Drug importation and cantharidin FAQs
Read answers to frequently asked questions below to learn more about drug importation and cantharidin.
Jump to YCANTH™ cantharidin FAQs
Drug importation FAQs
What is drug importation?
Drug importation is the process of acquiring pharmaceutical products from one country for importation into another for various purposes, such as distribution, sale, or personal use. This practice may involve individuals, clinicians, and pharmacies sourcing medications from international manufacturers to address factors like drug cost, availability, alternative treatments, or to mitigate medical shortages. However, it is important to note that in the United States, the FDA strictly regulates the importation of prescription medications to ensure safety, efficacy, and adherence to regulatory standards.
Can dermatologists import drugs from other countries, such as Canada?
In most circumstances, it is illegal for individuals to import drugs into the U.S. for personal or professional use. This is because foreign-made versions of FDA-approved drugs that have not been evaluated, manufactured, and labeled through the FDA process are typically considered unapproved new drugs and are illegal to distribute. This prohibition applies even if a foreign-made drug is identical or similar to an FDA-approved drug, including drugs that share the same active ingredient and/or are made by the same manufacturer. The FDA does allow the importation of certain foreign drugs for the importer’s personal use. However, dermatologists are unable to obtain pharmaceutical products themselves (personal use) for patient use due to regulations against personal importation of drugs. See FDA guidance on personal importation.
Additionally, there is a pathway for states, tribes, pharmacists, and wholesalers to import drugs from Canada, but this avenue does not extend to individual physicians and other clinicians. Learn more below.
How do states and authorized entities in the U.S. legally import prescription drugs from Canada?
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) amended Section 804 of the Federal Food, Drug, and Cosmetic (FD&C) Act to authorize the HHS Secretary to issue regulations permitting the commercial importation of certain prescription drugs from Canada. On Sept. 25, 2020, HHS and the FDA issued a Final Rule to implement Section 804(b) through (h), which allows FDA-authorized programs to import certain prescription drugs from Canada under specified conditions designed to ensure that the imported drugs pose no additional risk to the public’s health and safety, as well as to provide a “significant reduction” in costs to American consumers.
Notably, the Final Rule does not apply to physicians and other clinicians. The authorized programs must be states or Indian tribes, or upon the FDA’s determination, pharmacists or wholesalers.
Currently, the FDA has only authorized Florida’s state plan (PDF) to import certain prescription drugs from Canada for a 2-year period. Florida's plan specifies the drugs and limits their availability to individuals receiving services through select state agencies and government programs.
View more information on importation program proposals to FDA.
If a drug in need is not available, can dermatologists obtain it through a 503A or a 503B compounding facility, even if an FDA-approved version exists?
According to the FDA, compounding drugs involve customizing medications by combining, mixing, or altering ingredients to meet specific patient needs. Patients may require compounded medications due to allergies to specific drug ingredients or the need for a customized dosage form (e.g., liquid instead of pills) not commercially available. However, dermatologists generally cannot obtain a drug from 503A or 503B compounding pharmacies if it is “essentially a copy” of a commercially available drug or approved drug products. The FDA prohibits this unless specific conditions are met, like a shortage of the approved drug or if the FDA-approved drug isn't available in a needed form, such as a liquid, allowing compounding pharmacies to prepare it.
Detailed information for 503A and 503B facilities is available below:
Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF)
For more information on in-office preparations, access the Academy’s Compounding Tool-kit. To lean about the Academy’s advocacy efforts to address drug shortages , visit the AAD’s drug shortages page. Additionally, you can find information on Current and Resolved Drug Shortages and Discontinuations Reported to FDA.
YCANTH™ (cantharidin) FAQs
What is YCANTH (cantharidin) and what challenges are dermatologists facing with accessing YCANTH?
In 2023, the FDA approved YCANTH (cantharidin) for topical treatment of molluscum contagiosum, a viral skin condition that causes small, raised bumps. This is the first FDA approved drug for the diagnosis molluscum contagiosum. Dermatologists are encountering difficulties in accessibility and affordability of the treatment for patients.
Can dermatologists obtain cantharidin from a 503A or a 503B compounding pharmacy?
No, under FDA rules, compounding pharmacies are prohibited from compounding drugs that are “essentially a copy” of commercially available products unless specific conditions are met, such as a shortage of the approved drug, or if the FDA-approved drug isn't available in a needed form, such as a liquid, allowing compounding pharmacies to prepare it. See above for more information on 503A and 503B facilities.
Can dermatologists import cantharidin from Canada?
Currently, dermatologists are unable to import cantharidin from Canada. In most cases, importing drugs into the U.S. for personal or professional use is illegal. This is because foreign-made versions of FDA-approved drugs, which have not been evaluated, manufactured, or labeled through the FDA process, are generally considered unapproved new drugs and are illegal to distribute. This restriction applies even if the foreign-made drug is identical or similar to an FDA-approved drug, including those with the same active ingredient or produced by the same manufacturer.
What resources are available for patients who are facing denials for molluscum contagiosum treatment?
The AAD Practice Management Center has recently added new prior authorization appeal letters which includes molluscum contagiosum. Authored by prominent dermatologist experts, these letters streamline the PA process and help significantly reduce administrative burden. Access more than 65 other drug letters by visiting.
What is the AADA doing to improve access to cantharidin?
The AADA is actively reaching out to the FDA to advocate for increased access to cantharidin. More specifically, the AADA requested the FDA add cantharidin to its drug shortages list, so compounding pharmacies can continue to compound cantharidin. In addition, the committee also seeks FDA collaboration with manufacturers to increase the availability of approved products. Members will be kept updated on any progress or developments in this area.
How can dermatologists stay informed about developments related to cantharidin access?
Dermatologists should monitor updates from the AADA. Additionally, checking the AAD’s resources and newsletters will provide the latest information on advocacy efforts and access issues.
Who can I reach out to at the AAD with questions?
Contact us with our online form. One of our practice management staff will get back to you within two business days.
This content is for educational purposes only
Please note, the AAD cannot provide legal advice to its members; this information is provided for educational purposes only. Individual physicians must make independent judgments about how to proceed in this area. For specific questions or individual cases, we encourage members to speak with their legal counsel and malpractice carrier.
Additional drug resources
Lidocaine
Lidocaine Shortage: Ask the Expert (DermWorld, January 2023)
Lidocaine Shortage Update (DermWorld, January 2024)
Navigating Drug Shortages: Strategies and Solutions (DermWorld, February 2024)
Cantharidin
AADA urges FDA to increase cantharidin access (Advocacy Update, July 2024)
Prior authorization
Related references
Use our online form to contact practice management staff for questions or concerns.
