Posted: 02 Apr 2020 02:15 AM PDT
By Kalie E. Richardson —
We previously blogged on a number of pharmacy law waivers issued by state pharmacy regulators in response to COVID-19. Waivers are being updated and added to state pharmacy websites daily to address the constantly changing public health and regulatory landscape. This blog post addresses a few recent waivers related to the controlled substances distribution and inventory requirements and a waiver related to non-resident facility licensing similar to those covered in the last post.
Controlled Substances: Distribution
Michigan
On March 30, Michigan Governor Gretchen Whitmer issued Executive Order 2020-30 (COVID-19), which provides temporary relief from certain restrictions and requirements pertaining to the provision of medical services in connection with COVID-19 response. The Executive Order authorizes any drug manufacturer or wholesale distributer licensed in good standing in another state to temporarily distribute controlled substances in Michigan to a hospital, manufacturer, or wholesale distributor. However, to be considered licensed in good standing, the manufacturer/wholesale distributor must not have any pending disciplinary action or a suspended or revoked license in any other state. The “licensed in good standing” requirement is not limited to the facility’s home state license. The Executive Order will remain in effect until the end of the declared emergency.
Ohio
On March 31, the State of Ohio Board of Pharmacy also issued a guidance on the temporary off-site storage of dangerous drugs by a terminal distributor of dangerous drugs (TDDD). Ohio regulations define “dangerous drug” as any drug or drug product whose commercial package bears a label containing the symbol “Rx only”, the legend “Caution: Federal Law Prohibits Dispensing Without Prescription” or “Caution: Federal Law Restricts This Drug To Use By Or On The Order Of A Licensed Veterinarian,” or any similar restrictive statement and, thus, includes both drugs that are controlled substances and non-controlled substances. OAC Ann. 4729-9-01(A).
Under the new guidance, Ohio facilities licensed as a TDDD may maintain possession, custody, or control of dangerous drugs for the treatment of COVID-19 patients at a satellite location other than or in addition to its actual licensed location, subject to certain requirements. The TDDD using an off-site satellite location is responsible for implementing policies and procedures to ensure that drugs stored at the off-site location are kept under supervision and control of licensed healthcare personnel. For non-controlled substances, this may be a “licensed, registered, or certified healthcare provider.” However, supervision of controlled substances is limited to prescribers, pharmacists, physician assistants, and nurses (including APRN, RN, LPN). If supervision is not provided, the drugs must be physically secured in a manner to prevent unauthorized access. TDDDs must also take reasonable efforts to ensure the drugs are properly stored, and must maintain all required records (e.g., receipt, dispensation, disposal).
Off-site storage does not need to be approved by the Board, but the TDDD must submit a COVID-19 Satellite Registration Form prior to engaging in off-site storage.
Controlled Substances: Inventory
Ohio
On March 31, the State of Ohio Board of Pharmacy announced a temporary extension of the annual controlled substance inventory requirement. The Board extends the inventory date to August 1, 2020 for any annual controlled substance inventory that is required between March 2, 2020 and June 30, 2020. However, the inventory must incorporate the additional months included as part of the extension period.
California
The California State Board of Pharmacy had previously issued a similar waiver related to controlled substance inventories. California is allowing pharmacies to complete inventory reconciliation reports at least once every six months, rather than every three months, if determined to be necessary by the pharmacist-in-charge to ensure continuity of direct patient care activities that would otherwise be impacted.
Massachusetts
Massachusetts requires that pharmacies maintain a perpetual inventory of schedule II controlled substances that must be reconciled at least once every ten days. 247 CMR 9.01(14). However, as of April 1, the Massachusetts Board of Pharmacy has stated that it “does not intend to take any enforcement action against pharmacies that perform and reconcile perpetual inventory counts as least every 30 days” for the duration of the declared emergency.
Facility Licensing
South Carolina
The South Carolina Board of Pharmacy issued an Order Regarding Temporary Non-Resident Permits that directs Board staff to issue 90-day temporary permits to non-resident facilities that are permitted in good standing in with states. The order applies to out-of-state pharmacies, manufacturers, wholesale distributors, 3PLs, and FDCA Section 503B outsourcing facilities. Typically, applicants must personally appear before the Non-Resident Application Review Committee, but this Order allows for a remote interview of the applicant by Board staff. Temporary permits are to be issued within 24 hours of receipt of a completed application.
***
We intend to regularly update our blog readers with other Board of Pharmacy COVID-19 related changes, so please check back often.
