On June 11, 2014, Pennsylvania’s House of Representatives passed House Bill 1822, which — if signed into law — would require nonresident pharmacies to register with the Pennsylvania Board of Pharmacy (“the Board”). The bill for the first time vests the Board with regulatory oversight over nonresident pharmacies, which are pharmacies that are outside of Pennsylvania but ship, mail, or deliver prescription medications into Pennsylvania. Because Pennsylvania is one of a decreasing handful of states that does not regulate nonresident pharmacy practice, this bill forewarns of signifcant changes to pharmacy businesses nationwide. The bill is currently before the Pennsylvania Senate’s committee on Consumer Protection & Professional Licensure, so some changes to the bill may occur before it is passed into law.
Under House Bill 1822, a nonresident pharmacy must register biennially with the Board. The Board will then issue a certificate of registration to allow a nonresident pharmacy to deliver prescription medications into Pennsylvania. To register initially or to renew registration, a nonresident pharmacy must:
- Disclose names and titles of all principal corporate officers and the pharmacist in charge.
- Disclose any change of location or the pharmacist in charge within 30 days.
- Submit a statement that the pharmacy complies with all directions and requests for information from the regulatory or licensing agent of the state in which it is licensed.
- Maintain a valid, unexpired license, permit, or registration to make the pharmacy in compliance with the laws of the state in which the pharmacy is located.
- Submit a copy of the most recent inspection report from an inspection by the regulatory or licensing agency of the state in which the nonresident pharmacy is located or by the National Association of Boards of Pharmacy’s Verified Pharmacy Program.
A nonresident pharmacy may not ship, mail, or deliver prescription medication until the pharmacy has been issued a certificate of registration by the Board and has paid the fee for registration. Additionally, until a nonresident pharmacy has been issued a certificate of registration, it may not advertise its services in Pennsylvania with the knowledge that the advertisement is likely to induce citizens of Pennsylvania to use the pharmacy to dispense prescriptions.
Notably, as currently drafted, the bill would impose only minimal regulatory burden on nonresident pharmacy practice. Stakeholders should pay careful attention to committee meetings and other drafts of the bill as it is amended through the legislative process. It is possible that more onerous regulatory requirements, such as compliance with specific Pennsylvania laws and/or a requirement that the pharmacist-in-charge hold a Pennsylvania license could be added.
Notwithstanding the minimal requirements imposed by the current draft, the bill also establishes reasons the Board can deny, revoke, or suspend nonresident pharmacies’ certificates of registration. Specifically, a certificate of registration may be denied, revoked, or suspended if the nonresident pharmacy fails to comply with the requirements of House Bill 1822, causes serious bodily or psychological injury to a resident of Pennsylvania, or has had its permit to conduct a pharmacy suspended, revoked, or disciplined by the licensing authority of another state.
Additional Requirements Applicable to Nonresident Pharmacies
The bill imposes additional operational compliance obligations on registered nonresident pharmacies. These obligations include:
- Providing a toll-free telephone number, which is in operation during the pharmacy’s regular hours, at least 40 hours and six days per week, to facilitate communication between patients in Pennsylvania and a licensed pharmacist. The telephone number must be disclosed on each container of drugs dispensed to patients in Pennsylvania.
- Reporting, within 30 days, any final disposition of disciplinary action taken by the regulatory or licensing agency of the state in which the nonresident pharmacy is located.