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Notice of Non-Compliant Security Forms for Prescribing Controlled Substances in California

The California State Board of Pharmacy (Pharmacy Board) has notified the Dental Board of California (DBC) that some dentists may not be using compliant security forms for prescribing controlled substances in California. One of the problems appears to be lack of check off boxes for ordering refills – a required element under the security forms requirements in Health and Safety Code section 11162.1 that has been required for years.

There are a number of non-compliant forms in use by health care professions that were printed by Department of Justice (DOJ) licensed security form printers. The DOJ is working now to get the printers compliant. Meanwhile, the Pharmacy Board is advising Department of Consumer Affairs (DCA) regulatory boards about the problem. The following is the background on this issue:

California Health and Safety Code section 11162.1 contains 14 elements that must appear on California Security Forms, the forms used to prescribe controlled substances in California*. These elements were first enacted in 2003 when the triplicate prescription form was discontinued. The law also requires that California Security Forms must be printed by CA Department of Justice licensed printers. In 2006, the law was amended again to make several changes that took effect in January 2007. Finally, legislation enacted in 2011 required that the California Security Forms in use must be fully compliant with all requirements of the Health and Safety Code by July 1, 2012.

Here is a link to the required elements in the Health and Safety Code (go to page 357).

In recent years, the Pharmacy Board has continued to identify non-compliant California Security Forms in use that have been filled by California pharmacies, in violation of the Health and Safety Code requirements. The Pharmacy Board’s response upon identification of non-compliant forms having been used to dispense controlled drugs is to educate the licensee, and to cite and fine the pharmacy/pharmacists involved. Typically, the licensing board for the prescriber is advised as well.

Recently some pharmacies have begun to refuse to fill prescriptions written on non-compliant forms where item 11162.1(a)(10) is not fully compliant with the required elements. One of these elements is “Check boxes shall be printed on the form so that the prescriber may indicate the number of refills ordered.” There are also additional elements missing on some forms, including lack of a watermark on the reverse of the form.

The Pharmacy Board recently has received complaints from patients or prescribers whose patients have been denied medication from the pharmacy because of the non-compliant forms.

Interim Solutions:

• Prescribers and dispensers need to become familiar with the 14 required elements of the security prescription forms.
• Prescribers with non-compliant forms should reorder compliant forms from a DOJ-licensed security printer.
• Prescribers with non-compliant forms should consider using e-prescribing for controlled substances
.

*Please note this exception to the security forms requirements: controlled substances prescriptions written for patients with a terminal illness may be written on ordinary prescription forms pursuant to section 11159.2 of the Health &Safety Code – here is a link (see page 352).

Questions? Contact the DBC Enforcement Office at 916-274-6326 or by email to dentalboard@dca.ca.gov