Every week, IACP members contact our offices for questions about practice, business, legislation and other issues. Beginning with this issue of Capitol Connections, we'll highlight a question we've been asked that affects many of our members. If you have a question you'd like answered, send that to email@example.com
This week's question comes from an IACP member regarding international shipments.
Question: Can I ship a compounded preparation to a physician or patient in another country?
Answer: The distribution of prescription drugs internationally is extremely complex. It involves both exportation and importation laws, licensure requirements in both the pharmacy's home state and potentially professional or business permits in the country of receipt, and potential impact on accreditation status.
The Food and Drug Administration, along with the US Customs Service, has federal authority over both importation of drugs into the US as well as exportation of drugs from the US. The Federal Food, Drug, and Cosmetic Act prohibits the interstate shipment -- which includes importation and exportation -- of unapproved new drugs. Thus, the importation of new drugs that lack FDA approval, whether for personal use or otherwise, violates the Act. Similarly, exportation of unapproved new drugs is also prohibited. Unapproved new drugs include any drugs--including foreign-made versions of U.S. approved drugs--that have not been manufactured in accordance with FDA approval. The FDA considers all compounded medications to be unapproved new drugs and therefore would consider the exportation or shipment of either a patient-specific or an office-use compounded preparation to be a violation of the FDCA. Additional details on the rules regarding exportation, including registration, permits, and other FDA requirements, is detailed in Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996.
The country to which the compounded preparation is being shipped may also impose importation requirements including registration, fees, permits and in some countries the availability or accessibility of an in-country agent to which regulatory authorities may turn if there are questions or concerns. Each country's laws and regulations vary and would need to be reviewed in detail by the pharmacist and the pharmacist's attorney before proceeding.
Additionally, some state Boards of Pharmacy regulations and rules may deem international shipment to exceed the scope of pharmacy practice inasmuch as such an activity would prevent the pharmacist from exercising his or her due diligence in assuring appropriate patient profiles, counseling, and other responsibilities. A pharmacy considering international practice and trade should consult with the Board in which they hold their primary license in order to determine if such an activity is even possible.
Accreditation standards from at least one pharmacy compounding accreditation body specifically address international dispensing of compounded preparations. Those standards are written so as to prevent or revoke accreditation for a pharmacy engaged in out-of-country dispensing or sales.