Attachment C VHA Directive 1108.12.pdf

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Department of Veterans Affairs VHA DIRECTIVE 1108.12 Veterans Health Administration Transmittal Sheet Washington, DC 20420 FEBRUARY 14, 2024

MANAGEMENT AND MONITORING OF PHARMACEUTICAL COMPOUNDED

PREPARATIONS

1. SUMMARY OF MAJOR CHANGES: Major changes include:

a. Updates the policy statement to include language that specifies the conditions under which compounding processes should be completed in paragraph 1.

b. Updates responsibilities in paragraph 2 for the Assistant Under Secretary for Patient Care Services/Chief Nursing Officer, the Assistant Under Secretary for Health for Operations, the Chair of the VHA National Pharmacy Compounding Advisory committee, Veterans Integrated Service Network Director, Chair of the VISN Pharmacy Compounding Advisory Committee, VA medical facility Director, the Facility Compounding Advisory Committee Chair, the VA medical facility Chief of Pharmacy Service, the VA medical facility Designated Compounding Pharmacist, the VA medical facility Nurse Executive, the VA medical facility Chief of Engineering and the VA medical facility Chief of Environmental Management Services (EMS).

c. Includes responsibilities for the Assistant Under Secretary for Health for Support Services, Assistant Undersecretary for Health for Quality and Patient Safety and Assistant Under Secretary for Health for Clinical Services/Chief Medical Officer.

d. Updates the roles for committee leadership and committee names in paragraphs 2.h., 2.k. and 2.m.

e. Clarifies and reinforces the conditions under which compounding can take place at VA pharmacies in paragraph 1, paragraph 2.n.9., and paragraph 3.

f. Updates the background in paragraph 8.

g. Includes definitions for classified area, release inspection and testing and unclassified space in paragraph 9.f., 9.r. and 9.x.

h. Includes Appendix B, Additional Resources.

2. RELATED ISSUES: VHA Directive 1148, Allergen Therapy and Allergen Immunotherapy Clinics, dated June 28, 2022; VHA Directive 1850.05 Interior Design Operations and Management Program, dated September 22, 2017; VHA Directive 7702, Industrial Hygiene Exposure Assessment Program, dated July 29, 2021; and VHA Directive 7707, VHA Green Environmental Management System (GEMS) & Governing Environmental Policy Statement, dated April 1, 2021.

3. POLICY OWNER: The Executive Director, Pharmacy Benefits Management (12PBM) Services in the Office of Patient Care Services, is responsible for the content of this directive. Questions may be referred to VHA Pharmacy Benefit Management National Compounding Advisory Committee at: VHAPBMUSP797Committee@va.gov.

mailto:VHAPBMUSP797Committee@va.gov

FEBRUARY 14, 2024 VHA DIRECTIVE 1108.12

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4. RESCISSIONS: VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Preparations, November 5, 2018.

5. RECERTIFICATION: This VHA directive is scheduled for recertification on or before the last working day of February 2029. This VHA directive will continue to serve as national VHA policy until it is recertified or rescinded.

6. IMPLEMENTATION SCHEDULE: This directive is effective upon publication.

BY DIRECTION OF THE OFFICE OF

THE UNDER SECRETARY FOR HEALTH:

/s/ M. Christopher Saslo, DNS, APRN-BC, FAANP

Assistant Under Secretary for Health for Patient Care Services/CNO

NOTE: All references herein to VA and VHA documents incorporate by reference subsequent VA and VHA documents on the same or similar subject matter.

DISTRIBUTION: Emailed to the VHA Publication Distribution List on February 14, 2024.

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CONTENTS

MANAGEMENT AND MONITORING OF PHARMACEUTICAL COMPOUNDED

PREPARATIONS

1. POLICY

2. RESPONSIBILITIES

3. STERILE COMPOUNDING

4. NON-STERILE COMPOUNDING

5. OUTSOURCING COMPOUNDED PREPARATIONS

6. TRAINING

7. RECORDS MANAGEMENT

8. BACKGROUND

9. DEFINITIONS

10. REFERENCES

APPENDIX A

DEFINING, CERTIFYING AND PROCURING PRIMARY ENGINEERING CONTROLS

FOR COMPOUNDED STERILE PREPARATIONS ........................................................ A-1

APPENDIX B

ADDITIONAL RESOURCES............................................................................................. B-1

MANAGEMENT AND MONITORING OF PHARMACEUTICAL COMPOUNDED

PREPARATION

1. POLICY

It is Veterans Health Administration (VHA) policy that each Department of Veterans Affairs (VA) medical facility providing compounded preparations have a pharmaceutical compounding program in place for compounding sterile and non-sterile preparations and handling hazardous drugs in health care and clinical research settings established in the United States Pharmacopeia (USP). NOTE: VHA does not prepare compounded preparations that require sterility and stability testing. AUTHORITY: 38 U.S.C. § 7301(b).

2. RESPONSIBILITIES

a. Under Secretary for Health. The Under Secretary for Health is responsible for ensuring overall VHA compliance with this directive.

b. Assistant Under Secretary for Health for Patient Care Services/Chief Nursing Officer. The Assistant Under Secretary for Health for Patient Care Services/Chief Nursing Officer is responsible for:

(1) Supporting Pharmacy Benefits Management (PBM) with implementation and oversight of this directive.

(2) Ensuring that PBM is appropriately resourced to perform duties and responsibilities assigned in this directive.

(3) Ensuring collaboration across the patient care and operational programs to achieve success in the goals and intent of this directive.

(4) Providing governance leadership and management of compounding programs.

(5) Providing leadership for proactive, recurring compounding reviews.

(6) Communicating enterprise-wide initiatives that may impact quality and patient safety programs, processes and practices associated with compounding and compounded preparations.

(7) Ensuring distribution of relevant compounding program procedural requirements, correspondence and guidance.

