On August 28, 2023, amendments to Drug Enforcement Agency (DEA) regulation 21 CFR 1306.08 will go into effect, which amend the regulations allowing the transfer of initial electronic prescriptions for schedule II-V controlled substances between registered retail pharmacies. The DEA issued a Final Rule on July 27, responding to comments related to the amendments (88 Federal Register 48365), which will result in new subsections (e)-(i) of 21 CFR 1306.08.
The amended regulations are intended to make it easier for patients whose initial electronic prescription for controlled substances (EPCS) was sent to a pharmacy that cannot fill the prescription. The regulations will permit, upon request by the patient, a one-time transfer of the prescription to another retail pharmacy designated by the patient without requiring the patient to receive a new prescription from their provider. Although current DEA regulations address the transfer of existing refills for prescriptions for schedule III-V controlled substances, they do not address what patients can do if a pharmacy cannot fill an initial prescription.
The One-Time Transfer Process Explained
Under the amended regulations, a one-time transfer of an initial EPCS is permitted upon request from the patient. The patient request must include a designation of the pharmacy to which the prescription will be transferred. The Final Rule clarifies a transferring pharmacy is not required to maintain documentation of the patient’s request to transfer. Nonetheless, to the extent that it can be efficiently documented, it is advisable for transferring pharmacies to document that the transfer and the selection of the receiving pharmacy were made at the patient’s request.
The DEA noted that, practically speaking, the pharmacy receiving the transfer will have to “request” it electronically if using the SCRIPT Standard Version 2017071 or some other electronic platform. In the Final Rule, the DEA also clarified any authorized refills of schedule III-V controlled substances are transferred with the initial EPCS and that such transfer still constitutes a “one-time” transfer. Due to this “one-time only” limitation, blanket requests to transfer “all prescriptions” would not be permissible. The patient must request a transfer on a prescription-by-prescription basis.
The amended regulations also state that “[t]he prescription must be transferred from one retail pharmacy to another retail pharmacy in its electronic form. At no time may an intermediary convert an electronic prescription to another form (e.g., facsimile) for transmission.” DEA prohibits the conversion of the EPCS into written form to reduce the likelihood of duplicate prescriptions that could lead to diversion or misuse. While the amended regulations clearly state that the EPCS must remain in its “electronic form,” the amended regulations do not specify by what electronic means the prescription must be transferred. However, the Final Rule does point out that the Centers for Medicare & Medicaid Services (CMS) adopted SCRIPT Standard Version 2017071 as the official electronic prescribing standard for prescriptions covered under Medicare Part D; and since SCRIPT Standard Version 2017071 is widely available to both independent and chain pharmacies, it presents a very viable method of electronic transfer of EPCS between even unaffiliated pharmacies.
Responsibilities of Transferring and Receiving Pharmacies for EPCS Transfer
Out of concern that a transferred EPCS could be misused, DEA has made clear that both the transferring and receiving pharmacy have a corresponding responsibility regarding the filling and proper documentation of any transferred EPCS. Upon transfer, the transferring pharmacist must ensure that the electronic prescription record indicates the following:
- That the prescription has been transferred.
- The name, address, and registration number of the receiving pharmacy and the name of the receiving pharmacist.
- The name of the transferring pharmacist and the date of transfer.
Likewise, upon receipt, the receiving pharmacist is required to do the following:
- Add the word “transfer” to the prescription.
- Annotate the name, address, and registration number of the transferring pharmacy and the name of the transferring pharmacist.
- Record the receiving pharmacist’s name and transfer date.
Both pharmacists must ensure that none of the required contents are altered, truncated, or removed during the transferal process, and all records related to the transfer must be maintained for two years (notwithstanding any state record retention requirements that may go beyond two years).
Providers Must Balance Patient Convenience and Regulatory Safeguards
This process is required for any transfer of initial EPCS between separate registrants, even if the same parent entity owns the two registrants. While the Final Rule states that any transfers under the amended regulations “must be communicated directly between two licensed pharmacists,” DEA clarified that the term “pharmacist” is defined broadly to include “any other person (e.g., pharmacist intern) authorized by a State to dispense controlled substances under the supervision of a pharmacist licensed by such State.” Similarly, although DEA permits this transferal process under its regulations, it limits the transfer of EPCS only “if allowable under existing State or other applicable law.”
DEA’s amended regulations will undoubtedly lighten the burden on patients seeking to fill their EPCSs. The amendments reflect a world in which paper prescriptions are no longer the norm, and a pharmacist handing the patient a paper prescription when transfer is necessary is no longer a viable solution. However, the benefit to the patient in allowing the one-time transfer of EPCSs must be balanced with significant safeguards to discourage potential diversion or misuse from duplicate prescriptions. Doing so will significantly shift the burden in this process from patients to pharmacies, as both pharmacies engaged in the transfers of EPCSs will be required to take on the responsibility to ensure all additional record-keeping requirements are met while the receiving pharmacies must retain corresponding responsibility for the filling of all transferred EPCSs.
The Bass, Berry & Sims healthcare practice has significant experience advising clients on compliance with the Controlled Substances Act and DEA regulations and stands ready to help pharmacies as they navigate these new practices and requirements.