Update: Electronic Prescriptions – Controlled Dangerous Substances December 21, 2021
Health care practitioners must apply for a waiver by January 1, 2022. Compliance actions will be delayed until January 1, 2023.
To apply for a waiver, visit the Office of Controlled Substances website, Quick Links,
Electronic Prescribing Waiver Request.Effective January 1, 2022,
Senate Bill 0166 (CH0299)/House Bill 0512 (CH0230) (2020) Drugs and Devices – Electronic Prescriptions – Controlled Dangerous Substances.
requires licensed health care providers to electronically prescribe prescriptions for controlled dangerous substances and allows for waivers to be granted under certain circumstances. The effective date of the state law aligned with the comparable federal law (Section 2003 of the SUPPORT Act). In December 2020, Centers for Medicare and Medicaid Services (CMS) implemented the first phase of this mandate by naming the standard that prescribers must use for e-prescribing transmissions and delaying compliance actions until January 1, 2022.
On November 2, 2021,
CMS announced they are delaying the start date for compliance actions to January 1, 2023, in response to stakeholder feedback. In order to maintain alignment with the federal government, MDH is also delaying compliance actions to January 1, 2023
However, to maintain compliance with Health General Article, 21-220(C) which requires implementation of e-prescribing on January 1, 2022 , a health care practitioner who is unable to electronically transmit prescriptions for controlled dangerous substance drugs must request a
waiver from the electronic prescribing requirement. All requested waivers will be granted for calendar year 2022 only.
Update: Suspension of disciplinary actions - Epidiolex December 22, 2021
Purpose – The purpose of this statement is to provide clarification to Maryland
pharmacists, pharmacies and other licensees dealing with patient prescriptions
for Epidiolex on or after December 22, 2021.
As a result of actions under the federal Agriculture Improvement Act (AIA), the
drug Epidiolex was descheduled under the federal Uniform Controlled
Substances Act (CSA). On August 21, 2020, the U.S. Drug Enforcement
Administration (DEA) issued an Interim Final Rule incorporating the AIA into DEA
regulations officially removing any federal controlled substance designation from
the prescribing and dispensing of the drug, Epidiolex. Following descheduling by
Congress, the FDA approved the drug’s revised non-scheduled label. The FDA’s
National Drug Code directory also shows the current status of the drug as
non-scheduled. Accordingly, pursuant to the AIA, Epidiolex is not a controlled
substance under the CSA and is therefore no longer subject to the CSA and its
implementing regulations.
The Maryland Uniform Controlled Substances Act still lists the drug’s ingredient
as a Schedule V controlled substance (See, MD Code Ann. Crim. Law §5-406(f))
and cannot be updated until the 2022 legislative session, as such this has
created a temporary conflict between federal and state law. In order to maintain
alignment with the federal government, until the Maryland Legislature can take
action to deschedule Epidiolex, MDH will exercise its regulatory discretion.
Effective December 22, 2021, MDH and the Office of Controlled Substance
Administration will no longer pursue disciplinary action against licensees or
registrants that appropriately receive, process, and dispense Epidiolex
prescriptions as a non-controlled drug.
