Licensing Requirements. A community pharmacy engaged in the
compounding of sterile preparations shall be designated as a Class
A-S pharmacy.
(1) A Class A-S pharmacy shall register annually or
biennially with the board on a pharmacy license application provided
by the board, following the procedures as specified in §291.1
of this title (relating to Pharmacy License Application). A Class
A-S license may not be issued unless the pharmacy has been inspected
by the board to ensure the pharmacy meets the requirements as specified
in §291.133 of this title (relating to Pharmacies Compounding
Sterile Preparations).
(2) A Class A-S pharmacy may not renew a pharmacy license
unless the pharmacy has been inspected by the board within the last
renewal period.
(3) A Class A-S pharmacy which changes ownership shall
notify the board within ten days of the change of ownership and apply
for a new and separate license as specified in §291.3 of this
title (relating to Required Notifications).
(4) A Class A-S pharmacy which changes location and/or
name shall notify the board within ten days of the change and file
for an amended license as specified in §291.3 of this title.
(5) A Class A-S pharmacy owned by a partnership or
corporation which changes managing officers shall notify the board
in writing of the names of the new managing officers within ten days
of the change, following the procedures as specified in §291.3
of this title.
(6) A Class A-S pharmacy shall notify the board in
writing within ten days of closing, following the procedures as specified
in §291.5 of this title (relating to Closing a Pharmacy).
(7) A separate license is required for each principal
place of business and only one pharmacy license may be issued to a
specific location.
(8) A fee as specified in §291.6 of this title
(relating to Pharmacy License Fees) will be charged for the issuance
and renewal of a license and the issuance of an amended license.
(9) A Class A-S pharmacy which would otherwise be required
to be licensed under the Act, §560.051(a)(1) concerning Community
Pharmacy (Class A) is required to comply with the provisions of §291.31
of this title (relating to Definitions), §291.32 of this title
(relating to Personnel), §291.33 of this title (relating to Operational
Standards), §291.34 of this title (relating to Records), §291.35
of this title (relating to Official Prescription Requirements), and §291.133
of this title.
(10) A Class A-S pharmacy engaged in the compounding
of non-sterile preparations shall comply with the provisions of §291.131
of this title (relating to Pharmacies Compounding Non-Sterile Preparations).
(11) A Class A-S pharmacy engaged in the provision
of remote pharmacy services, including storage and dispensing of prescription
drugs, shall comply with the provisions of §291.121 of this title
(relating to Remote Pharmacy Services).
(12) A Class A-S pharmacy engaged in centralized prescription
dispensing and/or prescription drug or medication order processing
shall comply with the provisions of §291.123 of this title (relating
to Centralized Prescription Drug or Medication Order Processing) and/or §291.125
of this title (relating to Centralized Prescription Dispensing).
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