California Rule Change: Drug Labeling Requirements

February 15, 2017
Firm Publication

Recently, the California Board of Pharmacy announced changes to its drug labeling rules that will take effect on April 1, 2017. The Board of Pharmacy amended Section 1744 of Article 5 of Division 17 of Title 16 of the California Code of Regulations to require that a pharmacist notify patients, via a written label on the drug container, of the risk associated with any drug that (1) may impair a user’s ability to operate a vehicle or vessel, or (2) poses a substantial risk to the person consuming the drug when taken in combination with alcohol.

In addition to identifying certain classes of drug products for which such a label must be included, the amended rule also requires that the pharmacist use his or her professional judgment to determine whether such a label must be included with any other prescription. The previous rule required that the patient be informed of relevant risks, but did not require that written notice of such risks be provided on the label. This updated provision supplements California’s existing rules addressing “patient-centered labels” for prescription drugs.

Pharmacies serving California patients should review their processes to ensure this written notice is included with any such drugs dispensed to a California patient. Should you have any questions, please contact one of the authors listed or any member of our Specialty Pharmacy & Pharmaceuticals team.