DEA proposes to create a new regulation to govern medical missions as well as amend existing to allow practitioners engaged in medical missions to export controlled substances as a coincident activity to the dispensing business activity. DEA has historically granted Medical Mission Waiver Letters, authorizing practitioners to export Schedule II-V controlled substances to a foreign country in furtherance of a medical mission. Because the Controlled Substances Import-Export Act (the non-domestic portion of the CSA) contains specific statutory export requirements that cannot be waived, and because DEA is prohibited from issuing improper guidance, it is necessary to regulate and clarify the application and recordkeeping requirements for medical missions.