(8) Establishing a multidisciplinary VHA National Compounding Advisory Committee comprised of the United States Pharmacopeia (USP) <795>, <797> and <800> subject matter experts (SMEs).

(9) Collaborating with other Assistant Under Secretaries for Health in supporting the recommendations and actions of the National Compounding Advisory Committee.

c. Assistant Under Secretary for Health for Operations. The Assistant Under Secretary for Health for Operations (AUSH Operations) is responsible for:

(1) Communicating the contents of this directive to each of the Veterans Integrated Service Networks (VISNs).

(2) Assisting VISN Directors to resolve implementation and compliance challenges in all VA medical facilities within that VISN.

(3) Providing oversight of VISNs to ensure compliance with this directive and its effectiveness.

d. Assistant Under Secretary for Health for Support Services. The Assistant Under Secretary for Health for Support Services is responsible for collaborating with other Assistant Under Secretaries for Health in supporting the recommendations and actions of the National Compounding Advisory Committee.

e. Assistant Under Secretary for Health for Quality and Patient Safety. The Assistant Undersecretary for Health for Quality and Patient Safety is responsible for collaborating with other Assistant Under Secretaries for Health in supporting the recommendations and actions of the National Compounding Advisory Committee.

f. Assistant Under Secretary for Health for Clinical Services/Chief Medical Officer. The Assistant Under Secretary for Health for Clinical Services/Chief Medical Officer is responsible collaborating with other VHA Assistant Under Secretaries for Health in supporting the recommendations and actions of the National Compounding Advisory Committee.

g. Executive Director, Pharmacy Benefits Management Services. The Executive Director of Pharmacy Benefits Management (PBM) is responsible for:

(1) Ensuring Pharmacy SMEs provide policy and guidance related to all aspects of compounding and outsourcing practices, including interpretation of USP compounding chapters and understanding and application of Federal law.

(2) Ensuring Pharmacy compounding SMEs participate and serve as co-chairs for the VHA National Compounding Advisory Committee.

(3) Ensuring Pharmacy SMEs represent VHA as points of contact to outside regulatory and accreditation organizations for topics related to compounding.

h. Chair, VHA National Pharmacy Compounding Advisory Committee. The Chair of the VHA National Pharmacy Compounding Advisory Committee is responsible for:

(1) Providing consultative services to VISN and VA facility leadership in cleanroom design, environmental controls and monitoring, and core competencies. The committee membership must at a minimum include SME representatives from the VHA Office of Quality and Patient Safety, Pharmacy Benefits Management (PBM) Services, Healthcare Environment and Facilities (Engineering, Industrial Hygienist and Environmental Management Services), Occupational Safety and Health (OS&H), National Infectious Diseases Service (NIDS). Nursing, Biomedical Engineering, Green Environmental Management Systems (GEMS), and other representatives will be included on an ad hoc basis as appropriate.

(2) Reviewing VA medical facility compounding space design, construction and remodel plans at 30%, 60% and 90% design stages and prior to execution to ensure each space meets the requirements for compounding spaces.

(3) Developing national procedural requirements for VISN and VA medical facilities on issues related to pharmaceutical compounding.

i. Director, National Allergy and Immunology Program in the Specialty Care Program Office. The Director National Allergy and Immunology Program in the Specialty Care Program Office is responsible for ensuring compliance with all USP <797> standards associated with the provision of compounded allergenic extracts as required by VHA Directive 1148, Allergen Therapy and Allergen Immunotherapy Clinics, dated June 28, 2022.

j. Veterans Integrated Service Network Director. The VISN Director is responsible for:

(1) Ensuring that all VA medical facilities within the VISN comply with this directive and informing leadership when barriers to compliance are identified.

(2) Establishing a multidisciplinary VISN Pharmacy Compounding Advisory Committee that includes USP compounding subject matter experts capable of providing consultative services to VISN and VA medical facility leadership in cleanroom design environmental controls and monitoring and core competencies. The committee membership must be chaired by a member of the VISN executive leadership team and co-chaired by the VISN Pharmacist Executive and at a minimum include: VISN Quality Manager, Executive Engineering Service, Industrial Hygienist, Environmental Management Services, Occupational Safety and Health (OS&H) and Infection Prevention and Control. Nursing, Biomedical Engineering, GEMS, and other representatives will be included on an ad hoc basis as appropriate.

(3) Ensuring that the VISN Pharmacist Executive co-chair actively participates in setting the agenda and provides content to ensure the committee addresses topics relevant and necessary for facility end-users.

(4) Informing the VHA National Pharmacy Compounding Advisory Committee of incidents with impact to Pharmacy Compounding Operations as defined in the Issue Brief Tracker Guidance: Curtailment Reporting Requirements, available at https://vssc.med.va.gov/IBTracker/Docs/Guide%20to%20Issue%20Briefs%20(Updated%2 04-6-22).pdf. NOTE: This is an internal VA website that is not available to the public.

(5) Ensuring that each facility reports any change in a VA medical facility’s compounding program using the Issue Brief process established by VHA Central Office.

The VISN Compounding Advisory Committee will ensure the VA medical facility corrective action plan(s) is consistent with requirements and identifies appropriate milestones and target dates.

https://vssc.med.va.gov/IBTracker/Docs/Guide%20to%20Issue%20Briefs%20(Updated%204-6-22).pdf https://vssc.med.va.gov/IBTracker/Docs/Guide%20to%20Issue%20Briefs%20(Updated%204-6-22).pdf

k. Chair, VISN Compounding Advisory Committee. The Chair of the VISN Pharmacy Compounding Advisory Committee is responsible for:

(1) Reviewing facility reports (e.g.CAPAs, IBs, certification reports) related to compounding compliance that adversely impact or may impact Veteran care or employee safety for the purposes of confirming compliance and advising on the resolution of noncompliance issues.

(2) Reviewing on an annual basis VA medical facility compounding contingency plans to ensure they are readily retrievable, can be operationalized and have been simulated to meet the needs of the facility.

