Whether a business is eligible, and which certification category it belongs in, is settled before a single document is written, and a business that files under the wrong one has bought a review of something it is not. These articles explain the eligibility rules and the category definitions in the terms a reviewer applies them.
Eligibility and certification categories
An open regulatory action, a board complaint, a previous merchant termination or a warning letter attached to a principal is rarely what ends a LegitScript application, and concealing one reliably is, because the record is discoverable and being found converts a fact into a credibility problem.
· 5 min read
Eligibility and certification categories
Mental health and substance use treatment delivered remotely combines controlled substances in some models, a patient population in crisis and confidentiality rules that go beyond HIPAA, which makes it the category where a LegitScript reviewer expects clinical governance to be documented rather than described.
· 5 min read
Eligibility and certification categories
A telehealth catalogue containing a laboratory panel or a home test kit adds four questions to a LegitScript application that a medicines-only file never faces: which laboratory runs it, who is licensed to order it, who interprets the result, and what the marketing promises the number means.
· 5 min read
Eligibility and certification categories
A supplement sold in the same cart, the same bundle and the same brand voice as a prescription medicine tends to read as making a disease claim by association, which turns a low-risk product line into the part of a LegitScript application that needs explaining.
· 5 min read
Eligibility and certification categories
A LegitScript certification attaches to a website rather than to a company, so a telehealth platform serving twenty clinics has to answer a question its architecture never asked: whether the patient transacts on the platform's domain or on the clinic's, because that decides who the applicant is.
· 5 min read
Eligibility and certification categories
A LegitScript application is reviewed against the business the applicant describes, so a telehealth company that files as a pharmacy, or a marketplace that files as a clinic, has bought a review of something it is not and will spend a round trip discovering it.
· 5 min read
Eligibility and certification categories
A telehealth business incorporated outside the United States can hold LegitScript certification, but the review follows the patient rather than the company, so what decides the application is where patients are, where prescribers are licensed and where the medicine ships from.
· 5 min read
Eligibility and certification categories
Prescribing controlled substances via telemedicine is not automatically disqualifying for LegitScript certification, but it moves the application into a category where the reviewer expects a documented framework rather than an explanation.
· 5 min read
Eligibility and certification categories
Selling compounded medicines does not make a telehealth business ineligible for LegitScript certification, but it does move the application into the category where the largest number of FDA warning letters in this sector have been issued, nearly all of them over how the product was described.
· 5 min read
Eligibility and certification categories
A 503A pharmacy compounds for an identified individual patient pursuant to a prescription while a 503B outsourcing facility registers with the FDA and may produce in bulk under manufacturing standards, and telehealth brands routinely describe their partner as the wrong one.
· 5 min read