Licensing requirements. An institutional or ASC pharmacy engaged
in the compounding of sterile preparations shall be designated as
a Class C-S pharmacy.
(1) A Class C-S pharmacy shall register annually or
biennially with the board on a pharmacy license application provided
by the board, following the procedures specified in §291.1 of
this title (relating to Pharmacy License Application). A Class C-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 C-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 C-S pharmacy which changes ownership shall
notify the board within 10 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 C-S pharmacy which changes location and/or
name shall notify the board within 10 days of the change and file
for an amended license as specified in §291.3 of this title.
(5) A Class C-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 10 days
of the change following the procedures in §291.3 of this title.
(6) A Class C-S pharmacy shall notify the board in
writing within 10 days of closing, following the procedures in §291.5
of this title (relating to Closing a Pharmacy).
(7) 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.
(8) A separate license is required for each principal
place of business and only one pharmacy license may be issued to a
specific location.
(9) A Class C-S pharmacy, licensed under the Act, §560.051(a)(3),
which also operates another type of pharmacy which would otherwise
be required to be licensed under the Act, §560.051(a)(1) (Community
Pharmacy (Class A)) or the Act, §560.051(a)(2) (Nuclear Pharmacy
(Class B)), is not required to secure a license for the such other
type of pharmacy; provided, however, such licensee 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), and §291.35 of this title (relating
to Official Prescription Requirements), contained in Community Pharmacy
(Class A), or §291.51 of this title (relating to Purpose), §291.52
of this title (relating to Definitions), §291.53 of this title
(relating to Personnel), §291.54 of this title (relating to Operational
Standards), and §291.55 of this title (relating to Records),
contained in Nuclear Pharmacy (Class B), to the extent such sections
are applicable to the operation of the pharmacy.
(10) A Class C-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 C-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 C-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 Central Prescription Drug or Medication Order Processing) and/or
§291.125 of this title (relating to Centralized Prescription
Dispensing).
(13) A Class C-S pharmacy with an ongoing clinical
pharmacy program that proposes to allow a pharmacy technician to verify
the accuracy of work performed by another pharmacy technician relating
to the filling of floor stock and unit dose distribution systems for
a patient admitted to the hospital if the patient's orders have previously
been reviewed and approved by a pharmacist shall make application
to the board as follows.
(A) The pharmacist-in-charge must submit an application
on a form provided by the board, containing the following information:
(i) name, address, and pharmacy license number;
(ii) name and license number of the pharmacist-in-charge;
(iii) name and registration numbers of the pharmacy
technicians;
(iv) anticipated date the pharmacy plans to begin allowing
a pharmacy technician to verify the accuracy of work performed by
another pharmacy technician;
(v) documentation that the pharmacy has an ongoing
clinical pharmacy program; and
(vi) any other information specified on the application.
(B) The pharmacy may not allow a pharmacy technician
to check the work of another pharmacy technician until the board has
reviewed and approved the application and issued an amended license
to the pharmacy.
(C) Every two years, in connection with the application
for renewal of the pharmacy license, the pharmacy shall provide updated
documentation that the pharmacy continues to have an ongoing clinical
pharmacy program as specified in subparagraph (A)(v) of this paragraph.
(14) A rural hospital that wishes to allow a pharmacy
technician to perform the duties specified in §291.73(e)(2)(D)
of this title (relating to Personnel) shall make application to the
board as follows.
(A) Prior to allowing a pharmacy technician to perform
the duties specified in §291.73(e)(2)(D) of this title, the pharmacist-in-charge
must submit an application on a form provided by the board, containing
the following information:
(i) name, address, and pharmacy license number;
(ii) name and license number of the pharmacist-in-charge;
(iii) name and registration number of the pharmacy
technicians;
(iv) proposed date the pharmacy wishes to start allowing
pharmacy technicians to perform the duties specified in §291.73(e)(2)(D)
of this title;
(v) documentation that the hospital is a rural hospital
with 75 or fewer beds and that the rural hospital is either:
(I) located in a county with a population of 50,000
or less as defined by the United States Census Bureau in the most
recent U.S. census; or
(II) designated by the Centers for Medicare and Medicaid
Services as a critical access hospital, rural referral center, or
sole community hospital; and
(vi) any other information specified on the application.
(B) A rural hospital may not allow a pharmacy technician
to perform the duties specified in §291.73(e)(2)(D) of this title
until the board has reviewed and approved the application and issued
an amended license to the pharmacy.
(C) Every two years in conjunction with the application
for renewal of the pharmacy license, the pharmacist-in-charge shall
update the application for pharmacy technicians to perform the duties
specified in §291.73(e)(2)(D) of this title.
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