PIC QUESTION OF THE WEEK: 7/31/06 Q: Please describe some of the general guidelines for exporting medication to a foreign country for use by an individual patient. A: This topic is quite complicated and compliance with current regulations is dependent on several factors. These include the nature of the product, its status as a controlled substance, the quantity of drug being shipped, compliance with the laws of the country to which the drug is being shipped, its domestic availability in that country, specific state regulations, etc. Exporting medication for individual use must be distinguished from exporting large quantities of drugs by manufacturers and wholesalers. Several states bordering Canada and Mexico permit the direct filling of prescriptions written by physicians in these countries. Most states, however, do not recognize prescriptions written by foreign prescribers. In such cases, the pharmacy serves as a distributor. Unless licensed as an exporter, delivery of medications to a foreign country should be conducted as an exception and not as a rule. Recordkeeping is handled via invoice. In the event of questionable issues, individual circumstances, etc., the pharmacist should consider contacting the FDA, U.S. Postal Service, Drug Enforcement Administration, or specific State Board of Pharmacy. For non-controlled substances, the FDA can provide certification for exportation upon request. Exportation of controlled substances requires a permit from the DEA. The following general guidelines are suggested for the exportation of a prescription drug to a foreign country. • • • • • • •
The pharmacist must receive a prescription from the physician or a letter validating the need for shipping the requested drug The drug should be shipped in the manufacturer’s original container with its labeling intact The original prescription or letter from the physician should be included in the same package as the drug The drug must be shipped directly by the pharmacist to the patient or his/her physician The pharmacist must keep a copy of the original prescription or physician letter and record as an invoice (as if selling directly to a physician) The outer container should include the words medicines and for export If shipped through the mail, the postal service typically places a custom sticker or tag listing the contents on the outer package
Alternatively, pharmacists may contact an export/import agency that deals with the exportation of medications to foreign countries. References: • Reiss BS, Gall GD. Guide to federal pharmacy law, 4th ed. Delma: Apothecary Press; 2005. • Fink (III) JL. Pharmacy law digest, 40th ed. St.Louis: Facts and Comparisons; 2006 John G. Lech, Pharm.D.
Janet K. Astle, RPh.
The PIC Question of the Week is a publication of the Pharmaceutical Information Center, Mylan School of Pharmacy, Duquesne University, Pittsburgh, PA 15282