Program Eligibility and Policies
Eligibility Requirements and Program Policies
The .Pharmacy Verified Websites Program application process includes vetting by NABP, prior to approval of domain registration, to ensure that applicants meet all applicable Program Standards, which also address regulatory standards including pharmacy licensure and valid prescription requirements. 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 conduct business including, without limitation, dispensing or shipping prescription medications in or to a jurisdiction.
The following requirements must be met to be eligible to apply for and register a .pharmacy domain name, unless NABP, at its sole discretion, grants a waiver.
I. Types of Organizations that May Apply
The following types of organizations may apply for approval to register a .pharmacy domain name if they offer prescription drugs or prescription drug-related products, services, or information via the internet:
- Human Pharmacy
- Veterinary Pharmacy
- Pharmacy Benefit Management Company
- School or College of Pharmacy
- Continuing Pharmacy Education Provider
- Wholesale Drug Distributor
- Pharmaceutical Manufacturer
- Advocacy or Consumer Education Group
- Drug Information or Pharmacy Referral Site
- Pharmacy Association
- Medical Professionals Sites
- Pharmacy Consultant
- Pharmacy Automation Distributors
- Board of Pharmacy and Regulatory Agency
II. Compliance with Program Standards
Applicants must meet the Program Standards:
- At the time the applicant submits its .Pharmacy application;
- While the application is pending; and
- If the application is approved, during the domain registration process.
Once registered, Registrants must comply with the Program Standards.
III. Compliance with Terms and Conditions
Applicants and Registrants must comply with the Terms and Conditions.
IV. Drug Distributor Accreditation Required for Wholesale Drug Distributors or Organizations that Provide Drug Distribution Services
If licensed as a wholesale drug distributor or if engaged in drug distribution services, the organization must first be accredited through NABP’s Drug Distributor accreditation program to be eligible for the .Pharmacy Verified Websites Program. This requirement enables NABP to ensure compliance with all applicable laws. Eligibility for the .pharmacy program will typically require Drug Distributor accreditation for all such facilities; however, NABP may exercise discretion regarding which facilities will be required to have Drug Distributor accreditation as a prerequisite for approval to register a .pharmacy domain.
V. Organizations Subject to a Food and Drug Administration (FDA) Form 483 Notification
Where: (1) an organization or its affiliate is subject to a Form 483 Notification; and (2) that organization seeks eligibility to apply for and register a .pharmacy domain name, the organization needs to:
- 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 requested by NABP, complete a Verified Pharmacy Program (VPP) inspection, which will be reviewed by NABP .Pharmacy Program Staff to determine if the pharmacy currently complies with .Pharmacy Program standards.
VI. Organizations Subject to an FDA Warning Letter
Where: (1) an organization or its affiliate is subject to an FDA Warning Letter; and (2) that organization seeks eligibility to apply for and register a .pharmacy domain name, the organization needs to:
- 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. Organizations Offering Online Prescribing Into or From the UK
Where: (1) an organization and/or its affiliate(s) offer online prescribing into or from the UK; and (2) the organization seeks eligibility to apply for and register a .pharmacy domain name:
- the organization 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 the organization offers to sell human medicines to the public, the organization must be registered with the MHRA, be included in the MHRA’s list of UK registered online retail sellers, and display the EU common logo.
The Program Standards that applicants must meet to be eligible to apply for and register a .pharmacy domain name follow:
- Licensure. An applicant, as well as community members to which the applicant site links or with which it is affiliated, must possess all necessary licenses, registrations, or permits to practice in all required jurisdictions. This includes not only the jurisdiction where the entity is located, but also any jurisdiction where its patients or customers reside. All such licenses, registrations, or permits must be in good standing.
- Prior discipline. An applicant, as well as any community members to which the applicant site links or with which it is affiliated, must not have been subject to significant recent and/or repeated disciplinary sanctions.
- Location. An applicant, as well as community members to which the applicant site links or with which it is affiliated, must be domiciled in the US or in a country with a .pharmacy National Standard Setting Committee, or in a country that has established an understanding with NABP that will allow non-US .pharmacy applicant evaluations to be performed by NABP.
- Validity of prescription. A pharmacy shall dispense or offer to dispense prescription drugs only upon receipt of a valid prescription, as defined by the applicable jurisdictions. A valid prescription is one issued pursuant to a legitimate patient-prescriber relationship, as defined by the applicable jurisdictions.
