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WA Pharmacy Quality Assurance Commission
2020 Responsible Pharmacy Manager
Pharmacy Self-Inspection Worksheet
USP 795 – Nonsterile Compounding Addendum
ATTENTION: Responsible Pharmacy Manager
Washington law holds the responsible manager and all pharmacists on duty responsible for ensuring pharmacy compliance with
all state and federal laws governing the practice of pharmacy. Failure to complete this report within the month of March or within
30 days of becoming responsible manager (as required by WAC 246-945-005) may result in disciplinary action. The following
addendum is required to be filled out and kept on file with the General Pharmacy Self-Inspection Worksheet. Do not
send to the Commission office.
The primary objective of this report, and your self-inspection, is to provide an opportunity to identify and correct areas of non-
compliance with state and federal law. This worksheet does not replace U.S. Pharmacopeia (USP) <795> Pharmaceutical
Compounding – Sterile Preparations. (NOTE: Neither the self-inspection nor a Commission inspection evaluates your complete
compliance with all laws and rules of the practice of pharmacy.)
By answering the questions and referencing the appropriate laws/rules/CFR provided, you can determine whether you are
compliant with many of the rules and regulations. If you have corrected any deficiencies, please write corrected and the date of
correction by the appropriate question.
For additional guidance on the self-inspection addendum, please see Guidance Document #61 – United States
Pharmacopeia General Chapter <795> - Nonsterile Compounding – Information.
Date responsible manager/change of responsible manager inspection was performed:
Signature of responsible pharmacy manager:
Questions highlighted in blue are questions that will be focused on during routine pharmacy inspections.
DOH 690-326 (June 2020)
USP 795 Non-sterile Compounding Self-Inspection Addendum
General Rule Reference - Applies to all questions through worksheet.
RCW 18.64.270(2) "Any medicinal products that are compounded for patient administration or distribution to a licensed practitioner for patient use or
administration shall, at a minimum, meet the standards of the official United States pharmacopeia as it applies to nonsterile products and sterile
administered products."
Compliant Rule Reference Notes/Corrective Actions
Yes No N/A #
Training & Training Procedures
USP Chapter 795 Categories of Compounding -
"Compounders shall acquire and maintain knowledge
and skills in all areas (e.g. dosage, form, patient
Are all licensed pharmacy population, and medical specialty) for which they
personnel involved in compound.
compounding properly trained for
1 USP Chapter 795 - Training "All personnel involved in
the type of compounding they the compounding, evaluation, packaging, and dispensing
perform? of compounded preparations shall be properly trained for
the type of compounding conducted. It is the responsibility
*USP recommends annual of the compounder to ensure that a training program has
evaluations of personnel been implemented and that it is ongoing. "
training.* *Compounder in this reference can be either a
pharmacist or a pharmacy technician.*
USP Chapter 795 - "Steps in the training procedure
include the following:
Do training procedures require all • All employees involved in pharmaceutical compounding
2 pharmacy personnel who shall read and become familiar with this chapter. They
compound to read and be familiar should also be familiar with the contents of the USP
with ? Pharmacists' Pharmacopeia and other relevant
publications, including how to read and interpret
MSDSs."
USP Chapter 795 - "Steps in the training procedure
Do training procedures require all include the following:
pharmacy personnel who • All employees shall read and become familiar with
3
compound to read and be familiar each of the procedures related to compounding,
with your pharmacy's procedures including those involving the facility, equipment,
related to compounding? personnel, actual compounding, evaluation,
packaging, storage, and dispensing."
DOH 690-326 (June 2020)
USP 795 Non-sterile Compounding Self-Inspection Addendum
Compliant Rule Reference Notes/Corrective Actions
Yes No N/A #
USP Chapter 795 - "Steps in the training procedure
Do training procedures include include the following:
4 hazardous drug training if All personnel who compound hazardous drugs shall be
hazardous drugs are handled in fully trained in the storage, handling, and disposal of
the pharmacy? these drugs. This training shall occur before preparing or
handling hazardous drugs."
USP Chapter 795 - "Steps in the training procedure
include the following:
Do training procedures require all • All training activities shall be documented. The
5 training activities to be documented compounder shall meet with employees to review their
by the responsible manager? work and answer any questions the employees may have
concerning compounding procedures."
Do training procedures include the USP Chapter 795 - Training "Steps in the training
following? procedure include
the following:
USP Chapter 795 - Training "• The compounder shall
demonstrate the procedures for the employee and shall
observe and guide the employee throughout the training
process. The employee will then repeat the procedure
without any assistance from, but under the direct
supervision of, the compounder.
Demonstration and observation
a of proper procedures and • When the employee has demonstrated to the
knowledge of procedures. compounder a verbal and functional knowledge of the
procedure, then and only then will the employee be
permitted to perform the procedure without direct
6 supervision. However, the compounder should be
physically present and shall approve all ingredients and
their quantities and the final preparation."
*Compounder in this reference can be either a
pharmacist or a pharmacy technician.*
USP Chapter 795 - Training "• When the compounder is
satisfied with the employee’s knowledge and proficiency,
Requiring signatures on the compounder will sign the documentation records to
b training documentation show that the employee was appropriately trained."
*Compounder in this reference can be either a
pharmacist or a pharmacy technician.*
DOH 690-326 (June 2020)
USP 795 Non-sterile Compounding Self-Inspection Addendum
Compliant Rule Reference Notes/Corrective Actions
Yes No N/A #
USP Chapter 795 - "Steps in the training procedure
include the following:
Pharmacist monitoring of • The compounder shall continually monitor the work of the
c employees work employee and ensure that the employee's calculations
and work are accurate and adequately performed."
*Compounder in this reference means a pharmacist.*
USP Chapter 795 - "Steps in the training procedure
include the following:
6 d Pharmacist responsibility for • The compounder is solely responsible for the finished
final preparation preparation."
*Compounder in this reference means a pharmacist.*
Compounding Process
In the Rule References for Questions 7 -18 "compounder" can be either a pharmacist or a pharmacy technician, however the final check is the
responsibility of a pharmacist.
USP Chapter <795> The compounder is responsible
for ensuring that each individual incidence of
Do employees engaged in compounding meets the criteria given in this section.
7 compounding check to ensure that 1. The dose, safety, and intended use of the preparation
the dose, safety, and intended use or device has been evaluated for suitability in terms of: •
of the product or preparation has the chemical and physical properties of the components
been evaluated for suitability? • dosage form • therapeutic appropriateness and route
of administration, including local and systemic biological
disposition • legal limitations, if any.
USP Chapter 795 - Compounding Process - "The
compounder is responsible for ensuring that each
individual incidence of compounding meets the criteria
Do employees engaged in given in this section.
8 compounding check ingredients to 3. Ingredients used in the formulation have their expected
be used in the preparation have
identity, quality, and purity. If the formulation is for
their expected identity, quality, and humans, ingredients are not on a list of federally
purity? recognized drugs or specific drug products that have
been withdrawn or removed from the market for safety or
efficacy reasons (see www.FDA.gov) "
DOH 690-326 (June 2020)
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