(3) Reviewing the results of the certification reports to identify whether there were any environmental or engineering failures in the compounding spaces. Assist facilities with resolution of any identified failures

(4) Ensuring that VA medical facility corrective action plans created in response to Issue Briefs presented to the VISN Director pursuant to paragraph 2.j.(5) are consistent with requirements and identify appropriate milestones and target dates.

l. VA Medical Facility Director. The VA medical facility Director is responsible for:

(1) Ensuring overall VA medical facility compliance with this directive and that appropriate corrective action is taken if non-compliance is identified.

(2) Ensuring that the VA medical facility has the appropriate infrastructure for compounding programs.

(3) Ensuring that the VA medical facility complies with all elements associated with compounding programs.

(4) Establishing a multidisciplinary VA medical facility Compounding Advisory Committee. The committee must be chaired by a member of the VA medical facility executive leadership team (i.e., Quadrad) and, at a minimum, include the Chief of Pharmacy (or designee), Designated Compounding Pharmacist, Quality Manager, Biomedical Engineering (ad hoc), Healthcare Environment and Facilities (Engineering, Industrial Hygienist [or alternate Occupational Safety and Health Service Manager] and Environmental Management Services), GEMS (ad hoc), and Infection Prevention and Control.

(5) Assisting the VA medical facility Compounding Advisory Committee Chair with development of a charter.

(6) Ensuring that the VA medical facility Compounding Advisory Committee meets no less frequently than quarterly and provides updates (e.g., minutes) or concerns as defined by the charter.

(7) Ensuring the Pharmacy Department has the necessary resources to employ a Designated Compounding Pharmacist(s) to provide oversight of the Pharmacy Department’s compliance with compounding requirements in accordance with all USP compounding standards (Chapters <797>,<800>, <795>).

(8) Ensuring that the VA medical facility Chief of Engineering Service uploads designs for any new construction or renovation of compounding spaces at 30%, 60%, and 90% completion on the SharePoint link (Design Review Requests) for review by the National Compounding Advisory Committee prior to execution. Modular and mobile unit procurements and leases must also be submitted for review by the National Compounding Advisory Committee prior to execution. See the Design Review Requests link here, https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fdvagov.sharepoint.

com%2Fsites%2FVACOVHADUSHOM%2F10NA%2F10NA5%2FHealthcareEngineering %2FPages%2FDesign%2520Review%2520Requests.aspx&data=05%7C01%7C%7C187 0e96920914d52e13b08da9295fe2b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C 0%7C637983470150034868%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAi LCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata= HEWFU5xRNrbV08nW8kGGK0BN8DJaC7IOXPJ%2F6pnbIx0%3D&reserved=0. NOTE:

This is an internal VA website that is not available to the public.

(9) Notifying the VISN Director of issues impacting compounding processes at the VA medical facility, using the Issue Brief process.

(10) Ensuring the VA medical facility compounding contingency plan is assessed annually, is operational, is retrievable, and has been simulated to meet the needs of the facility. NOTE: “Real life” events with documented after-action reviews may be utilized as documentation of simulation.

(11) Ensuring Primary Engineering Control (PEC) and Secondary Engineering Control (SEC) certification meets the requirements of USP standards and Controlled Environment Testing Association (CETA) controlled application guide (CAG) at least every 6 months.

NOTE: Contracts for such services may be maintained at the VISN or facility level.

m. Chair, VA Medical Facility Compounding Advisory Committee. The VA medical facility Compounding Advisory Committee Chair is responsible for:

(1) Collaborating with the VA medical facility Director to develop of a charter.

(2) Convening Committee meetings no less frequently than quarterly.

(3) Providing updates (e.g., minutes) or concerns as defined by the charter to the VA medical facility Director.

(4) Ensuring review of the CSP Safety and Quality Assurance (QA) plan by the VA medical facility Compounding Advisory Committee annually.

(5) Holding committee meetings on a minimum quarterly basis to review environmental controls and monitoring results, to ensure all appropriate staff has the core competencies necessary for handling CSPs and CNSPs, and for compliance with this Directive.

(6) Reporting issues impacting compounding processes at the VA medical facilities to the VA medical facility director and VISN Director using processes established by the VHA https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fdvagov.sharepoint.com%2Fsites%2FVACOVHADUSHOM%2F10NA%2F10NA5%2FHealthcareEngineering%2FPages%2FDesign%2520Review%2520Requests.aspx&data=05%7C01%7C%7C1870e96920914d52e13b08da9295fe2b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637983470150034868%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=HEWFU5xRNrbV08nW8kGGK0BN8DJaC7IOXPJ%2F6pnbIx0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fdvagov.sharepoint.com%2Fsites%2FVACOVHADUSHOM%2F10NA%2F10NA5%2FHealthcareEngineering%2FPages%2FDesign%2520Review%2520Requests.aspx&data=05%7C01%7C%7C1870e96920914d52e13b08da9295fe2b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637983470150034868%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=HEWFU5xRNrbV08nW8kGGK0BN8DJaC7IOXPJ%2F6pnbIx0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fdvagov.sharepoint.com%2Fsites%2FVACOVHADUSHOM%2F10NA%2F10NA5%2FHealthcareEngineering%2FPages%2FDesign%2520Review%2520Requests.aspx&data=05%7C01%7C%7C1870e96920914d52e13b08da9295fe2b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637983470150034868%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=HEWFU5xRNrbV08nW8kGGK0BN8DJaC7IOXPJ%2F6pnbIx0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fdvagov.sharepoint.com%2Fsites%2FVACOVHADUSHOM%2F10NA%2F10NA5%2FHealthcareEngineering%2FPages%2FDesign%2520Review%2520Requests.aspx&data=05%7C01%7C%7C1870e96920914d52e13b08da9295fe2b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637983470150034868%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=HEWFU5xRNrbV08nW8kGGK0BN8DJaC7IOXPJ%2F6pnbIx0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fdvagov.sharepoint.com%2Fsites%2FVACOVHADUSHOM%2F10NA%2F10NA5%2FHealthcareEngineering%2FPages%2FDesign%2520Review%2520Requests.aspx&data=05%7C01%7C%7C1870e96920914d52e13b08da9295fe2b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637983470150034868%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=HEWFU5xRNrbV08nW8kGGK0BN8DJaC7IOXPJ%2F6pnbIx0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fdvagov.sharepoint.com%2Fsites%2FVACOVHADUSHOM%2F10NA%2F10NA5%2FHealthcareEngineering%2FPages%2FDesign%2520Review%2520Requests.aspx&data=05%7C01%7C%7C1870e96920914d52e13b08da9295fe2b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637983470150034868%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=HEWFU5xRNrbV08nW8kGGK0BN8DJaC7IOXPJ%2F6pnbIx0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fdvagov.sharepoint.com%2Fsites%2FVACOVHADUSHOM%2F10NA%2F10NA5%2FHealthcareEngineering%2FPages%2FDesign%2520Review%2520Requests.aspx&data=05%7C01%7C%7C1870e96920914d52e13b08da9295fe2b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637983470150034868%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=HEWFU5xRNrbV08nW8kGGK0BN8DJaC7IOXPJ%2F6pnbIx0%3D&reserved=0 issue brief process.

