The California Board of Pharmacy’s July 2018 issue of “The Script” highlights new regulations on inventory reconciliation of controlled substances. Because dispensing controlled substances is still the most frequently cited disciplinary offense, this post focuses and further explains some of the requirements. The regulation could be found in California Code of Regulations, title 16, Section 1715.65. It became effective in April 2018, so by now you should have performed your first inventory of Schedule IIs. If you haven’t – do so as soon as possible assuring full compliance with the regulations.

In a nutshell, the regulations require all pharmacies licensed in California – and certain clinics – to perform periodic inventory for all controlled substances. Schedule II inventory should be performed quarterly and should involve manual count and a comparison with the last inventory. If any discrepancies are found, they must be reported to the Board (note: the DEA requires only substantial losses to be reported). A discrepancy should be reported to the Board within 30 days of the discovery (or 14 days if theft, self-use or diversion is the cause). The discrepancy must be reported, even if the pharmacy is still not clear about the cause (same applies to the DEA reporting). A good approach is to report and state that the investigation is on-going, and then amend or withdraw the report later, if needed.

All new PICs must perform an inventory reconciliation report within 30 days of becoming the PIC.

For Inpatient Hospital Pharmacy: all the above applies plus perform the same in all satellite locations.

For Automated Drug Delivery Systems: all above requirements apply. The inventory reconciliation should be performed at all locations. During an inventory reconciliation, the PIC must verify that access was limited only to facility personnel.

Important practice pointers:

Follow Federal Schedules: states’ schedules of controlled substances are different from federal’s. Pharmacies should follow federal schedules (it becomes especially pertinent when reconciling Schedule IIs). Pharmacy may add additional drugs to its reconciliation report (i.e. costly drugs).

No estimation: for Schedule IIs the inventory reconciliation should include a physical count, not an estimate (already required by the federal law). For other schedules, you can estimate the number, unless the container holds more than 1,000 tablets or capsules in which case a pharmacy must make an exact count of the contents.

      Per Board of Pharmacy’s guidance:

  • “where there is a unit of use container, a pharmacist should accept the measurement printed on the container and include it in the physical count. However, if he unit of use container looks damaged or altered in some manner, treat the item as quarantined.

  • Where multi-dose containers are used, a pharmacist should subtract the amount dispensed from the measurement printed on the container. Subsequently, the pharmacist should document the remaining amount on the container itself.

Example: A pharmacist dispensed 240ml from a 473ml stock bottle. The pharmacist would subtract 240ml from 473ml and document the difference of 233ml on the stock bottle. The remaining amount of 233ml would be used as the physical count for the reconciliation report.”

Reports for Schedule III-V: under the federal law a provider should inventory Schedules III-V every two years. The Board recommends to do so more often, however, no clear guidance is given, simply “to follow the standard of practice in the community.” At least once a year is probably a good estimate in most communities in California.

Perpetual inventory: keeping a perpetual inventory does not satisfy the above regulations because it requires a physical count of Schedule IIs and a reconciliation with all acquisitions and dispositions (every 3 months).

Electronic records: all reports may be compiled and maintained digitally.

Who must perform the reconciliation: at least two persons should be performing the reconciliation, such as the PIC and an assistant (pharmacists or licensed pharmacy technicians).  Note: unlicensed individuals (such as clerks) should not prepare or complete the report.