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Compliance

Pharmacy compliance is twofold. First, submission of controlled substance data must occur within twenty-four (24) hours of dispensation. Second, submissions must occur every twenty-four (24) hours (or next business day).  If your facility dispenses less than one (1) controlled substance prescription on a given day, you must submit a zero report.

Failure to submit controlled substance data, or a zero report in lieu of data, in a complete and timely manner may result in the issuance of disciplinary action by the Indiana Board of Pharmacy and/or a personal appearance before the Board. Errant records do not make it into the INSPECT database. Failure to correct errant records constitutes non-compliance.

IC 35-48-7-8 (1) states, “Each time ephedrine, pseudoephedrine, or a controlled substance designated by the board under IC 35-48-2-5 through IC 35-48-2-10 is dispensed, the dispenser shall transmit to the INSPECT program…”

When a pharmacy is found to be non-compliant, INSPECT sends an initial warning notification. Upon the second instance of non-compliance, INSPECT sends a warning via certified mail restating the dates of submission and warning that the next issue of non-compliance will result in a board appearance. When the pharmacy incurs the third instance of non-compliance, a board appearance notification will be sent to the Pharmacist-in-Charge of the location.

ZERO REPORTING & exemptions

To report zero dispensations for a facility for a given period of time, an account must be created in the INSPECT PMP Clearinghouse.

You may report "Exempt" for a facility if that facility does not stock and does not dispense controlled substances to Indiana residents. If the facility stocks controlled substances but does not dispense to IN residents, a zero report must be completed every twenty-four (24) hours on behalf of that facility.

To request an exemption please email Bill Woodruff at wwoodruff1@pla.in.gov .