State of Maine licensed pharmacies may apply for a waiver from electronic submission of controlled substance prescription information under the following circumstances.
- The volume of controlled substances dispensed is so low, financial hardship will result from being required to make electronic submissions of prescription monitoring information.
- The pharmacy does not currently deliver and/or dispense any controlled substances to ultimate users who have a Maine address.
- If pharmacies identify other good cause, they may request a waiver by further explaining the circumstances and attaching substantiating documentation.
Process for Submitting a Waiver
- Waivers must be requested from the Office of Substance Abuse and Mental Health Services (SAMHS), Prescription Monitoring Program (PMP) (the “Office”) in writing.
- Responses to waiver requests will be made on no later than sixty (60) days from the date a completed application is received by the office.
Waivers may be granted wholly or partially depending on the circumstances.
- If the pharmacy fills ten (10) or less prescriptions per month, then the pharmacy may be granted a waiver to submit reporting on a monthly basis rather than on a weekly basis as stated in the DHHS Rule. Submissions must be done each month no later than by the 7th of each month.
- If the Pharmacy does not dispense and/or deliver any controlled substances, then the pharmacy may be approved to upload data on a quarterly basis. Submissions must be done each calendar quarter no later than by the 7th of each quarter (Jan. 7th, April 7th, July 7th & Dec. 7th).
- Waiver may be approved if the pharmacy identifies any other good cause. Duration of the waiver will depend on circumstance of the pharmacy’s status.
- Regardless of whether transactions for Schedule II, III or IV drugs occurred during a reporting period the pharmacy must submit “no activity” report unless a waiver has been approved by SAMHS.
- Pharmacies must resubmit the Request for Waiver every year at the time of the Maine license renewal (every December 31st) to re-certify that the pharmacy does not deliver and/or dispense any controlled substances covered by the PMP.
- Complaint will be filed with the Maine Board of Pharmacy for pharmacies not in compliance with the PMP reporting requirements.
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