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Frequently Asked Questions for Pharmacists on Combination Products Containing a Schedule II Drug and Acetaminophen

Q: Can a pharmacist change or add the correct amount of acetaminophen to a prescription for a combination product containing a schedule II drug and acetaminophen?

A: Yes.  If a pharmacist receives a prescription for a combination product containing a schedule II drug and acetaminophen that appears to have a missing, incorrect, or unavailable acetaminophen dosage, the pharmacist may add or change the amount of acetaminophen written on the prescription after speaking directly with the prescriber and documenting the clarification on the prescription.


(a)  A prescriber writes for “Vicodin 5/325.”   As pharmacists know, Vicodin is now formulated as hydrocodone 5mg /acetaminophen 300 mg.  The pharmacist may call the prescriber to clarify which product was intended – e.g., Vicodin 5/300 or another hydrocodone 5 mg/acetaminophen product containing 325 mg of acetaminophen per dosage unit (see (b) below).   The pharmacist must document on the prescription the changes made after consultation with the prescriber.

(b) A prescriber writes for “Vicodin 5/325,” but the prescriber intended to write for Norco (hydrocodone 5 mg /acetaminophen 325 mg).  The pharmacist may change the brand name to match the correct combination product intended.  The pharmacist must document the clarification after consultation with the prescriber.


Q.  Doesn’t the Drug Enforcement Administration (DEA) prohibit the kind of clarifications described above?

A.  No.  DEA advises that “pharmacists are instructed 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. . . .[W]hen  information is missing from or needs to be changed on a schedule II controlled substance prescription, DEA expects pharmacists to use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription.”



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