(7) Ensuring that corrective action plans comply with applicable USP chapters, VHA requirements and applicable Federal law.

(8) Reviewing the VA medical facility compounding contingency plan and ensuring that it can be operationalized and has been simulated to meet the needs of the facility and submitting the plan to the VA facility director for review annually. NOTE: “Real life” events with documented after-action reviews may be utilized as documentation of simulation.

(9) Reviewing the results of environmental and engineering (state of control) certification reports (provided to the Pharmacy and Engineering Services by the contracted external CETA certified vendor) to determine if a corrective action plan is needed.

(10) Ensuring the situations that adversely impact or may impact Veteran care or employee safety are communicated to the VA medical facility Director to begin the issue brief process and VISN Compounding Advisory Committee for awareness.

(11) Reviewing plans for new construction or renovation of compounding spaces and modular and mobile unit procurements and ensuring that leases are submitted by the VA medical facility Director to the VISN Compounding Advisory Committee. NOTE: These plans must be reviewed by the National Compounding Advisory Committee at 30%, 60% and 90% design stages and prior to execution.

(12) Collaborate with the compounding advisory committee to evaluate certification failures, environmental control failures, or identification or exceedance of microbiological action levels as defined in the USP standards.

(13) Collaborate with the compounding advisory committee to develop and document corrective action and preventive action plans (CAPA).

(14) Ensure a quarterly report at a minimum is created and presented to the facility executive leadership team summarizing the activities of the Facility Compounding Advisory Committee.

n. Chief, VA Medical Facility Pharmacy Service. The VA medical facility Chief of Pharmacy Service is responsible for:

(1) Appointing full-time Designated Compounding Pharmacist(s). NOTE: The Designated Compounding Pharmacist duties cannot be assigned as collateral duties.

(2) Working with the Designated Pharmacist to develop a VA medical facility compounding contingency plan that may be activated to obtain compounded preparations through alternative means in situations where compounding preparations at the facility are suspended because the facility is unable to maintain a state of control is documented and communicated to necessary staff. VA medical facility compounding contingency plans must be tested annually to ensure the plan meets the operational needs of the facility. VA medical facility compounding contingency plans must take all precautions to not affect patient care. NOTE: “Real life” events with documented after-action reviews may be utilized as documentation of simulation.

(3) Collaborating with the VA medical facility Chief of Engineering Services to ensure appropriate selection and development of the statement of work (SOW) for contracted certification and environmental testing services and ensuring there is no lapse in services for this critical requirement.

(4) Prior to compounding a preparation, assessing the VA medical facility Pharmacy Service’s capability to compound CSPs and CNSPs that are not commercially available based on an evaluation of equipment, resources, environment, and competencies to prepare the compounded product.

(5) Collaborating with the VA medical facility Chief of Engineering Service to ensure USP and VA standards are incorporated in pharmacy compounding spaces including unclassified segregated compounding areas (SCAs) and containment segregated compounding areas (C-SCAs), cleanroom design, installation, renovation or other construction projects.

(6) Ensuring that Hazardous Drugs (HDs) that are transported, stored, and handled by other health care professionals are appropriately labeled to alert staff to handle the HDs as required by USP <800>.

(7) Ensuring that the pharmacy uses commercially available sterile admixtures and drug products or, when unavailable, commercially available therapeutic alternative drug products.

(8) Ensuring that the VA medical facility does not prepare compounded sterile products from any non-sterile components that require sterility performing procedures.

(9) Ensuring that all decisions for outsourcing compounded preparations are in alignment with VHA procedural requirements for outsourcing. For more information on pharmaceutical compounding management standards, see https://dvagov.sharepoint.com/sites/VHAPBM/Pharmacy_Operations/SitePages/Pharmac eutical-Compounding-and-Management-Standards.aspx. NOTE: This is an internal VA website that is not available to the public.

(10) Collaborating with the Chief of Environmental Management Services (EMS) through a formal Memorandum of Understanding (MOU) or departmental SOP that delineates the assignment of duties for the cleaning of pharmacy spaces. NOTE: For an MOU template, see http://vaww.hefp.va.gov/resources/eps-sanitation-procedure-guide.

This is an internal VA website that is not available to the public.

(11) Collaborating with the Chief of Environmental Management Services to review and approve non-VA contracts for cleaning services.

