LegitScript maintains the world’s largest comprehensive database of prescription-only drugs, psychoactive highs, problematic dietary supplements, and other regulated healthcare products, organized by legitimacy and safety. LegitScript monitors and catalogs warnings from over 100 government agencies on an on-going basis and follows regulatory developments in nearly 20 countries around the world.
We take a look at two basic questions: First, what is the product, and second, what is the product’s legitimacy or legal status?
As to the first, we look at whether a product is a prescription or OTC drug, controlled substance, unapproved drug, supplement, psychoactive high, or other miscellaneous healthcare product.
As to legitimacy status, products are classified as follows:
For Red Flag healthcare products, it is important to note that in most cases, if one country’s drug safety authority determines that a particular supplement or other product contains toxins, active pharmaceutical ingredients, or other dangerous substances, it will be equally problematic in all other countries, not merely in the country whose drug safety agency conducted the testing. For example, suppose that the MHRA (the UK’s medicines agency) determines that a weight loss supplement contains undeclared sibutramine, an active pharmaceutical ingredient that is banned in most countries worldwide, including the US, Japan, and throughout the EU. It would not make sense to permit the product to be marketed into any country, since the MHRA is a credible source of information. Accordingly, many of our Red Flag products are problematic globally.
Yes, in certain circumstances. When a government agency finds undeclared ingredients in a dietary supplement, it is up to the manufacturer to obtain confirmation from the government agency that the concerns regarding the product have been remedied. For example, in the US, it is possible to obtain a “close out letter” from the FDA. Another option is to reformulate the product and make clear on the label that it is a different version than that which had been found to contain the undeclared ingredient.
Yes. If you have reformulated your product to remove problematic ingredients, please submit a new label or other evidence that your product has been reformulated. We will replace the Red Flag with a Yellow Flag, and will warn consumers that a previous version contained an impermissible ingredient.
LegitScript’s process takes jurisdictional considerations into account. For example, yohimbine and ginkgo biloba are considered prescription drugs in some countries but are permissible dietary supplement ingredients in others. Accordingly, we classify products containing those ingredients as Red Flag only in the countries where the ingredients are impermissible.
No, not merely by virtue of being Yellow-Flagged. LegitScript’s Yellow Flag classification does not suggest that a product should always be prohibited from advertising, nor does it suggest that the product is intrinsically harmful or dangerous in all cases. It instead means that advertising platforms, e-commerce platforms, and banks should scrutinize these products more carefully, and there are some contexts in which the product cannot be advertised or sold.
Typically, there are three common reasons for a Yellow Flag designation:
No. Products are included in our database when they are currently, or have been previously, impermissibly marketed with problematic claims, have been reformulated, or are unapproved by the FDA but are approved by virtue of being grandfathered or a “DESI” drug.
If the Yellow Flag was based on problematic claims, after you have fully removed all problematic claims from your website and advertisements, we suggest that you contact your advertising account representative to let him or her know that you have brought your website and marketing into compliance. Your account representative may then re-review your website for compliance.
LegitScript also classifies cosmetics as “Red Flag” or “Yellow Flag” based on similar principles as those we use for supplements.
A cosmetic receives a Red Flag designation if it has been found to: (1) be tainted with toxins (e.g., lead or mercury); (2) contain undeclared active pharmaceutical ingredients (e.g., tretinoin or betamethasone); or (3) contain impermissible levels of certain ingredients (e.g., formaldehyde).
LegitScript classifies a cosmetic as Yellow Flag if it is, or has been, marketed in a way that implies: (1) that it is safe or effective to cure, mitigate, prevent, or treat a medical condition (e.g., “treats rosacea”); or (2) that it can affect the structure or function of the body (e.g., “removes wrinkles”), without having been approved as a drug by applicable regulatory authorities. Learn more about Yellow Flags.
In the US, claims that a topical product affects the structure or function of the body cause that product to be considered a drug under the Federal Food, Drug, and Cosmetic Act. If a product is marketed as a drug (by making drug claims), it must comply with all applicable drug laws, including (where necessary) obtaining premarket approval by the FDA before being sold.
In most other jurisdictions, these same claims are considered misleading, and are therefore unlawful.
LegitScript certification helps ensure that you can fully participate in online advertising, e-commerce, and payment processing programs. Some entities — such as Visa, the credit card network — make certification mandatory for pharmacy merchants, with LegitScript one of only two recognized certifiers. Without certification from a recognized entity like LegitScript, many banks, advertising programs, social media platforms, and e-commerce websites will terminate your account.
LegitScript’s robust compliance program helps acquirers avoid fines and/or termination. LegitScript is just one of two certification authorities recognized by Visa, which makes certification mandatory for pharmacy merchants. What’s more, LegitScript continually monitors certified in-scope merchants and helps them to ensure ongoing compliance with emerging regulatory developments.
LegitScript certification is a value-added service for merchants and acquirers alike: LegitScript approval is known throughout the online advertising, social media, regulatory, and payment sectors as an important good-housekeeping seal. It also helps merchants in the highly regulated pharmacy market open doors in these sectors, and keep those doors open.
LegitScript’s program is available to any merchant engaged in selling pharmaceuticals to individuals, whether the sale is online or offline. The Visa requirement pertains to any merchant that may process “card-not-present” payments (i.e., the order is taken over the Internet, over the phone, or in some other remote way). Depending on the circumstance, it may also apply to pharmaceutical merchants selling to other businesses (B2B) or researchers. Contact us if you have questions about whether your business is in scope.
LegitScript’s Internet Pharmacy Certification Program applies to:
Yes. LegitScript pharmacy certification is a global program. Pharmacies in any country may apply, provided that you are adhering to the laws where you operate, and anywhere you offer to ship prescription drugs.
To get certified, simply use our Online Application. But first, you’ll want to collect some materials to make the process easier. You should have handy:
You should also review our Internet pharmacy standards to make sure you meet them. Remember, you have to be operating in accordance with the laws and regulations in all jurisdictions to which you offer to ship drugs.
We want the application process to be as pain-free for pharmacies as possible. Here are a few things that can make the process smoother.
If you have a website, we will not approve an online pharmacy if the WhoIs (registrant) information for the website’s domain name is anonymous or privacy-protected. You can check whether your information is currently privacy-protected at whibse.com. If it is, just contact your domain name registrar and have the privacy protection removed. (This will also save you a little bit of money, in most cases.)
We will not approve an online pharmacy that fills prescriptions solely on the basis of an online questionnaire, unless that practice is legal in all of the jurisdictions to which the online pharmacy provides services.
We do not approve websites sourcing prescription drugs in a way that the FDA or its foreign counterparts has indicated is contrary to law (e.g., “Canadian” or other foreign pharmacy websites shipping into the US, or websites marketing unapproved drugs to Japan, irrespective of pharmacy licenses).
Yes. However, our standard practice is to let you know what areas of non-compliance we found related to our certification standards. If you re-apply within the year, we typically will not charge the one-time application fee again.
We recognize that some merchants may have multiple websites. In these cases, since the merchant is the same, we can lower our prices for the additional URLs. In cases where the content is identical or nearly identical, and the domain name-related information (e.g., the Whois record) is the same, LegitScript charges a substantially lower fee that is about 10% of the fee for the main URL. In cases where the content or the domain name-related information is meaningfully different, we charge a fee that is about 70% of the base fee. Which additional URL fee applies is in LegitScript’s sole discretion.
We look at the totality of the circumstances. Among the factors we may consider are:
These factors may be given differing weights depending upon the overall context.
If you cannot find your answers here, we're happy to help out. Just reach out to us with your questions and we will strive to get back to you quickly.