A few months ago there was some confusion about some things that the DEA had published about what a Pharmacist may or may not add or change on a C-II prescription.  I got this from the KY BOP, but since all C-II are now sent electronically, the ability to add/alternate data on a C-II may be limited by the pharmacy computer/software system.  This may just the KY BOP restating the obvious law, while stating that the DEA is in the process of changing or creating new regulations and/or interpretations of the CSA…  Which the SCOTUS made a ruling in July 2022 that told EPA & ATF that they could not do make new regulations and/or interpretation of the laws that they are in charge of enforcing. That such actions were limited to Congress to do.

Changes Pharmacists May Make to a Schedule II Paper Prescription

Drug Enforcement Administration (DEA) has issued guidance on what changes a pharmacist
can make on a Schedule II paper prescription. This guidance will remain in effect until DEA
codifies new regulations or until this guidance is otherwise modified or withdrawn by DEA.
According to the guidance, DEA has received an increasing number of questions in the past few
months concerning the 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 is working to draft new regulations. In the interim, pharmacists should adhere to the state
regulations or policy regarding those changes that a pharmacist may make to a Schedule II
prescription after oral consultation with the prescriber. Kentucky has had the following policy
guidance from the Drug Enforcement and Professional Practices Branch of the Office of Inspector
General since 2010:
• After consulting with the prescribing practitioner, a pharmacist may add or modify the
following items:
• date of issue – may be added, but not changed
• drug strength
• quantity – may be modified only in conjunction with a change of strength, and
the total quantity dispensed must not exceed the total dosage authorized
• quantity check-off box marked
• directions for use
• refill instructions (Schedules III-V)
• practitioner’s name – printed (not a signature)
• All consultations must be documented
• The following items may be added or modified without consulting the practitioner if
the information can be obtained from other reliable sources:
• patient’s address

• dosage form
• practitioner’s address – printed
• practitioner’s telephone number
• practitioner’s DEA number
A pharmacist may never change or add the patient’s name, the name of the controlled substance
(except generic substitution permitted by state law), or the signature of the practitioner.
Both state and federal law still require professional judgment by the pharmacist on every
prescription filled. Caution is advised whenever a change or addition is made to any prescription.

Filed under: General Problems