eg, an accredited university or a nonprofit patient advocacy organization). The following is a non-exhaustive list of organizations that may apply for Healthcare Merchant Accreditation:
- Pharmacies (including human and veterinary pharmacies)
- Pharmacy Benefit Management Companies
- Schools or Colleges of Pharmacy
- Continuing Pharmacy Education Providers
- Wholesale Drug Distributors
- Pharmaceutical Manufacturers
- Health care-Related Resources, including:
- Advocacy or Consumer Education Groups
- Drug Information or Pharmacy Referral Sites
- Pharmacy Associations
- Medical Professionals
- Pharmacy Consultants
- Law firms that practice pharmacy or health care law
- Telemedicine Platforms/Companies
- Pharmacy Automation Distributors
- Board of Pharmacy and other regulatory agencies
II. Compliance with Program Standards
Applicants and Accredited Entities must meet the Healthcare Merchant Accreditation Standards at all times during the application process and while holding accredited status.
III. Compliance with Terms and Conditions
Applicants and Accredited Entities must comply with the Terms and Conditions.
IV. Drug Distributor Accreditation Required for Wholesale Drug Distributors or Organizations that Provide Drug Distribution Services
Where: (1) a merchant’s primary business model consists of drug distribution services, (ie, wholesaling); and (2) that merchant seeks eligibility to apply for Healthcare Merchant Accreditation, the merchant must first be accredited through NABP’s Drug Distributor Accreditation program. This requirement enables NABP to ensure compliance with all applicable laws. Eligibility for the Healthcare Merchant Accreditation will typically require Drug Distributor Accreditation for all facilities; however, NABP may exercise discretion regarding which facilities will be required to have Drug Distributor Accreditation as a prerequisite to apply for Healthcare Merchant Accreditation.
V. Merchants Subject to a Food and Drug Administration (FDA) Form 483 Notification
Where: (1) a merchant or its Affiliate (as that term is defined in the program standards) is subject to an FDA Form 483 Notification; and (2) that merchant seeks eligibility to apply for Healthcare Merchant Accreditation, the merchant needs to first:
- Close out the matter with FDA. This may be demonstrated with an EIR release letter from FDA under FMD-145, a letter from FDA referring all follow-up action to a state Board of Pharmacy, or a status of “closed” on FDA’s Registered Outsourcing Facilities webpage;
- Obtain Drug Distributor Accreditation, if eligible, through NABP; or
- If, prior to applying, a merchant wishes to resolve this eligibility issue, the merchant may email email@example.com to request the option of a Verified Pharmacy Program (VPP) inspection. If NABP Healthcare Merchant Accreditation staff determines, in its sole discretion, that a VPP inspection could resolve this eligibility issue, it may request that the applicant complete a VPP inspection. The VPP inspection report will then be reviewed by NABP Healthcare Merchant Accreditation staff to determine if the pharmacy is eligible to apply for Healthcare Merchant Accreditation. This option is offered solely at NABP’s discretion.
VI. Merchants Subject to an FDA Warning Letter
Where: (1) a merchant or its Affiliate (as that term is defined in the program standards) is subject to an FDA Warning Letter regarding compounding; and (2) that merchant seeks eligibility to apply for Healthcare Merchant Accreditation, the merchant needs to first:
- Hold a “close-out” letter or a status of “closed” on FDA’s Registered Outsourcing Facilities page; or
- Obtain Drug Distributor Accreditation, if eligible, through NABP.
VII. Merchants Offering Online Prescribing Into or From the UK
Where: (1) a merchant and/or its Affiliate(s) (as that term is defined in the program standards) offer online prescribing into or from the UK; and (2) the merchant seeks eligibility to apply for Healthcare Merchant Accreditation:
- The merchant and/or its Affiliate(s) must be registered with the Care Quality Commission (CQC) or its Welsh, Scottish, or Northern Irish equivalent;
- the most recent CQC (or equivalent) inspection must not show significant areas of concern, as determined by NABP in its sole discretion; and
- if a merchant offers to sell human medicines to the public, the merchant must be registered with the General Pharmaceutical Council (GPhC).
- If a merchant located in Northern Ireland sells human medicines to the public via a website, the merchant must display the EU common logo.
VIII. Eligibility after a Prior Denial
Where: (1) a merchant has previously applied for Healthcare Merchant Accreditation and was denied; and (2) the merchant seeks eligibility to apply for Healthcare Merchant Accreditation:
- The merchant must not apply until one (1) calendar year following the date of denial, or one (1) calendar year following the end of the Appeal Process, whichever occurs later, as specified by the Terms and Conditions; and
- After applying, the applicant must demonstrate to NABP’s satisfaction that it has resolved the prior issue(s) resulting in the denial.
A merchant must meet and maintain compliance with the following standards throughout the application process and while accredited.
- Licensure. A merchant must possess all necessary licenses, registrations, and permits in all jurisdictions to which it offers services. This includes not only the jurisdiction where the merchant is located, but also any jurisdiction where its patients or customers reside. All such licenses, registrations, or permits must be valid and in effect.
- Adverse Action. A merchant must not have been subject to significant, recent (within the past 5 years), or repeated Adverse Action.
- Location. A merchant must be domiciled in the US or in a country that has established an understanding with NABP that will allow non-US applicant evaluations to be performed by NABP.
- Validity of Prescription. A merchant shall only prescribe, dispense, or offer to dispense prescription drugs upon the creation of a valid patient practitioner relationship and/or receipt of a valid prescription, as those terms are defined in the applicable jurisdictions.
- Legal Compliance. A merchant must comply with all provisions of Applicable Law.
- Privacy. If a merchant’s website maintains or transmits patient health information, the information must be maintained or transmitted in accordance with jurisdictional patient information privacy and security laws, including those addressing notice to patients regarding privacy and security of such information.
- Contact Information. A merchant must provide on its website up-to-date and responsive contact information. At a minimum, this includes an accurate street address and phone number. Any health care provider must provide a mechanism (either a phone number or secure communication via the internet) that allows patients to contact a health care provider regarding their care.
- Website Transparency. A merchant must not engage in any conduct, or post content on its website, that may deceive, mislead, or defraud its users.
- Domain Name Registration. The domain name registration information of the merchant’s primary website must be accurate, non-anonymized, and have a logical nexus to the merchant.
- Affiliates. A merchant’s Affiliates must comply with all program standards. For purposes of NABP’s Healthcare Merchant Accreditation program, the term “Affiliate” is defined broadly to include any entity that: (i) shares or has shared in the past 12 months ownership with the merchant; or (ii) may be involved, either directly or indirectly, in the merchant’s services. Examples include, but are not limited to:
- An entity that shares or has shared in the past 12 months an Owner, Control, or Management Level Staff with the merchant;
- An entity that shares contact information, such as a phone number or street address, with the merchant;
- An entity that has a formal or informal business relationship with the merchant or its principals;
- Any entity involved in the chain of patient care (eg, downstream fulfillment pharmacies, upstream telemedicine platforms, medical providers); and
- Any website to which the merchant’s website(s) link.
Terms and Conditions
Review the Terms and Conditions before applying.