Chapter 30. Change to Permit — Pharmacy or Wholesale Distribution Permit Holder
Regulation .01 Application for Name Change.LinkCopy Citation
The name of an individual or entity required to possess a pharmacy or wholesale distribution permit may be changed on a permit if:
A.
The permit holder submits a notice of name change to the Board within 30 days after the name change, on a form that the Board requires;
B.
The permit holder submits to the Board documentation verifying the name change; and
C.
There is no other change in the individual or entity required to possess a pharmacy or wholesale distribution permit including no change in controlling ownership interest, type of business entity, or location.
Regulation .02 Application for Name Change — Fee.LinkCopy Citation
There is no fee for a name change under this chapter.
Regulation .03 Applications for Pharmacy or Wholesale Distributor Establishment Change of Ownership.LinkCopy Citation
If the controlling interest in ownership of a pharmacy or wholesale distributor changes, the new owner shall:
A.
Submit an initial application and fee for a pharmacy or wholesale distributor permit, as applicable; and
B.
Submit and comply with the requirements of closing and opening operations as set forth in:
(1)
COMAR 10.34.14, for pharmacies; and
(2)
Health Occupations Article, §12-6C-05(d), Annotated Code of Maryland, and COMAR 10.34.22.10, for wholesale distributors.
Regulation .04 Applications for Pharmacy or Wholesale Distributor Establishment Change of Location.LinkCopy Citation
A.
Permits issued to operate a pharmacy or engage in wholesale distribution, whether located in the State or outside the State, are:
(1)
Not transferable; and
(2)
Specific to the establishment location that has undergone an opening inspection by the Board.
B.
A pharmacy or wholesale distributor that intends to change its establishment location shall:
(1)
Submit an application to the Board on a form required by the Board;
(2)
If located in the State, comply with opening and closing inspection requirements in order to:
(a)
Commence operations at the new establishment location; and
(b)
Cease operations at the existing establishment location; and
(3)
If located outside the State, submit an inspection report for the new location conducted by the authorized entity in the state in which the establishment is located, or provide documentation of supplemental accreditation, if applicable.
Regulation .05 Change of Information Provided in Applications.LinkCopy Citation
Notwithstanding any other reporting requirements, a permit holder shall provide written notification to the Board at least 30 days prior to any change in information in its application provided to the Board, to include:
A.
Change in hours of operation; or
B.
Change in the physical structure of the establishment, to include any:
(1)
Deviation from the floorplan submitted by the permit holder as part of the application; or
(2)
Other change that may affect the security or storage conditions of prescription drugs or devices.
Regulation .06 Incomplete Applications.LinkCopy Citation
A.
The Board may hold an incomplete initial or reinstatement application for a license, registration, or permit for up to one year from the date of receipt.
B.
After 1 year from the date of receipt, the Board shall close a pending application that is incomplete.
C.
If an application has been closed under §B of this regulation, the applicant shall submit a new application fee and otherwise comply with all applicable license, registration, or permit requirements.
D.
If an applicant presents extenuating circumstances to the Board, the Board may, in its sole discretion, extend the 1-year application completion period.
Chapter annotations
Authority: Health Occupations Article, §§12-205 and 12-206, Annotated Code of Maryland
History: Effective date: November 10, 2003 (30:22 Md. R. 1582)
History: Regulation .01 amended effective July 8, 2013 (40:13 Md. R. 1076)
History: Regulation .01-1 adopted effective July 8, 2013 (40:13 Md. R. 1076)
History: Chapter revised effective May 20, 2019 (46:10 Md. R. 489)