Current through September 24, 2024
1. The person who
signs the application for a pharmacy permit or the renewal of a pharmacy permit
shall be the pharmacist-in-charge (PIC) for that facility.
A. Authority. The PIC of the pharmacy shall
be responsible for complete supervision, management and compliance with all
federal and state pharmacy laws and regulations pertaining to the practice of
pharmacy in the entire prescription department. He/She shall have the
cooperation and support of all pharmacy staff in carrying out these
responsibilities. The pharmacist-in-charge is responsible for assuring that all
personnel are properly registered or licensed with the Board and that all
pharmacy permits are current and appropriate for the type of pharmacy operation
being conducted. A pharmacist shall not be the PIC at more than one Community
Pharmacy or Institutional I Pharmacy (unless the Board grants a waiver upon
presentation of good cause) and shall not be the pharmacist-in-charge or have
personal supervision of more than one facility which is open to the general
public on a full-time basis.
B.
Responsibilities of the Pharmacist-in-Charge:
(1) That each individual workspace is
designed to provide space and a workflow design that will accommodate the
workload in an organized fashion; and
(2) That the computer's software should be of
a design so that drug interactions and contraindications must be reviewed by
the pharmacist. Further, the computer system should support counseling and drug
utilization review documentation; and
(3) That trained supportive staff shall be
maintained to meet the demands of the practice site, workload and the clientele
served; and
(4) That all staff
should be afforded and encouraged to participate in training and continuing
education in order to keep them abreast of new information and changes in the
field; and
(5) That if quotas or
formulas such as prescription volume are used to set staffing, conditions such
as peak workload periods, workplace design and the training of staff must be
taken into consideration.
(6) A PIC
shall be required to be physically onsite at the pharmacy a minimum of twenty
(20) hours per work week or fifty per cent (50%) of the hours of operation of
the pharmacy, whichever is less. A record of the onsite hours of the PIC shall
be produced upon request by the Board or an agent of the Board. Exceptions will
be recognized for practical reasons, i.e., vacation, sick time,
etc...
C. Circumvention.
It is a violation of this section for any person to subvert the authority of
the pharmacist-in-charge by impeding the management of the prescription
department for the compliance with federal and state drug or pharmacy laws and
regulations. Any such circumvention may result in charges being filed against
the pharmacy permit.
2.
A permit for a pharmacy shall not be issued or renewed unless the
pharmacist-in-charge is licensed in this state. If the pharmacist license of
the pharmacist-in-charge becomes void or inactive due to surrender, revocation,
suspension, restriction or for any other reason, application must be made for a
new pharmacy permit by another pharmacist within fifteen (15) days. Failure to
submit an application for a new PIC within fifteen (15) days shall render the
permit inactive and the pharmacy shall cease doing business in the state until
a new permit is issued to a new PIC.
3. If the employment of a
pharmacist-in-charge is terminated or if for any other reason he/she wishes to
be relieved of the responsibilities of the PIC, he/she must:
A. Return the permit to the Mississippi Board
of Pharmacy with written notice that he/she is no longer the
pharmacist-in-charge for that facility and;
B. In accordance with the provision of
paragraph 2 of ARTICLE XXV of the Regulations, send to the Board of Pharmacy an
inventory of any controlled substances on hand at the facility at the time of
his/her termination as pharmacist-in-charge.
C. When the relinquishing PIC cannot or does
not comply with the inventory requirements of this paragraph it shall be the
responsibility of the new PIC to send to the Board of Pharmacy an inventory of
any controlled substances on hand at the time he/she assumes responsibility as
PIC.
D. The relinquishing PIC is
responsible for notification of appropriate supervisors or owners of the
surrender of the permit. When a permit is thus returned for a facility,
application for a new permit for that facility must be made to the Mississippi
Board of Pharmacy within fifteen (15) days.
4. If a permitted facility is permanently
closed or has a change of ownership, the pharmacist-in charge for that facility
shall give notice to the Board of the effective date of closure or change in
ownership and include the storage location of the business's records and
appropriate contact information. If a permitted facility has a change in name
or location, application for a new permit must be made to the Board at least
fifteen (15) days prior to the change in name or location. Once issued, a
permit cannot be amended, transferred or assigned to another person.
5. On the premises where a pharmacy is
maintained in conjunction with other services or business activities, the
pharmacy shall be physically secured from such other services or activities
during those times a pharmacist is not present and the pharmacy is not open,
and other services or activities are being provided on the premises.
A. The Pharmacy shall be secured by a
physical barrier to detect entry at a time when the Pharmacist is not present.
B. Each pharmacist while on duty
shall be responsible for the security of the Pharmacy, including provisions for
effective control against theft or diversion of Drugs and/or Devices.
C. The pharmacist-in-charge shall be
responsible for adequate security being maintained on drugs in all areas of the
permitted facility at all times and is responsible for reporting any loss or
suspected loss of controlled substances or legend drugs directly to the Board
immediately (this does not relieve any pharmacist who discovers a loss from the
requirement of reporting the loss directly to the Board).
6. Each facility issued a pharmacy permit by
the Mississippi Board of Pharmacy shall maintain:
A. An area of sufficient size to accommodate
the dispensing functions of the facility and which is adequately equipped to
provide for the proper storage of drugs and supplies under appropriate
conditions of temperature, light, moisture, sanitation, ventilation and
security. All areas where Drugs and Devices are stored shall be dry, well
lighted, well ventilated, and maintained in a clean and orderly condition.
Storage areas shall be maintained at temperatures which will ensure the
integrity of the Drugs prior to their dispensing as stipulated by the USP-NF
and/or the Manufacturer's or Distributor's labeling.
B. A sink with hot and cold running water
which is convenient to the dispensing area;
C. An inventory which shall include such
drugs, chemicals and preparations as may be necessary to fill ordinary
prescriptions as indicated by experience in the area where the pharmacy is
located;
D. Technical equipment
which may include measuring graduates, mortar and pestle, spatulas, funnels,
ointment slab or paper, balance and such other items of equipment found to be
necessary for the filling of prescriptions or rendering of other pharmacist
services; and,
E. Current
reference material adequate for professional and consumer
information.
F. Pharmacy permits,
facility-controlled substance registrations, and DEA registrations must be
conspicuously posted. Evidence of current pharmacist licensure and pharmacy
technician registration must be provided on request by any agent of the Board.
G. A current and updated copy of
the Mississippi Board of Pharmacy Practice Regulations and Pharmacy Practice
Act.
7. It is the
responsibility of the Pharmacist-in-charge to establish and implement
procedures to ensure compliance with the Article entitled Prescription
Monitoring Program.
8. The
pharmacist-in-charge shall be responsible for written policies and procedures
for maintaining the integrity and confidentiality of prescription and patient
health care information. All employees of the pharmacy with access to any such
information shall be required to read, sign, and comply with the established
policies and procedures.