News, Views & Reviews: Importing Injectables

The product does not display a National Drug Code (NDC) number.^b

The lot numbers and expiration dates on the carton do not match those on labels of the containers included in the carton.

The medication was not shipped under conditions that satisfy labeled storage requirements. For example, if the medication is labeled to require refrigeration, it was not shipped with cold packs or other measures to ensure temperature control.

^aFDA has compiled website links or contact information to state agencies responsible for licensing of wholesale prescription drug distributors on their website at: http://www.fda. gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ ucm281446.htm .

^b Inclusion of an NDC number on the label is not required, nor does it denote FDA approval of the product. However, the absence of an NDC on the label may suggest that the product was not originally manufactured for the US market, and that in turn may suggest that it may not comply with US requirements.

Additionally, if you suspect that product that you have purchased and/or used may not be legitimate, either through appearance or by unexpected adverse events, it is critical that FDA is notified.

Health care professionals and patients can report suspect solicitations, and questionable sources and products to FDA through the following methods:

Call FDA’s Office of Criminal Investigations (OCI) at 800- 551-3989, or

Report to OCI at www.accessdata.fda.gov/scripts/email/oc/ oci/contact.cfm, or

Email - DrugSupplyChainIntegrity@fda.hhs.gov

Further, healthcare providers and patients are asked to report adverse events related to the use of suspect medications to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone by:

Completing and submitting the report online: www.fda. gov/MedWatch/report.htm or

Downloading form at: http://www.fda.gov/downloads/ Safety/MedWatch/HowToReport/DownloadForms/ ucm082725.pdf, or

Calling 1-800-332-1088 to request a reporting form, then completing and returning it to the address on the pre-addressed form, or submitting by fax to 1-800-FDA-0178.

So when a patient comes to you waving coupons, ads, or otherwise demanding a better price than is reasonable for authentic product, what can you say? First, it is incumbent upon you to explain that one gets what one pays for. If the patient wants the cheapest injection, try to make them understand that this is a mistake and they could be harmed. You can explain clearly and simply that you are a trained and accredited professional, and that you would not inject them with anything but the product that FDA has reviewed and approved as safe and effective for its intended use. Emphasize your training and accreditation. Let your patients know that you are uniquely positioned through your education and training to work with them individually (not a one-injectionfits- all shop), and educate them as to the meaning of using authentic, FDA-approved product. They are most likely unaware that prescription drugs from unlicensed or foreign suppliers may be counterfeit, and/or may be drugs from foreign or unknown sources that are not approved for distribution in the United States. They may not understand that these drugs may have unknown ingredients, and may not have been manufactured, transported or stored under proper conditions as required by US law and regulations. They also may not realize that importing foreign, non-FDA-approved products when there is an FDA-approved drug available is illegal, and could be dangerous to them. You don’t want to put your patients in harms way by skirting the regulatory system, which is put in place to protect patients from unsafe, ineffective, and potentially dangerous drugs. Remind your patients that they want be able to put a proud face forward, and not risk the losing face by wearing the results of shoddy procedures, untrained efforts, or fake medicines.

The authors have not disclosed any relevant conflicts of interest.

Kenneth Beer MD PA
Beer General, Surgical, and Esthetic Dermatology,
West Palm Beach, FL

Perelman School of Medicine, University of Pennsylvania,
Philadelphia, PA



Karen Rothschild JD
Regulatory Counsel, Food and Drug Administration
Washington DC

^aFDA has compiled website links or contact information to state agencies responsible for licensing of wholesale prescription drug distributors on their website at: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ ucm281446.htm .

^b Inclusion of an NDC number on the label is not required, nor does it denote FDA approval of the product. However, the absence of an NDC on the label may suggest that the product was not originally manufactured for the U.S. market, and that in turn may suggest that it may not comply with U.S. requirements.