Starting January 1, 2019, a new security feature must appear on California prescription forms for controlled substances. The legislature amended Health & Safety Code § 11162.1 by adding the 15th security feature: a uniquely serialized number attributable to a prescriber.

Most prescribers still use their old prescription forms, which do not have a serialized number. If a CII is dispensed based on a non-compliant prescription, such dispensing may be deemed invalid and in violation of state law.

Two years ago, when California State Board of Pharmacy rolled out a requirement that secure blanks must have the statement “Prescription is void if the number of drugs prescribed is not noted” many prescribers continued using their non-compliant blanks. This caused many pharmacies substantial fines and citations from the Board of Pharmacy. To avoid any citation or fines from the Board or the DEA this year, assure that the forms are compliant with the new requirement prior to dispensing.

The Board’s Enforcement Committee recommended that the Board does not take any actions against pharmacies dispensing on old blanks prior to July 1, 2019. Nevertheless, train your pharmacy staff to spot prescriptions that do not comply with Health & Safety Code § 11162.1. It requires:

  1. A latent, repetitive “void” pattern

  2. A watermark “California Security Prescription” on the back

  3. A chemical void protection paper

  4. A feature printed in thermochromic ink.

  5. An area of opaque writing

  6. A description of the security features

  7. Six quantity check off boxes

  8. A Statement printed on the bottom of the prescription blank that the “Prescription is void if the number of drugs prescribed is not noted”

  9. The preprinted name, category of licensure, license number, federal controlled substance registration number, and address of the prescribing practitioner

  10. Check boxes for the number of refills

  11.  The date of origin of the prescription

  12.  A check box indicating the prescriber’s order not to substitute

  13. An identifying number assigned to the approved security printer

  14. A check box by the name of each prescriber when a prescription form lists multiple prescribers

  15. A uniquely serialized number attributable to a prescriber.

A controlled substance security prescription form that does not bear all 15 security features will be presumptively invalid.

Remember that prescriptions for terminally ill patients and emergency prescriptions do not have to comply with the above requirements as long as they comply with their own rules (Sec. 11159.2 for terminally ill patients and Sec. 11167 for emergency prescriptions).

Here is a link to a California Medical Board announcement regarding new prescription forms, which you can forward to practitioners and advise them to change the forms.