247 CMR, § 6.04 - General Application Requirements
(1) An application
for a Drug Store Pharmacy license, sterile compounding pharmacy license,
complex non-sterile compounding pharmacy license, institutional sterile
compounding pharmacy license, non-resident Drug Store Pharmacy license,
non-resident sterile compounding pharmacy license, and non-resident complex
non-sterile compounding pharmacy license shall be made on forms prescribed by,
and available from, the Board.
(2)
In support of an application for a license to operate a Drug Store Pharmacy,
sterile compounding pharmacy, complex non-sterile compounding pharmacy,
institutional sterile compounding pharmacy, non-resident Drug Store Pharmacy,
non-resident sterile compounding pharmacy, and non-resident complex non-sterile
compounding pharmacy, the applicant shall submit:
(a) complete application forms, signed by:
1. the proposed Massachusetts licensed
pharmacist Manager of Record or, in the case of a non-resident pharmacy, the
designated Massachusetts licensed pharmacist in charge; and
2. each applicant or an individual authorized
to sign on behalf of the applicant(s);
(b) a statement of the scheduled hours during
which the pharmacy is to remain open;
(c) a complete application, available from
the Board, for a Massachusetts controlled substance registration or a copy of
an existing Massachusetts controlled substance registration;
(d) payment of a non-refundable licensing and
application fee as determined by the Executive Office of Administration and
Finance;
(e) blueprints or
equivalent architectural drawings depicting the pharmacy layout;
(f) any request(s) for waiver(s) of Board
regulation(s); and
(g) any
additional information, as required by the Board.
(3) The Board may require the applicant(s),
interest holder(s), the proposed Manager of Record, and any other person as
required by the Board to personally appear before the Board to answer questions
to facilitate the Board's determination whether issuance of a pharmacy license
would not be in the best interest of public health, safety, and
welfare.
(4) The Board may require
an inspection of a pharmacy before granting final approval of an
application.
(5) The Board may
refuse to issue a pharmacy license if the Board finds, in its reasonable
discretion, the applicant(s) and any interest holder(s) are not suitable and
approving the application would not be in the best interest of public health,
welfare, and safety.
(6) All fees
submitted to the Board in connection with an application for a pharmacy license
are nonrefundable.
(7) A pharmacy
shall open within one calendar year of the Board's approval of its application
or obtain written permission from the Board to open more than one calendar year
after the Board's approval of the application.
(8) A pharmacy license shall be
non-transferrable.
(9) Renewal of a
Drug Store Pharmacy, sterile compounding pharmacy, complex non-sterile
compounding pharmacy, institutional sterile compounding pharmacy, non-resident
Drug Store Pharmacy, non-resident sterile compounding pharmacy, and
non-resident complex non-sterile compounding pharmacy licenses and controlled
substance registrations
(a) Application for
renewal of a pharmacy license and controlled substance registration shall be
made by a duly authorized representative of the pharmacy in the form and manner
determined by the Board. A renewal application form shall be fully and properly
completed and submitted to the Board in a timely manner.
(b) A licensee shall submit payment of a
non-refundable licensing and application fee as determined by the Executive
Office of Administration and Finance.
(c) Each renewal application shall be
accompanied by an attestation that the pharmacy complied with all mandatory
reporting during that licensing period in accordance with 247 CMR 20.00:
Reporting.
(d) The
Board may renew a pharmacy license and controlled substance registration if the
Board finds, in its reasonable discretion, the licensee(s) and any interest
holder(s) are suitable and approving the application would be consistent with
the best interest of public health, welfare, and
safety.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
(1) An application for a Drug Store Pharmacy license, sterile compounding pharmacy license, complex non-sterile compounding pharmacy license, institutional sterile compounding pharmacy license, non-resident Drug Store Pharmacy license, non-resident sterile compounding pharmacy license, and non-resident complex non-sterile compounding pharmacy license shall be made on forms prescribed by, and available from, the Board.
(2) In support of an application for a license to operate a Drug Store Pharmacy, sterile compounding pharmacy, complex non-sterile compounding pharmacy, institutional sterile compounding pharmacy, non-resident Drug Store Pharmacy, non-resident sterile compounding pharmacy, and non-resident complex non-sterile compounding pharmacy, the applicant shall submit:
(a) complete application forms, signed by:
1. the proposed Massachusetts licensed pharmacist Manager of Record or, in the case of a non-resident pharmacy, the designated Massachusetts licensed pharmacist in charge; and
2. each applicant or an individual authorized to sign on behalf of the applicant(s);
(b) a statement of the scheduled hours during which the pharmacy is to remain open;
(c) a complete application, available from the Board, for a Massachusetts controlled substance registration or a copy of an existing Massachusetts controlled substance registration;
(d) payment of a non-refundable licensing and application fee as determined by the Executive Office of Administration and Finance;
(e) blueprints or equivalent architectural drawings depicting the pharmacy layout;
(f) any request(s) for waiver(s) of Board regulation(s); and
(g) any additional information, as required by the Board.
(3) The Board may require the applicant(s), interest holder(s), the proposed Manager of Record, and any other person as required by the Board to personally appear before the Board to answer questions to facilitate the Board's determination whether issuance of a pharmacy license would not be in the best interest of public health, safety, and welfare.
(4) The Board may require an inspection of a pharmacy before granting final approval of an application.
(5) The Board may refuse to issue a pharmacy license if the Board finds, in its reasonable discretion, the applicant(s) and any interest holder(s) are not suitable and approving the application would not be in the best interest of public health, welfare, and safety.
(6) All fees submitted to the Board in connection with an application for a pharmacy license are nonrefundable.
(7) A pharmacy shall open within one calendar year of the Board's approval of its application or obtain written permission from the Board to open more than one calendar year after the Board's approval of the application.
(8) A pharmacy license shall be non-transferrable.
(9) Renewal of a Drug Store Pharmacy, sterile compounding pharmacy, complex non-sterile compounding pharmacy, institutional sterile compounding pharmacy, non-resident Drug Store Pharmacy, non-resident sterile compounding pharmacy, and non-resident complex non-sterile compounding pharmacy licenses and controlled substance registrations
(a) Application for renewal of a pharmacy license and controlled substance registration shall be made by a duly authorized representative of the pharmacy in the form and manner determined by the Board. A renewal application form shall be fully and properly completed and submitted to the Board in a timely manner.
(b) A licensee shall submit payment of a non-refundable licensing and application fee as determined by the Executive Office of Administration and Finance.
(c) Each renewal application shall be accompanied by an attestation that the pharmacy complied with all mandatory reporting during that licensing period in accordance with 247 CMR 20.00: Reporting.
(d) The Board may renew a pharmacy license and controlled substance registration if the Board finds, in its reasonable discretion, the licensee(s) and any interest holder(s) are suitable and approving the application would be consistent with the best interest of public health, welfare, and safety.