Magazine article Drug Topics

Controlled Substances: Bipartisan Team Introduces New Legislation

Magazine article Drug Topics

Controlled Substances: Bipartisan Team Introduces New Legislation

Article excerpt

LEGAL COMPLIANCE

Senators Brown and Comyn spearhead changes to CSA

Senators Sherrod Brown (D-Oh) and John Comyn (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. …

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