Multiple C-II Ruling…Pharmacist’s Ability to Change a C-II???

I would like to apologize to everyone for starting a “state-wide panic” and I would especially like to apologize to the Board of Pharmacy and Compliance Officer for making their lives so difficult these last few days. I would like to reassure everyone that the Board of Pharmacy and Compliance Officer are checking into the matter of a pharmacist’s ability to change a scheduled II prescription with a verbal confirmation and documentation with the DEA in which to have something official IN WRITING to report to you. Unfortunately, my contact at the DEA, whom is a Programs Analyst, Liaison and Policy Section, OD for the DEA in Washington, DC reported to our Compliance Officer that she is not authorized to answer his questions, even though she freely spoke to me about the new policy stating that a “pharmacist can not change anything on a C-II,” which is published on MT RPh NEWS.

Everything I published to you was factual and checked multiple times with multiple questions; however, it was single sourced and needs further investigation. Unfortunately, the Chief, Liaison and Policy Section, at the DEA I really wanted to speak with has not returned any of my 3 phone calls since I started calling him on December 26th. The Program Analyst that is in Marks division was nice enough to promptly return my phone calls on December 28th and January 10th and answered my questions with confidence; however, she won’t produce anything in writing. I encourage everyone to relax about the issue and to use their best judgment until the Montana Board of Pharmacy reaches a decision to publish. As soon as I am able to get something IN WRITING from someone a little higher up at the DEA to post on the site with the assistance of the Board of Pharmacy, or a statement from the Board of Pharmacy, I will do so…of course this may take a while, so I urge you to use the same sound judgment and rules that we have currently been using until that time comes.

So at this point in time, just realize that the Federal Register, which was finalized on December 19th, does state:

“In addition, because the CSA states that prescriptions for schedule II controlledsubstances must be written (21 U.S.C. 829(a)), the essential elements of theprescription written by the practitioner (such as the name of the controlledsubstance, strength, dosage form, and quantity prescribed, and-in the case ofmultiple prescriptions under this Final Rule-the earliest date on which theprescription may be filled) may not be modified orally.”

And that the matter is being looked into by Montana’s finest. The Pharmacist Letter is also covering this issue regarding the “discrepancy” so they may have an answer in their February Article. I encourage you to use your best judgment until matters are even further clarified officially IN WRITING. In addition, I would also encourage anyone who has questions about this issue to contact the Board of Pharmacy or Compliance Officer if needing further advice on dispensing under this new ruling, especially if you are thinking of turning a customer away do to an error on the prescription that you are able to clarify and document. Thank you!

Eric Shields, Pharm.D.