(12) Ensuring that training and competency processes are in place for any staff personnel involved in cleaning the primary and secondary engineering controls. NOTE:

This responsibility will be shared with the Chief of Environmental Management Services.

https://dvagov.sharepoint.com/sites/VHAPBM/Pharmacy_Operations/SitePages/Pharmaceutical-Compounding-and-Management-Standards.aspx https://dvagov.sharepoint.com/sites/VHAPBM/Pharmacy_Operations/SitePages/Pharmaceutical-Compounding-and-Management-Standards.aspx http://vaww.hefp.va.gov/resources/eps-sanitation-procedure-guide

o. VA Medical Facility Designated Compounding Pharmacist. A VA medical facility Designated Compounding Pharmacist assigned by the facility Chief of Pharmacy Service is responsible for:

(1) Collaborating with the VA medical facility Chief of Pharmacy Service to ensure a VA medical facility compounding contingency plan is in place that may be activated to obtain compounded preparations from alternative sources in situations where compounding services at the facility must be suspended.

(2) Collaborating with the VA medical facility Chief of Environmental Management Services, Chief of Engineering Service, Chief of Pharmacy Service and other relevant services to develop and implement a VA medical facility compounding contingency plan if primary compounding spaces are unable to be used.

(3) Collaborating with the VA medical facility Chief of Engineering Service to ensure engineering-related corrective actions associated with cleanroom environmental controls are completed and documented with records maintained based on VHA and USP requirements.

(4) Ensuring all outsourced compounded preparations meet the VHA procedural requirements for outsourcing compounded preparations. For more information on pharmaceutical compounding management standards, see https://dvagov.sharepoint.com/sites/VHAPBM/Pharmacy_Operations/SitePages/Pharmac eutical-Compounding-and-Management-Standards.aspx. NOTE: This is an internal VA website that is not available to the public.

(5) Ensuring the pharmacy service has written procedures for compliance with USP compounding standards, Federal law, VHA design requirements and the Joint Commission.

(6) Ensuring the training and competency of pharmacy personnel in accordance with USP compounding requirements and any facility SOPs related to compounding.

(7) Ensuring there is a process and an assigned individual who has training and documented competencies in place to review and interpret staff testing results related to Gloved Fingertip Tests(GFTs) and Media Fill Tests(MFTs). NOTE: Gloved Fingertip (GFT) and Media Fill Testing (MFT) VA clinical laboratories may interpret GFT and MFT samples if authorized by the VA medical facility Director or VISN Director and they meet all required elements for demonstration of quality and competency as defined in VHA National Laboratory guidance. However, advanced/specialized training (i.e., Pathologist/Microbiologist) is not required for staff to interpret the results of the GFT and MFT. The facility may designate an individual(s) for this responsibility (as an example, Industrial Hygienist (IH) staff may be considered to interpret GFTs and MFTs). For more guidance, see https://dvagov.sharepoint.com/:b:/r/sites/VHADiagnosticservices/PLMS/edcen/Document %20Library/Directive%20Guidance/Memos%20or%20Communications/Requirements%20 for%20VA%20Clinical%20Labs%20to%20Perform%20Pharmacy%20Quality%20Testing %2007-19-23-Final.pdf?csf=1&web=1&e=D5OQ46. This is an internal VA website that is not available to the public.

https://dvagov.sharepoint.com/sites/VHAPBM/Pharmacy_Operations/SitePages/Pharmaceutical-Compounding-and-Management-Standards.aspx https://dvagov.sharepoint.com/sites/VHAPBM/Pharmacy_Operations/SitePages/Pharmaceutical-Compounding-and-Management-Standards.aspx https://dvagov.sharepoint.com/:b:/r/sites/VHADiagnosticservices/PLMS/edcen/Document%20Library/Directive%20Guidance/Memos%20or%20Communications/Requirements%20for%20VA%20Clinical%20Labs%20to%20Perform%20Pharmacy%20Quality%20Testing%2007-19-23-Final.pdf?csf=1&web=1&e=D5OQ46 https://dvagov.sharepoint.com/:b:/r/sites/VHADiagnosticservices/PLMS/edcen/Document%20Library/Directive%20Guidance/Memos%20or%20Communications/Requirements%20for%20VA%20Clinical%20Labs%20to%20Perform%20Pharmacy%20Quality%20Testing%2007-19-23-Final.pdf?csf=1&web=1&e=D5OQ46 https://dvagov.sharepoint.com/:b:/r/sites/VHADiagnosticservices/PLMS/edcen/Document%20Library/Directive%20Guidance/Memos%20or%20Communications/Requirements%20for%20VA%20Clinical%20Labs%20to%20Perform%20Pharmacy%20Quality%20Testing%2007-19-23-Final.pdf?csf=1&web=1&e=D5OQ46 https://dvagov.sharepoint.com/:b:/r/sites/VHADiagnosticservices/PLMS/edcen/Document%20Library/Directive%20Guidance/Memos%20or%20Communications/Requirements%20for%20VA%20Clinical%20Labs%20to%20Perform%20Pharmacy%20Quality%20Testing%2007-19-23-Final.pdf?csf=1&web=1&e=D5OQ46

(8) Collaborating with the Chief of Environmental Management Services to develop a formal Memorandum of Understanding (MOU) for the delineation of duties related to the pharmacy compounding area’s cleaning and disinfecting protocol. Please refer to http://vaww.hefp.va.gov/resources/eps-sanitation-procedure-guide for MOU template.

NOTE: This is an internal VA website that is not available to the public.

(9) Collaborating with the Chief of Environmental Management Services to ensure competency documentation is available for any contracted cleaning services and to randomly observe the individuals performing these tasks.

(10) Collaborating with the Chief of Environmental Management Services to ensure training and competency assessment of specific elements for any staff personnel involved in cleaning the primary and secondary engineering controls, pursuant to USP <797>.

(11) Ensuring that pharmacy personnel complete appropriate cleaning documentation (including the cleaning products) used for pharmacy compounding rooms.

(12) Collaborating with the VA medical facility Chief of Engineering Services to ensure that PEC and SEC are certified in accordance with VHA procedural requirements, CETA CAG and USP compounding standards.

