If you facilitate the sale or prescribing of pharmaceuticals or other regulated healthcare products, or advertise or market healthcare products, some or all of these standards likely apply to you.
- Licensure or Registration
If facilitating prescribing or dispensing, the applicant must only facilitate the dispensing or prescribing of drugs by pharmacies or medical practitioners that are licensed or registered in good standing to operate a pharmacy, or engage in the practice of pharmacy or medicine in all required jurisdictions. This includes the jurisdiction from which the drugs are dispensed or prescribed and the jurisdiction to which the drugs are offered to be shipped and the patient’s jurisdiction, except in circumstances allowed by law.
- Controlled Substances
Laws governing controlled substances vary by country. The applicant must be in compliance with all applicable laws and regulations for controlled substances. For example, any dispensing pharmacy or prescribing practitioner, if dispensing or prescribing controlled substances to US residents, must be registered with the US Drug Enforcement Administration (DEA), and must be in compliance with DEA rules and regulations.
- Prior Discipline
The applicant, including any manufacturer, wholesaler, pharmacy, its pharmacists, and any medical practitioner associated with the website or business must not have been subject to significant recent and/or repeated disciplinary sanctions, warning letters or similar regulatory action.
- Applicant Location
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. Medical practitioners must be domiciled or recognized in the patient’s jurisdiction, unless otherwise expressly permitted as a matter of law.
- 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. A pharmacy must not distribute or offer to distribute, and a practitioner must not prescribe or offer to prescribe, 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.
- Legal Compliance
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. In Japan, this includes the yakujiho (薬事法), and so on. Additionally, the website or business must not facilitate the prescribing or dispensing of, or offer to facilitate the prescribing or dispensing of, medications that have not been approved by the US Food and Drug Administration (FDA) or, as applicable, its counterparts in other countries. 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.
- Patient Services
For applicants with an internet presence, the website must display an accurate street address for any dispensing pharmacy or pharmacies, and the identity and location of medical practitioners engaged in providing medical care or advice to patients. The pharmacy or practitioner must provide an accurate, readily accessible, and responsive phone number or secure mechanism via the website, allowing patients to contact or consult with a pharmacist or practitioner 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 or medical clinic’s corporate headquarters, but only in cases in which the pharmacy or medical business has multiple dispensing pharmacies or outlets, 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 or the public in any way, including but not limited to any material detail regarding the pharmacy, pharmacy staff, medical practitioners, 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 or medical practice. Websites utilizing anonymous domain name registration services will not be eligible for approval. Check your domain name registration at domaintools.com. If your domain name registration information is privacy-protected, contact your domain name registrar.
The pharmacy, business or medical practice, website, staff, any associated medical personnel, domain name registrant, and any person or entity that exercises control over, or participates in, the business must not be affiliated with or control any other entity that violates these standards.