Under the new regulations, pharmacies can receive, dispense and archive e-prescriptions for drugs and other substances that have a potential for abuse and street use, including opioids, stimulants, depressants, hallucinogens and anabolic steroids. Pharmacies, hospitals and practitioners will also be able to use modern technology for controlled substance prescriptions, while maintaining the closed system of controls on controlled substances dispensing. The program will reduce paperwork and may reduce the number of prescription errors, according to the release.
Other improvements to the regulations include the following:
- Allowing one of the factors in the required two-factor authentication to be a biometric.
- Identity proofing can be by institution or third-party certification authorities.
- More leeway on how the prescription is written.
- Auditing of vendors has been changed to every two years.
- Record retention was changed to two years, which is parallel to the requirement for paper prescriptions.
- Removal of the requirement for storage of back-up records at another location.
- Monthly logs will still be required, but mandatory review by the practitioner will not be required.
- Vendors do not need to compare users to the DEA list. Rather, prescribers are responsible for knowing if they can legally write controlled drugs; this also applies to paper prescriptions.
The effective date of this regulation is June 1. Comments to the DEA are also due by June 1, according to the release.
Read the AGA’s release on e-prescribing of controlled substances.
