DEA Proposes to Permit the Electronic Transfer of Initial Electronic Prescriptions for Schedules II-V Controlled Substances: Comment Period Ends January 18, 2022

DEA is proposing to amend its regulations to expressly permit the transfer between pharmacies of an initial controlled substance prescription.  Currently, DEA regulations do not address transfer of controlled substance prescriptions — whether paper or electronic — between pharmacies for the initial filling of the prescription.  Historically, if a patient presented a paper prescription to a pharmacy and the pharmacy was unable to fill it, the pharmacist would simply return the prescription paper to the patient and the patient would carry the prescription to a second pharmacy.  There really was no need to “transfer” the paper prescription between pharmacies; paper prescriptions are “portable” by the nature of their paper format.

However, the growing use of electronic prescriptions (DEA notes that more than half of all states mandate electronic prescription opioids, all controls, or all prescriptions) requires DEA to rethink its position on initial prescription transfers.  This is especially important given that the SUPPORT Act of 2018 (section 2003) requires EPCS (with few exceptions) for those prescriptions covered under Medicare Part D beginning in January 2021.

The proposed rule also just makes sense.  More specifically, if a pharmacy receives an electronic prescription for a controlled substance that it cannot fill, the pharmacy simply cannot “return” the prescription (which now is likely an electronic data file) to the patient to take to another pharmacy.  DEA regulations currently do not include any provision for a pharmacy to transfer an EPCS to another pharmacy.  The regulations also do not describe how a pharmacy should handle an EPCS that it receives but cannot fill. At present, a pharmacy that receives an EPCS that it is unable to fill can only notify the patient that the prescription cannot be filled. In this scenario, the patient could then call the prescribing practitioner to request that a new EPCS be sent to a different pharmacy. DEA realizes that this scenario creates the potential for a duplication of prescriptions if, for example, the practitioner transmits a new EPCS to a different pharmacy and does not cancel or void the original EPCS that was sent to the first pharmacy. DEA also recognizes the inability to transfer prescriptions creates an additional burden for patients, who must get back in touch with the original prescribing doctor and request a new prescription.

DEA’s proposal states that, upon request, a registered retail pharmacy may transfer an EPCS in schedules II-V to another registered retail pharmacy for initial filling. This rule will also specify the procedures that retail pharmacies must follow, and the information they must document and maintain when transferring EPCS.

The following recordkeeping requirements will apply to the EPCS transfers:

• The transferring pharmacist must update the patient’s prescription record with the following information: name, address, and DEA registration of the pharmacy to which the prescription was transferred; the pharmacist receiving the transfer; the name of the transferring pharmacist; and the date of the transfer.
• The receiving pharmacist must record the transferring pharmacist’s name, address and DEA registration number, the name of the transferring pharmacist, the date of the transfer, and the name of the pharmacist receiving the transfer.

As with other DEA recordkeeping requirements, the electronic record must be maintained for two years.  DEA estimates that the annual cost savings from the transfer rule would be $22.0 million.  The anticipated savings are based on calculations related to the pharmacists, patients, and prescribers’ time communicating concerning the need to generate and send a new EPCS instead of having the ability to electronically transfer the prescription to another pharmacy.   Comments from industry are due January 18, 2022 (Docket No. DEA-637).