(13) Ensuring the VA medical facility Compounding Advisory Committee is provided all certification and environmental assessment reports and participating in reviews and corrective action plans.

(14) Collaborating with the VA medical facility Chief of Engineering Services to ensure appropriate selection and development of the statement of work for contracted certification and environmental testing services. Ensure there is no lapse in services for this critical requirement.

(15) Collaborating with the VA medical facility Chief of Engineering Service to ensure USP and VA design standards are incorporated in pharmacy compounding spaces including SCA’s and C-SCAs, cleanroom design, installation, renovation, or other construction projects.

(16) Collaborating with the VA medical facility Quality Manager, OS&H and Infection Prevention and Control to develop a formal written CSP Safety and Quality Assurance (QA) Plan to be established and implemented in accordance with VHA design requirements and USP compounding standards.

(17) Reviewing all certification and recertification records to ensure the compounding spaces meet the minimum USP standards and VA design requirements in addition to all required air quality standards in each classified area.

(18) Ensuring any personnel entering a compounding area observe all hygiene and garbing requirements and bring only necessary items or equipment related to their work to maintain the quality of the environment.

p. VA Medical Facility Nurse Executive. The VA medical facility Nurse Executive is responsible for:

(1) Specifying nursing staff requirements and competences for the preparation, handling, administration, and disposal of any compound preparations including hazardous drugs in accordance with VHA requirements, National Institute for Occupational Safety and Health (NIOSH), USP standards and any facility-approved HD AoR.

(2) Providing consultation and assistance to the VA medical facility Compounding Advisory Committee as needed.

q. VA Medical Facility Manager, Occupational Safety and Health Service. The VA medical facility Manager, Occupational Safety and Health Service is responsible for:

(1) Collaborating with the Designated Compounding Pharmacist or appropriate workplace supervisor(s) for alternative containment strategies, personal protective equipment and work practices.

(2) Ensuring personnel of reproductive capability who handle HDs confirm in writing that they understand the risks of handling HDs, pursuant to USP <800>.

r. VA Medical Facility Employee Occupational Health Service Manager. The VA medical facility Employee Occupational Health (EOH) Service Manager is responsible for:

(1) Enrolling employees who may be exposed to or handle HDs and requesting monitoring by the facility’s Medical Surveillance Program. Employees' enrollment and monitoring in the Medical Surveillance Program must be done in coordination with their supervisors and Occupational Safety and Health Services.

(2) Providing, in collaboration with the Occupational Safety and Health Service, occupational health and medical management advice and recommending interventional strategies for actual or potential exposures to HDs.

s. Chief, VA Medical Facility Engineering Service. NOTE: This position’s title may vary depending on the facility and may be delegated to service staff as appropriate (i.e., VA Medical Facility Chief Facilities Management Services, VA medical facility Chief Facilities Management Services or another facility-specific title). The VA medical facility Chief of Engineering Service is responsible for:

(1) Ensuring that USP and VA design standards are incorporated in pharmacy compounding spaces including SCA’s and C-SCAs, cleanroom design, installation, renovation, or other construction projects. NOTE: A pharmacy designee familiar with the requirements of USP should be involved in the design and construction process for pharmacy spaces; the facility advisory committees should review plans. VA medical facilities must comply with the VHA heating, ventilating and air-conditioning (HVAC) Design Manual (https://www.cfm.va.gov/til/dManual/dmHVAC.pdf), VA Technical Information Library (https://www.cfm.va.gov/til/) and the VHA Pharmacy Design Guide (https://www.cfm.va.gov/til/dGuide/dgPharm.pdf) when remodeling or constructing new cleanroom suites. These are internal VA websites that are not available to the public.

https://www.cfm.va.gov/til/dManual/dmHVAC.pdf https://www.cfm.va.gov/til/ https://www.cfm.va.gov/til/dGuide/dgPharm.pdf

(2) Ensuring that PECs and SECs are installed and maintained in compliance with USP compounding chapters and VA design standards including third party testing and certification. NOTE: VA uses the CETA CAGs to define certification procedures for assessing if the Primary and Secondary Engineering Controls are operating as designed to maintain a sterile environment for the preparation of CSPs.

(3) Ensuring all vendors conducting primary and secondary engineering control certifications:

(a) Employ at least one CETA National Board Testing (CNBT) Registered Certified Professional (RCP) for Sterile Compounding Facility (SCF) individual on staff who will review and sign the final certification report.

(b) Have required CETA competencies and training related to the certification of primary and secondary engineering controls. NOTE: it is preferred that the on-site certification individuals have received NSF accreditation for the field certification of Class II Biosafety Cabinets and are accredited through CNBT as a registered certification professional in the sterile compounding facility (RCP-SCF).

(4) Collaborating with the Designated Compounding Pharmacist to ensure engineering-related corrective actions associated with cleanroom environmental controls are completed.

(5) Collaborating with the VA medical facility Director, Designated Compounding Pharmacist, and Chief of Environmental Management Services to ensure the VA medical facility compounding contingency plan includes an assessment of an alternative site within the VA medical facility for the preparation of compounding, if compounding areas are unable to be used.

(6) Collaborating with the Pharmacy Service and Engineering Service in the design, selection and construction of all pharmacy compounding spaces including temporary systems and equipment selection.