- Legal compliance. An applicant, as well as community members to which the applicant site links or with which it is affiliated, must comply with all provisions of jurisdictional law, including laws addressing regulatory agency approval of prescription medication.
- Privacy. If the applicant website, or any site to which the applicant site links or with which it is affiliated, 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.
- Patient services. An applicant pharmacy, medical or veterinary practice, medical or veterinary practitioner, or any such practice or practitioner to which the applicant site links or with which it is affiliated, must provide on the website an accurate street address of the dispensing pharmacy, medical practice, medical practitioner, or corporate headquarters. The applicant pharmacy, medical practice, medical practitioner, or any such practice or practitioner to which the applicant site links or with which it is affiliated, must provide on the website an accurate, readily accessible and responsive phone number or secure mechanism via the website, allowing patients to contact or consult with a pharmacist or medical practitioner regarding complaints or concerns or in the event of a possible adverse event involving their medication.
- Website transparency. An applicant, as well as community members to which the applicant site links or with which it is affiliated, must not engage in practices or extend offers on its website that may deceive or defraud patients as to any material detail regarding the practice, its staff, prescription drugs, or financial transactions.
- Domain name registration. The domain name registration information of the applicant website, or of any community member it promotes, must be accurate, and the domain name registrant must have a logical nexus to the dispensing pharmacy, medical or veterinary practice, or medical or veterinary practitioner. Applicant websites utilizing anonymous domain name registration services will not be eligible for approval.
- Affiliates*. The applicant website, any community member it promotes, its staff, domain name registrants, and any person or entity that exercises control over, or participates in the applicant business, must not be affiliated with or control any other website that violates these standards.A non-pharmacy applicant that affiliates with pharmacies or prescription drug wholesale distributors must affiliate only with pharmacies or prescription drug wholesale distributors that are accredited or approved by the NABP .Pharmacy, Digital Pharmacy, DMEPOS or Drug Distributor programs or, if the affiliate is a pharmacy, it has received a favorable inspection by the NABP VPP program within the 12 months prior to the date the .pharmacy application is submitted. NABP may use its discretion in determining whether an applicant must meet this element of the standard.*An “affiliate,” in this context, includes without limitation, any website to which the applicant website links, as well as other entities that share or have shared in the past 12 months a common ownership or common principals, management, pharmacist in charge, or shared contact information such as a phone number or street address with the applicant entity.
Terms and Conditions
Review the Terms and Conditions before applying.
- NABP may require applicants, or registrants holding a .pharmacy domain, to successfully complete an onsite inspection of the entity’s physical location(s) to demonstrate compliance with applicable law or Program Standards. Based on the business model, NABP will exercise its sole discretion in determining the NABP program that will conduct the inspection of the applicant’s physical location(s). The applicant or Registrant is responsible for all costs and fees associated with the inspection, which will be charged in addition to the .pharmacy application and domain name registration fees.
- NABP Reservation of Rights
Pharmacy-related organizations, their business models, and operations continue to evolve. Some business models are novel or unique and may require additional information or verifications for NABP to validate compliance with .pharmacy program standards. Accordingly, NABP reserves the following rights in operating the .Pharmacy program:
- NABP is the sole decision-maker in connection with the .pharmacy domain.
- NABP may require applicants or Registrants holding a .pharmacy domain to timely provide additional information, documentation, explanation or to demonstrate compliance with applicable law or Program Standards. For example, NABP may request to review the following documentation or operations including, without limitation:
- Policies and procedures; customer, vendor, or affiliates lists; drug acquisition or sale documents;
- On-site survey of the organization and its operations as set forth in paragraph 1, above;
(Applicants and Registrants holding a .pharmacy domain will be notified of any additional fees associated with the review or survey.)
- NABP may draw conclusions from evidence that is provided or available to it when evaluating an application or a Registrant’s participation in the .pharmacy program, including without limitation, affiliates within the last 12 months prior to the application date, or regulatory actions, sanctions, or disciplines within the last five years prior to the application date.
To learn more about the program, please read the following documents.
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.Pharmacy Program Oversight
The .Pharmacy Verified Websites Program is overseen by an executive board that operates under the principles outlined in the NABP .pharmacy governance document. The executive board is made up of pharmacy, regulatory, and digital experts from around the world.
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