The telehealth business model is here to stay but online pharmacies require this one thing to be legally compliant...
One positive effect of the COVID-19 pandemic was the technological advancements made to keep patients and their healthcare providers connected. CMS and State Boards of Pharmacy relaxed many restrictions on telehealth and online pharmacies. It is expected that governmental acceptance of telemedicine and online pharmacies will continue post-pandemic.
How to Know if an Online Pharmacy is Legitimate
Online pharmacies that wish to be reputable, maintain quality operations, and regulatory compliance will need to seek accreditation from either NABP .Pharmacy or LegitScript to be certified. NABP allows accredited pharmacies to bear the .Pharmacy domain, signifying to the public that the online pharmacy is legitimate. The .Pharmacy domain additionally automatically permits pharmacies to advertise with Google, Yahoo!, Twitter, etc. Mastercard and Visa will also designate an accredited pharmacy as a legitimate merchant and allow for “card-not-present” transactions.
What About Compounding Pharmacies?
For compounders, accreditation of an online pharmacy may be extremely difficult to attain. For instance, if the compounding pharmacy has received a FDA Form 483 or FDA Warning Letter, accreditation will likely be denied. Despite the NABP acknowledgement that the FDA Form 483 “is not a citation or notice of violation of any law or rule,” facilities seeking NABP .Pharmacy accreditation may be denied if a FDA Form 483 or Warning Letter is still open. As such, pharmacies seeking eligibility to apply for a .Pharmacy domain name that have an open 483 or Warning Letter need to:
Obtain a “close-out” letter or a status of “Closed” on the FDA’s Registered Outsourcing Facilities page (applicable for 503Bs);
Obtain Drug Distributor accreditation, (applicable for wholesale drug distributors, 3PLs, drug manufacturers, 503Bs, etc.) through the NABP; or
If requested by the NABP, complete a Verified Pharmacy Program (“VPP”) inspection to demonstrate that the pharmacy complies with all NABP .Pharmacy Standards.
Unfortunately FDA 483s and Warning Letters tend to take a long time to close out (often times a year or longer). The best advice for pharmacies is to avoid them altogether by abiding by the Federal Food Drug and Cosmetic (FD&C) Act Section 503A and preventing the presence of insanitary conditions.
NABP Compounding Accreditation vs. NABP .Pharmacy Accreditation
The NABP Compounding Pharmacy Accreditation is available to compounding pharmacies that demonstrate they:
Compound prescriptions mainly for humans (not animals);
Compound patient-specific preparations pursuant to prescriptions (are not a 503B outsourcing facility);
Comply with the FD&C Act section 503A;
Meet USP minimum standards for compounding; and
Have passed the NABP Verified Pharmacy Program (VPP) inspection.
Conversely, a NABP .Pharmacy accreditation can be obtained by various entities that offer prescription drugs or prescription drug-related products, services, or information via the internet (e.g., pharmacies, drug wholesalers, pharmaceutical manufacturers, PBMs, etc.), not just compounding pharmacies.
Is it Easier to Obtain Accreditation from LegitScript?
LegitScript is an accreditation agency that provides compliance and monitoring services for health care product suppliers and online pharmacies. They accredit health care merchants, pharmacies, telemedicine providers, eyewear merchants, and addiction treatment providers. LegitScript accreditation is required by many companies before a pharmacy may become a participating member. Certain credit card companies (e.g., Visa, Mastercard) require certification for all pharmacy merchants. While there is no defined language that LegitScript could deny a compounding pharmacy accreditation based on a FDA Form 483 or Warning Letter, they do state it is their “sole discretion,” to “grant, deny, or revoke Applicant’s certification application or certification status for any reason and at any time.“ Further, LegitScript likely sees 483s and Warning Letters as Disciplinary Actions, which are expected to affect their decision.