(7) Submitting all pharmacy compounding space construction and renovation documents to the VHA Office of Healthcare Environmental and Facilities Programs (HEFP) Design Review Requests SharePoint site at 30%, 60% and 90% completion stages. The VA medical facility director is responsible for ensuring plans are submitted in a timely manner. The National HEFP Design Review Requests SharePoint can be found at https://dvagov.sharepoint.com/sites/VHA10NA5E/Pages/Design%20Review%20Requests .aspx#InplviewHash0d5612ed-3919-497f-a460-495aa09dab34=Paged%3DTRUE-p_VISN%3D19-p_Title%3D666%252dSheridan%2520VA%2520Medical%2520Center-p_ID%3D436-PageFirstRow%3D31#InplviewHashb7149a94-4b93-434b-9f9c-d1a798369b49=Paged%3DTRUE-p_VISN%3D22-p_Title%3D649%252dBob%2520Stump%2520VA%2520Medical%2520Center-p_ID%3D162-PageFirstRow%3D91-FilterFields1%3DVISN- FilterValues1%3D22%253B%252321%253B%252320%253B%252319-FilterOp1%3DIn.

NOTE: This is an internal VA website that is not available to the public.

https://dvagov.sharepoint.com/sites/VHA10NA5E/Pages/Design%20Review%20Requests.aspx#InplviewHash0d5612ed-3919-497f-a460-495aa09dab34=Paged%3DTRUE-p_VISN%3D19-p_Title%3D666%252dSheridan%2520VA%2520Medical%2520Center-p_ID%3D436-PageFirstRow%3D31#InplviewHashb7149a94-4b93-434b-9f9c-d1a798369b49=Paged%3DTRUE-p_VISN%3D22-p_Title%3D649%252dBob%2520Stump%2520VA%2520Medical%2520Center-p_ID%3D162-PageFirstRow%3D91-FilterFields1%3DVISN-FilterValues1%3D22%253B%252321%253B%252320%253B%252319-FilterOp1%3DIn https://dvagov.sharepoint.com/sites/VHA10NA5E/Pages/Design%20Review%20Requests.aspx#InplviewHash0d5612ed-3919-497f-a460-495aa09dab34=Paged%3DTRUE-p_VISN%3D19-p_Title%3D666%252dSheridan%2520VA%2520Medical%2520Center-p_ID%3D436-PageFirstRow%3D31#InplviewHashb7149a94-4b93-434b-9f9c-d1a798369b49=Paged%3DTRUE-p_VISN%3D22-p_Title%3D649%252dBob%2520Stump%2520VA%2520Medical%2520Center-p_ID%3D162-PageFirstRow%3D91-FilterFields1%3DVISN-FilterValues1%3D22%253B%252321%253B%252320%253B%252319-FilterOp1%3DIn https://dvagov.sharepoint.com/sites/VHA10NA5E/Pages/Design%20Review%20Requests.aspx#InplviewHash0d5612ed-3919-497f-a460-495aa09dab34=Paged%3DTRUE-p_VISN%3D19-p_Title%3D666%252dSheridan%2520VA%2520Medical%2520Center-p_ID%3D436-PageFirstRow%3D31#InplviewHashb7149a94-4b93-434b-9f9c-d1a798369b49=Paged%3DTRUE-p_VISN%3D22-p_Title%3D649%252dBob%2520Stump%2520VA%2520Medical%2520Center-p_ID%3D162-PageFirstRow%3D91-FilterFields1%3DVISN-FilterValues1%3D22%253B%252321%253B%252320%253B%252319-FilterOp1%3DIn https://dvagov.sharepoint.com/sites/VHA10NA5E/Pages/Design%20Review%20Requests.aspx#InplviewHash0d5612ed-3919-497f-a460-495aa09dab34=Paged%3DTRUE-p_VISN%3D19-p_Title%3D666%252dSheridan%2520VA%2520Medical%2520Center-p_ID%3D436-PageFirstRow%3D31#InplviewHashb7149a94-4b93-434b-9f9c-d1a798369b49=Paged%3DTRUE-p_VISN%3D22-p_Title%3D649%252dBob%2520Stump%2520VA%2520Medical%2520Center-p_ID%3D162-PageFirstRow%3D91-FilterFields1%3DVISN-FilterValues1%3D22%253B%252321%253B%252320%253B%252319-FilterOp1%3DIn https://dvagov.sharepoint.com/sites/VHA10NA5E/Pages/Design%20Review%20Requests.aspx#InplviewHash0d5612ed-3919-497f-a460-495aa09dab34=Paged%3DTRUE-p_VISN%3D19-p_Title%3D666%252dSheridan%2520VA%2520Medical%2520Center-p_ID%3D436-PageFirstRow%3D31#InplviewHashb7149a94-4b93-434b-9f9c-d1a798369b49=Paged%3DTRUE-p_VISN%3D22-p_Title%3D649%252dBob%2520Stump%2520VA%2520Medical%2520Center-p_ID%3D162-PageFirstRow%3D91-FilterFields1%3DVISN-FilterValues1%3D22%253B%252321%253B%252320%253B%252319-FilterOp1%3DIn https://dvagov.sharepoint.com/sites/VHA10NA5E/Pages/Design%20Review%20Requests.aspx#InplviewHash0d5612ed-3919-497f-a460-495aa09dab34=Paged%3DTRUE-p_VISN%3D19-p_Title%3D666%252dSheridan%2520VA%2520Medical%2520Center-p_ID%3D436-PageFirstRow%3D31#InplviewHashb7149a94-4b93-434b-9f9c-d1a798369b49=Paged%3DTRUE-p_VISN%3D22-p_Title%3D649%252dBob%2520Stump%2520VA%2520Medical%2520Center-p_ID%3D162-PageFirstRow%3D91-FilterFields1%3DVISN-FilterValues1%3D22%253B%252321%253B%252320%253B%252319-FilterOp1%3DIn https://dvagov.sharepoint.com/sites/VHA10NA5E/Pages/Design%20Review%20Requests.aspx#InplviewHash0d5612ed-3919-497f-a460-495aa09dab34=Paged%3DTRUE-p_VISN%3D19-p_Title%3D666%252dSheridan%2520VA%2520Medical%2520Center-p_ID%3D436-PageFirstRow%3D31#InplviewHashb7149a94-4b93-434b-9f9c-d1a798369b49=Paged%3DTRUE-p_VISN%3D22-p_Title%3D649%252dBob%2520Stump%2520VA%2520Medical%2520Center-p_ID%3D162-PageFirstRow%3D91-FilterFields1%3DVISN-FilterValues1%3D22%253B%252321%253B%252320%253B%252319-FilterOp1%3DIn https://dvagov.sharepoint.com/sites/VHA10NA5E/Pages/Design%20Review%20Requests.aspx#InplviewHash0d5612ed-3919-497f-a460-495aa09dab34=Paged%3DTRUE-p_VISN%3D19-p_Title%3D666%252dSheridan%2520VA%2520Medical%2520Center-p_ID%3D436-PageFirstRow%3D31#InplviewHashb7149a94-4b93-434b-9f9c-d1a798369b49=Paged%3DTRUE-p_VISN%3D22-p_Title%3D649%252dBob%2520Stump%2520VA%2520Medical%2520Center-p_ID%3D162-PageFirstRow%3D91-FilterFields1%3DVISN-FilterValues1%3D22%253B%252321%253B%252320%253B%252319-FilterOp1%3DIn

