Controlled substances: Bipartisan team introduces new legislation

Senators Brown (D-OH) and Cornyn (R-TX) recently introduced S. 2825, the Ensuring Safe Access to Prescription Medication Act. The bill would amend the Controlled Substances Act (CSA) to permit constructive transfers of controlled substances from pharmacies to prescribing practitioners, including physicians and veterinarians, on behalf of the ultimate user. Under the CSA, an ultimate user may be a patient, an animal’s owner, or a member of the patient’s or owner’s household.

Define the terms

For years, pharmacies have raised concerns with the way the Drug Enforcement Administration (DEA) has interpreted the CSA’s definitions of “dispense,” “distribute,” and “deliver” or “delivery” in the context of constructive transfers.

According to the DEA argument,

• The transfer of a controlled substance from a pharmacy to anyone (including a prescribing practitioner) is distribution, not dispensing to the ultimate user

• Compounding for distribution is manufacturing

From a pharmacy’s perspective, this interpretation is problematic, because distribution is outside the scope of a pharmacy’s DEA registration status as a practitioner, and registration as a manufacturer is also required.

In addition, to dispense a controlled substance to a patient instead of to the doctor may increase the risk of diversion and create safety concerns for handling of sterile drugs prior to their injection or administration by the prescriber.

Changes sought

Recent efforts to change the DEA’s position can be traced to a 2007 federal appellate court decision.

In Wedgewood Village Pharmacy v. DEA, the U.S. Court of Appeals for the D.C. Circuit sharply criticized the DEA’s restrictive interpretation of constructive transfers. The court found the DEA’s interpretation to be in conflict with dictionary and statutory definitions, as well as with the DEA’s own regulations.

After the court decision, which stated that the DEA should address the issue of constructive transfers, the DEA and the pharmacy reached a settlement agreement. The settlement allowed the DEA to maintain its legal position on constructive transfers to the present day.

Members of Congress have introduced legislative fixes and requested that the DEA solicit input through a rulemaking on the topic of constructive transfers.

Bills introduced in earlier Congresses would have permitted the delivery from pharmacies to prescribing practitioners of controlled substances administered through the use of intrathecal pumps. Unlike those bills, S. 2825 does not limit the types of controlled substances that could be delivered from a pharmacy to a prescribing practitioner.

What would change

If S. 2825 becomes law, it will force the DEA to change its determination that transfers of controlled substances to prescribing practitioners, as opposed to the ultimate users, are distributions of controlled substances. The bill would amend the CSA definition of “dispense” to include the delivery of a controlled substance by a pharmacy to a prescribing practitioner.

The proposed legislation would permit pharmacies to provide the necessary packaging, labeling, and compounding required for delivery of the controlled substance to a prescribing practitioner.

The bill also would necessitate the DEA’s review of its position that compounding of controlled substances by pharmacies for delivery to prescribing practitioners is manufacturing under the CSA.

S. 2825 mandates that delivery be conducted pursuant to the practitioner’s issuance of a patient-specific prescription. In addition, the prescribing practitioner must deem it medically necessary, in the usual course of professional practice, for the controlled substance to be administered by the practitioner to the patient. Finally, the bill would remove the current requirement that controlled substances be dispensed only to the ultimate user or research subject.

Unless S. 2825 sees floor action in the next few weeks, it must be reintroduced at the start of the 114th Congress in January 2015.