DEA Guidance on Changing Controlled Substance Prescriptions

On August 22 2022, ALBOP received the following guidance from DEA:

“In the past few months, DEA has received an increasing number of questions concerning pharmacists’ ability to add or modify information—like a patient’s address—on paper prescriptions. To address these questions, DEA has been reviewing the relevant regulations and working to draft new regulations to address this issue. As an interim measure, pharmacists are permitted to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.

Pharmacist Prescribing of Paxlovid

On July 6, 2022, in a letter to Pfizer, Inc from the FDA, the FDA has now concluded that a pharmacist may prescribe Paxlovid only pursuant to strict compliance to certain conditions.  While it is your responsibility to read and understand the entirety of the referenced letter, the Board directs your specific attention to the following portions appearing on page 4 of the letter.

  • PAXLOVID may also be prescribed for an individual patient by a state-licensed pharmacist under the following conditions: 
    • Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider-patient relationship with the individual patient, to assess renal and hepatic function; and 
    • Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established provider-patient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and nonprescribed) that the patient is taking to assess for potential drug interaction. 
  • The use of PAXLOVID covered by this authorization must be in accordance with the authorized Fact Sheets.
  • Here is the link to the full FDA updated EUA for Paxlovid – Emergency Use Authorization (EUA).