(a)
(1)As provided in this section, all facilities licensed by the board shall complete the self-assessment process by July 1 of every odd-numbered year, unless otherwise established in this section.
(2)The self-assessment process shall be completed on a form provided by the board pursuant to this section.
(b)The form shall be completed to assess the facility’s compliance with federal and state laws identified on the form. For each “no” response, the facility shall undertake a written corrective action or action plan to come into compliance with the law.
(c)
(1)The form shall be signed under penalty of perjury by the designated individual, pursuant to this section, and cosigned by the owner or authorized officer of the facility acknowledging they have read, reviewed, and completed the
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(a)
(1)
As provided in this section, all facilities licensed by the board shall complete the self-assessment process by July 1 of every odd-numbered year, unless otherwise established in this section.
(2)
The self-assessment process shall be completed on a form provided by the board pursuant to this section.
(b)
The form shall be completed to assess the facility’s compliance with federal and state laws identified on the form. For each “no” response, the facility shall undertake a written corrective action or action plan to come into compliance with the law.
(c)
(1)
The form shall be signed under penalty of perjury by the designated individual, pursuant to this section, and cosigned by the owner or authorized officer of the facility acknowledging they have read, reviewed, and completed the self-assessment to the best of their professional ability and acknowledge that failure to correct any deficiency identified could result in action by the board.
(2)
The completed form shall be kept on file in the facility and made available to the board or its designee upon request.
(d)
The facility shall use the appropriate designated form based on the type of license, as described in this subdivision and as posted on the board’s internet website.
(1)
The Community Pharmacy Self-Assessment/Hospital Outpatient Self-Assessment form shall be completed by the pharmacist-in-charge. In addition to the requirements in subdivision (a), the form shall be completed within 30 days of any of the following:
(A)
A new pharmacy license is issued.
(B)
There is a change of pharmacist-in-charge, and they become the new pharmacist-in-charge of a pharmacy.
(C)
There is a change in the location of a pharmacy to a new address.
(2)
The Hospital Pharmacy Self-Assessment form shall be completed by the pharmacist-in-charge. In addition to the requirements in
subdivision (a), the form shall be completed within 30 days of any of the following:
(A)
A new pharmacy license is issued.
(B)
There is a change of pharmacist-in-charge, and they become the new pharmacist-in-charge of a pharmacy.
(C)
There is a change in the location of a pharmacy to a new address.
(3)
The Automated Drug Delivery System Self-Assessment form shall be completed by the pharmacist-in-charge of the pharmacy operating the system. In addition to the requirements in subdivision (a), the form shall be completed within 30 days of any of the following:
(A)
A new pharmacy license is
issued.
(B)
There is a change of pharmacist-in-charge, and they become the new pharmacist-in-charge of a pharmacy.
(C)
There is a change in the location of a pharmacy to a new address.
(4)
The Compounding Self-Assessment form shall be completed by the pharmacist-in-charge of each pharmacy that compounds drug products. In addition to the requirements in subdivision (a), the form shall be completed within 30 days of any of the following:
(A)
A new pharmacy license is issued.
(B)
There is a change of pharmacist-in-charge, and they become the new pharmacist-in-charge of a pharmacy.
(C)
There is a change in the location of a pharmacy to a new address.
(5)
The Surgical Clinic Self-Assessment form shall be completed by the consulting pharmacist of the surgical clinic and cosigned by the professional director.
(6)
The Wholesaler/Third-Party Logistics Provider Self-Assessment form shall be completed by the designated representative-in-charge or the wholesaler or responsible manager of the third-party logistics provider. In addition to the requirements in subdivision (a), the form shall be completed within 30 days of any of the following:
(A)
A new license is issued.
(B)
There is
a change of designated representative-in-charge or responsible manager, and they become the new designated representative-in-charge or responsible manager.
(C)
There is a change in the location to a new address.
(7)
The Outsourcing Facility Self-Assessment form shall be completed by the designated quality control personnel. In addition to the requirements in subdivision (a), the form shall be completed within 30 days of any of the following:
(A)
A new license is issued.
(B)
There is a change in the designated quality control personnel.
(C)
There is a change in the location to a new
address.