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LegitScript Pharmacy Certification Standards
Pharmacies designated by LegitScript as legitimate are those that have been through the LegitScript certification process and are confirmed to meet LegitScript standards. Certified pharmacies are monitored on an ongoing basis and are subject to full re-review on at least an annual basis.
We require that pharmacies operate in full legal compliance within your jurisdiction, and in any and all jurisdictions to which you offer to ship or dispense drugs.
LegitScript international pharmacy certification standards are:
The applicant must only facilitate the dispensing of drugs by pharmacies that are licensed or registered in good standing to operate a pharmacy, or engage in the practice of pharmacy in all required jurisdictions. This includes the jurisdiction from which the drugs are dispensed and the jurisdiction to which the drugs are offered to be shipped, except in rare circumstances where allowed by law.
Laws governing controlled substances vary by country. The dispensing pharmacy must be in compliance with all applicable laws and regulations for controlled substances.
For example, any dispensing pharmacy, if dispensing controlled substances to US locations, must be registered with the US Drug Enforcement Administration (DEA), and must be in compliance with DEA rules and regulations.
The pharmacy, its pharmacists, and any physician associated with the website must not have been subject to significant recent and/or repeated disciplinary sanctions.
All pharmacies that dispense drugs on behalf of the website must be domiciled in the jurisdiction to which the website offers to ship drugs, except where reciprocity exists, drug importation is expressly permitted as a matter of law, or other legal authority permits or does not require the pharmacy to be domiciled in the jurisdiction.
Validity of Prescription
The applicant or, if applicable, website shall dispense or offer to dispense prescription drugs only upon receipt of a valid prescription, as defined below, issued by a person authorized to prescribe under applicable laws. The pharmacy must not distribute or offer to distribute prescriptions or prescription drugs solely on the basis of an online questionnaire or consultation. Such a method is only valid with a pre-existing patient-prescriber relationship that has included a face-to-face physical examination, except as explicitly permitted under applicable telemedicine laws or regulations.
A valid prescription is one issued pursuant to a legitimate patient-prescriber relationship, which requires the following to have been established: a) The patient has a legitimate medical complaint; b) A face-to-face physical examination adequate to establish the legitimacy of the medical complaint has been performed by the prescribing practitioner, or through a telemedicine practice approved by the appropriate practitioner board; and c) A logical connection exists between the medical complaint, the medical history, and the physical examination and the drug prescribed.
This definition of a valid prescription may be modified upon a showing that the prescribing and dispensing of the drug, as well as the location of the patient, all occur or exist within a jurisdiction that has expressly authorized, by statute, regulation, or other applicable law, alternate requirements for a valid prescription.
The applicant must comply with all provisions of applicable laws.
For the US, this includes but is not limited to state laws and regulations; the Federal Food, Drug, and Cosmetic Act; and the Federal Controlled Substances Act. Additionally, the website must not facilitate the dispensing of, or offer to facilitate the dispensing of, medications that have not been approved by the US Food and Drug Administration (FDA). For countries other than the United States, the website and any dispensing pharmacy must adhere to all applicable pharmacy licensure, drug safety, and supply-chain laws and regulations.
The applicant must adhere to all privacy laws and regulations in the jurisdictions to and from which it offers to ship drugs.
For applicants with an Internet presence, the website must display an accurate street address for the dispensing pharmacy or pharmacies. The pharmacy 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 regarding complaints or concerns, or in the event of a possible adverse event involving their medication.
This requirement may be modified to permit the listing of a pharmacy’s corporate headquarters, but only in cases in which the pharmacy business has multiple dispensing pharmacies, or in cases in which the corporate headquarters’ address is listed with the applicable government agency that licenses and regulates the pharmacy.
None of the applicant’s business practices may engage in practices or extend offers that may deceive or defraud patients in any way, including but not limited to any material detail regarding the pharmacy, pharmacy staff, prescription drugs, or financial transactions.
Domain Name Registration
For applicants with a website, the domain name registration information of the website must be accurate, and the domain name registrant must have a logical nexus to the dispensing pharmacy. Pharmacy websites utilizing anonymous domain name registration services will not be eligible for approval.
Check your domain name registration at whibse.com. If your domain name registration information is privacy-protected, contact your domain name registrar.
The pharmacy, website, pharmacy staff, any associated medical personnel, domain name registrant, and any person or entity that exercises control over, or participates in, the pharmacy business must not be affiliated with or control any other entity that violates these standards.
Did you know?
LegitScript's online pharmacy certification standards as to the US and Canada are recognized by the NABP.
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