Massachusetts, one of the last states to regulate nonresident pharmacies, will soon require pharmacies that ship drugs into the state to obtain a permit from the Board of Pharmacy. On December 31, 2014, the Massachusetts legislature passed a law requiring the Board to establish a procedure to license nonresident pharmacies. Although the bill passed in 2014, it was not until early August 2015 that the Massachusetts Board of Pharmacy issued draft regulations to implement the bill.
Under the Board’s new draft regulations, a pharmacy located outside of Massachusetts may not dispense or ship any prescription drug into Massachusetts unless it holds a Nonresident Drug Store Pharmacy license. This licensure requirement also extends to nonresident pharmacies dispensing or shipping sterile or non-sterile compounded preparations. If the nonresident pharmacy is shipping or dispensing sterile compounded preparations, it will need both the Nonresident Drug Store Pharmacy License and a Nonresident Sterile Compounding Pharmacy License. Likewise, if the pharmacy is shipping complex non-sterile compounded preparations, it will need a Nonresident Drug Store Pharmacy License and a Nonresident Complex Non-sterile Compounding Pharmacy License.
Under the draft regulations, a nonresident drug store pharmacy must register biennially with the Board. Each permit will expire on December 31 of each odd-numbered year following the date of issuance. To apply for an initial license, a nonresident pharmacy must submit the following items:
- Certificate of good standing from the pharmacy’s home state that was issued within three months;
- An inspection report from a Board approved inspector, conducted within two years;
- A statement of the scheduled hours during which the pharmacy will be open;
- A complete application for a controlled substance registration, if the pharmacy does not already have a Massachusetts controlled substance registration;
- Certified blueprints depicting the pharmacy layout; and
- An attestation of intent to engage in compounding.
Further, nonresident pharmacies will also be required to have a Massachusetts registered pharmacist Manager of Record. The Massachusetts pharmacist must be listed on the application. Although the Board has not yet determined when the new rules will become effective, nonresident pharmacies interested in obtaining a permit should soon begin the process of registering a pharmacist Manager of Record, as it could take weeks or months to complete the process.
The draft regulations also permit the Board to issue provisional licenses in lieu of a Nonresident Drug Store Pharmacy license. These licenses may only be issued if the applicant submits a complete application and demonstrates to the Board that it is in substantial compliance with Massachusetts law and has the potential to achieve full compliance within the provisional license period.
If these regulations are adopted, it will impact every pharmacy outside of Massachusetts that distributes prescription drugs and/or compounded preparations into Massachusetts.