State Regulators Issue Pharmacy Law Waivers in COVID-19 ResponseMarch 30, 2020
As part of a larger COVID-19 outbreak response effort, many state pharmacy regulators have issued waivers or temporary suspensions of certain pharmacy laws. The California State Board of Pharmacy, State of Ohio Board of Pharmacy, Pennsylvania Department of State, and Texas State Board of Pharmacy have all issued COVID-19-related waivers or suspensions affecting both pharmacy staffing and licensing. These waivers meet the dual objectives of enhancing pharmacy response to the ongoing COVID-19 pandemic, while also allowing pharmacy staff to responsibly practice social distancing. This is merely a sample of an ever changing landscape and we will provide updated information regarding these waivers when possible.
As of March 20, California will allow the ratio of pharmacists to intern pharmacists to increase to allow for one additional pharmacy intern, so long as certain conditions are met. California currently allows for a pharmacist to supervise no more than two intern pharmacists at any one time. Cal. Bus. & Prof. Code § 4114(b). The pharmacy must document the need for the modification due to the COVID-19 public health emergency. The intern pharmacist must have an anticipated graduation date in 2020, or have graduated from a recognized school of pharmacy, or be certified by the Foreign Pharmacy Graduate Equivalency Committee. Similarly, California is also permitting an adjustment of the ratio of pharmacy technicians to pharmacists to allow for one additional technician for each supervising pharmacist. California law currently allows for a pharmacist to technician ratio of 2:1, with some limited exceptions. Cal. Bus. & Prof. Code § 4115(f). A waiver granted by the Board is limited to 30 days. All documentation and justification related to the staffing ratio waivers must be maintained for one year following the end of the declared emergency.
As of March 18, California is expanding the activities permissible as “remote processing.” Pharmacists performing remote processing may also receive, interpret, evaluate, clarify, and approve medication orders and prescriptions, including medication orders and prescriptions for controlled substances classified as Schedule II, III, IV or V. The pharmacist remote processing waiver does not extend to final product verification and dispensing. The waiver also allows pharmacists to supervise processing done by interns and technicians remotely using technology. Pharmacists who are supervising remotely must be readily available to answer questions and must verify the work performed by the intern or technician.
As of March 21, California will allow a licensed pharmacy to receive prescription drugs and devices from an unlicensed pharmacy, wholesaler, or third-party logistics provider located in another state to alleviate a temporary shortage that could lead to a denial of healthcare, under certain conditions. The unlicensed entity must be appropriately licensed in its home state and the California pharmacy must maintain documentation of the license verification. The California pharmacy must also maintain documentation of the temporary shortage of the drug or device received from the unlicensed entity and the drug or device must have been produced by an FDA-registered manufacturer. Under the Board’s policy, a waiver granted by the Board is limited to 30 days. All documentation related to the waiver must be maintained and readily retrievable for three years following the end of the declared emergency.
As of March 13, Ohio has authorized remote order entry for all licensed/registered pharmacist, pharmacy interns, and pharmacy technicians. Remote processing includes data entry functions, but does not include dispensing. For pharmacists, remote processing includes activities such as receiving and interpreting medication orders and performing prospective drug utilization review. For technicians and interns, remote processing includes activities such as order entry and insurance processing. This guidance is in effect until rescinded by the Board.
In an effort to ensure drug supply chain continuity, Ohio is expediting licensure for “drug distributors” which under Ohio regulations includes wholesale distributors (including brokers and wholesalers), manufacturers, outsourcing facilities, third-party logistics providers, and repackagers. In order to expedite licensure, the Board is temporarily waiving the requirement for the submission of ownership/officer and responsible person criminal records checks prior to the initial issuance of a drug distributor license received on or after March 2, 2020. Instead, the drug distributor will have 120 days from the date the application is submitted to submit fingerprints for criminal records checks to the Ohio Bureau of Criminal Investigation. The expedited licensure guidance shall remain in effect until June 14, 2020 or when Ohio’s emergency orders are lifted, whichever is earlier.
As of March 24, Ohio is also allowing the sale and shipment of certain prescription drugs that are in shortage by out-of-state facilities that are not licensed in Ohio. This guidance applies to drugs on the FDA’s drug shortage list and drugs on the American Society of Health-System Pharmacists drug shortage list. Controlled substances and prescription drugs containing gabapentin are excluded from the policy. In order for an Ohio terminal distributor of dangerous drugs (TDDD) to receive drugs to alleviate a shortage, the unlicensed location must be properly licensed in good standing in its home state and the Ohio TDDD must maintain the licensure verification. The TDDD must also main documentation of the shortage for any drug received under this guidance and the drug must be produced by an FDA-registered drug manufacturer. The TDDD must comply with all recordkeeping requirements and all documentation and records must be maintained and readily retrievable for three years following the end of the declared public health emergency. The unlicensed facility must submit an Out-of-State Shipment Notification Form to the Board of Pharmacy prior to shipping any drugs to the Ohio TDDD. This guidance shall remain in effect until June 14, 2020 or when Ohio’s emergency orders are lifted, whichever is earlier.
As of March 22, Pennsylvania is allowing pharmacists to supervise pharmacy interns and technicians responsible for data entry via “technological means.” The pharmacy must have documented policies and procedures to protect against patient harm and the pharmacist must be readily available to answer questions and be fully responsible for the practice and accuracy of the intern or technician. This suspension does not allow for pharmacy technicians and interns to fill prescriptions from a remote location; a pharmacist is still required to be on-site to fill prescriptions.
As of March 22, Pennsylvania is temporarily suspending the requirement for a non-resident pharmacy registration for the duration of the COVID-19 emergency. An out-of-state pharmacy that does not hold a Pennsylvania non-resident pharmacy registration may ship into the state so long as the pharmacy has access to common patient files, has a business relationship with a Pennsylvania pharmacy and is licensed in good standing in the home state. The requirement for nonresident pharmacy registration is temporarily suspended for the duration of the COVID-19 emergency.
On March 20th, Texas temporarily suspended the requirement of in-person contact for patient consultation and will allow for telephonic consultation. The suspension of the in-person consultation requirement remains in effect until terminated by the Office of the Governor or until the March 13, 2020 disaster declaration is lifted or expires.
Texas has also temporarily suspended the inspection requirement to renew Class A-S (community pharmacy engaged in sterile compounding), Class B (nuclear pharmacies), Class C-S (hospital, ambulatory surgery center, or institutional pharmacy engaged sterile compounding), and Class E-S (non-resident pharmacy engaged in sterile compounding) pharmacies. This will allow pharmacies with these license types that have not been inspected by the Board within the last renewal period to still renew their pharmacy licenses. The waiver does not apply to other classes of pharmacy licenses (e.g., Class D clinic pharmacies, Class F freestanding emergency medical care center pharmacies). The suspension of the inspection requirement remains in effect until terminated by the Office of the Governor or until the March 13, 2020 disaster declaration is lifted or expires.