Legislation Would End “Constructive Transfer” and Change CSA Definition of “Dispense” to Permit Pharmacy Delivery of Controlled Substances to Physicians for In-Office Administration

By Karla L. Palmer –

Senators John Cornyn (R-TX) and Sherrod Brown (D-OH) introduced legislation late last week that would allow a pharmacist to dispense a controlled substance prescription for a patient and deliver the drug to a practitioner for administration in the doctor’s office.  S. 2825, titled “Ensuring Safe Access to Prescription Medication Act of 2014,” is designed to amend the Controlled Substances Act (CSA) to treat as “dispensing” the “delivery of a controlled substance by a pharmacy to a practitioner, pursuant to a patient-specific prescription of the practitioner, under certain circumstances.” 

This legislation may seem like nothing more than overly technical change concerning the CSA’s definition of “dispense,” but that's not the case.  For the last 44 years, since passage of the federal CSA, pharmacists have been limited to dispensing controlled substances only to the “ultimate user,” meaning the patient, a member of his or her household, or research subject pursuant to 21 U.S.C. § 802(a)(10) (definition of “dispense”).  The “dispense” definition has proved troublesome for patients, pharmacists and physicians in those cases where controlled substances require in-office administration (e.g., treatment of chronic pain via intrathecal pump, use of testosterone pellets, etc.).  Under the present definition of “dispense,” a pharmacy’s dispensing to anyone other than the ultimate user patient or research subject is illegal.  Physicians, patients and pharmacists have grappled with the ultimate user requirement by creating work-arounds involving agency relationships (e.g., making the physician an agent of the patient, thus permitting dispensing to the doctor per that agency relationship), or creating the fiction of a “constructive transfer” of the controlled substance to the end user through the physician. 

DEA’s position is that such interpretations violate 21 U.S.C. § 802(a)(10)’s definition of “dispense.”  Proponents of the definitional change, however, have long asserted that pharmacy dispensing to the end user, patient or research subject instead of the physician, for certain types of medicine, actually increases the risk of loss and diversion of controlled substances to the extent that time passed between dispensing to the ultimate user and administration of the substance in the doctor’s office.  Moreover, there are safety and efficacy concerns regarding how these medicines are stored and handled until ultimately administered by a practitioner.   

Thus, the legislation would permit a pharmacist to deliver to a doctor’s office a controlled substance for administration under the following conditions:  (1) the delivery is pursuant to a patient specific prescription of the practitioner; and (2) the “practitioner has deemed that it is medically necessary, acting in the usual course of professional practice, for the controlled substance to be administered by the practitioner to the patient.’’

In our view, this legislation is long overdue and will ensure appropriate care without increasing the potential for diversion.