We previously blogged on a number of pharmacy law waivers issued by state pharmacy regulators in response to COVID-19. Waivers are being updated and added to state pharmacy websites daily to address the constantly changing public health and regulatory landscape. This blog post addresses a few recent waivers related to the controlled substances distribution and inventory requirements and a waiver related to non-resident facility licensing similar to those covered in the last post.
Controlled Substances: Distribution
Michigan
On March 30, Michigan Governor Gretchen Whitmer issued Executive Order 2020-30 (COVID-19), which provides temporary relief from certain restrictions and requirements pertaining to the provision of medical services in connection with COVID-19 response. The Executive Order authorizes any drug manufacturer or wholesale distributer licensed in good standing in another state to temporarily distribute controlled substances in Michigan to a hospital, manufacturer, or wholesale distributor. However, to be considered licensed in good standing, the manufacturer/wholesale distributor must not have any pending disciplinary action or a suspended or revoked license in any other state. The “licensed in good standing” requirement is not limited to the facility’s home state license. The Executive Order will remain in effect until the end of the declared emergency.
Ohio
On March 31, the State of Ohio Board of Pharmacy also issued a guidance on the temporary off-site storage of dangerous drugs by a terminal distributor of dangerous drugs (TDDD). Ohio regulations define “dangerous drug” as any drug or drug product whose commercial package bears a label containing the symbol “Rx only”, the legend “Caution: Federal Law Prohibits Dispensing Without Prescription” or “Caution: Federal Law Restricts This Drug To Use By Or On The Order Of A Licensed Veterinarian,” or any similar restrictive statement and, thus, includes both drugs that are controlled substances and non-controlled substances. OAC Ann. 4729-9-01(A).
Under the new guidance, Ohio facilities licensed as a TDDD may maintain possession, custody, or control of dangerous drugs for the treatment of COVID-19 patients at a satellite location other than or in addition to its actual licensed location, subject to certain requirements. The TDDD using an off-site satellite location is responsible for implementing policies and procedures to ensure that drugs stored at the off-site location are kept under supervision and control of licensed healthcare personnel. For non-controlled substances, this may be a “licensed, registered, or certified healthcare provider.” However, supervision of controlled substances is limited to prescribers, pharmacists, physician assistants, and nurses (including APRN, RN, LPN). If supervision is not provided, the drugs must be physically secured in a manner to prevent unauthorized access. TDDDs must also take reasonable efforts to ensure the drugs are properly stored, and must maintain all required records (e.g., receipt, dispensation, disposal).
Off-site storage does not need to be approved by the Board, but the TDDD must submit a COVID-19 Satellite Registration Form prior to engaging in off-site storage.
Controlled Substances: Inventory
Ohio
On March 31, the State of Ohio Board of Pharmacy announced a temporary extension of the annual controlled substance inventory requirement. The Board extends the inventory date to August 1, 2020 for any annual controlled substance inventory that is required between March 2, 2020 and June 30, 2020. However, the inventory must incorporate the additional months included as part of the extension period.
California
The California State Board of Pharmacy had previously issued a similar waiver related to controlled substance inventories. California is allowing pharmacies to complete inventory reconciliation reports at least once every six months, rather than every three months, if determined to be necessary by the pharmacist-in-charge to ensure continuity of direct patient care activities that would otherwise be impacted.
Massachusetts
Massachusetts requires that pharmacies maintain a perpetual inventory of schedule II controlled substances that must be reconciled at least once every ten days. 247 CMR 9.01(14). However, as of April 1, the Massachusetts Board of Pharmacy has stated that it “does not intend to take any enforcement action against pharmacies that perform and reconcile perpetual inventory counts as least every 30 days” for the duration of the declared emergency.
Facility Licensing
South Carolina
The South Carolina Board of Pharmacy issued an Order Regarding Temporary Non-Resident Permits that directs Board staff to issue 90-day temporary permits to non-resident facilities that are permitted in good standing in with states. The order applies to out-of-state pharmacies, manufacturers, wholesale distributors, 3PLs, and FDCA Section 503B outsourcing facilities. Typically, applicants must personally appear before the Non-Resident Application Review Committee, but this Order allows for a remote interview of the applicant by Board staff. Temporary permits are to be issued within 24 hours of receipt of a completed application.
***
We intend to regularly update our blog readers with other Board of Pharmacy COVID-19 related changes, so please check back often.
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