(8) Ensure that the Engineering Service reviews and responds to comments from the National Compounding Advisory Committee about construction and design of pharmacy compounding spaces.

t. Chief, VA Medical Facility Environmental Management Services. The Chief of VA medical facility Environmental Management Services (EMS) is responsible for:

(2) Collaborating with the Chief of Pharmacy Service through formal Memorandum of Understanding (MOU) or departmental SOPs to establish the delineation of duties related to the pharmacy compounding area’s cleaning and disinfecting protocol. Please refer to http://vaww.hefp.va.gov/resources/eps-sanitation-procedure-guide for MOU template.

NOTE: This is an internal VA website that is not available to the public.

(3) Collaborating with the Chief of Pharmacy Service to review and approve non-VA contracted cleaning services for pharmacy compounding spaces. Obtaining documentation of competency training and assessment of staff conducting the cleaning from the contracted services vendor.

(4) Working with the Designated Compounding Pharmacist to oversee and randomly observe the staff conducting cleaning services in compounding areas.

(5) Ensuring pharmacy compounding areas are cleaned pursuant to VHA requirements and USP standards; standard operating procedures (SOPs) are implemented and communicated to any staff personnel involved with cleaning the spaces; compliance is consistent and continuously monitored and documentation is maintained. Please refer to http://vaww.hefp.va.gov/resources/eps-sanitation-procedure-guide for standardized SOP and processes. NOTE: This is an internal VA website that is not available to the public.

(5) Collaborating with the Chief of Pharmacy Service to ensure that personnel responsible for cleaning compounding spaces have proper training and documented annual competencies for cleaning and disinfection of the pharmacy compounding spaces.

Please refer to http://vaww.hefp.va.gov/resources/eps-sanitation-procedure-guide for EMS competency information. NOTE: This is an internal VA website that is not available to the public.

(6) Ensuring that EMS personnel complete appropriate cleaning documentation indicating the cleaning products used and tasks performed for pharmacy compounding rooms.

(7) Collaborate with the Chief of Pharmacy Service to ensure all cleaning, sanitizing, decontaminating and rinsing agents used to clean pharmacy compounding areas and equipment have been evaluated, are on the VHA Medical Surgical Prime Vendor (MSPV) product list and are approved for utilization within the VHA.

(8) Ensuring that EMS has a contingency plan to provide alternative cleaning personnel that have been appropriately trained and have signed competencies in cases where regularly scheduled personnel are not available.

3. STERILE COMPOUNDING

http://vaww.hefp.va.gov/resources/eps-sanitation-procedure-guide https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fvaww.hefp.va.gov%2Fresources%2Feps-sanitation-procedure-guide&data=04%7C01%7C%7C9700318f1af046d36c3108d9e2a2b1ea%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637790010653999596%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=XuLipS0y1q7sixOOebN8GvTV9jPPlUCv6vCyHq%2B6vxY%3D&reserved=0

a. VA pharmacies are required to use commercially available sterile admixtures and drug products or, when unavailable, commercially available therapeutic alternative drug products. VA medical facilities will not prepare compounded sterile products from any non-sterile components that require sterility performing and testing procedures. If commercially prepared products are unavailable, VA medical facility pharmacies must compound or may outsource sterile drug preparations as needed in accordance with this directive.

b. VA pharmacies must ensure that all compounded sterile preparations (CSPs) are accurately identified, measured, diluted, mixed, prepared, packaged, sealed, labeled, stored, dispensed, procured, and distributed in accordance with:

(1) United States Pharmacopeia (USP) Compounding standards

(2) VHA Pharmacy Benefits Management (PBM) Guidance and Procedural Requirements for CSPs which can be found at https://dvagov.sharepoint.com/sites/VHAPBM/Pharmacy_Operations/VHA PBM Compounding Guidance Documents/Forms/AllItems.aspx?viewid=6a64c982%2Dc912%2D4cba%2D89a1%2Dab9 76a7e8851&id=%2Fsites%2FVHAPBM%2FPharmacy%5FOperations%2FVHA%20PBM %20Compounding%20Guidance%20Documents%2FVHA%20PBM%20CSP%20GUIDAN CE%20DOCUMENTS. NOTE: This is an internal VA website that is not available to the public.

c. All hazardous (e.g., cancer chemotherapy) CSPs must be prepared in an appropriate area separated from routine non-hazardous sterile product preparations. They must be prepared in a manner compliant with USP <800> standards and NIOSH requirements.

d. All antineoplastic hazardous drugs requiring further manipulation must be stored separately from other inventory in a manner to prevent contamination and personnel exposure that conform with USP <800> standards. NOTE: Antineoplastic drugs only refer to those included in the most current Table 1 NIOSH list and any deemed as similar per facility review.

e. CSPs may be prepared in limited anticipatory quantities before receipt of a medication order and labeled in accordance with USP <797>. Medications orders may be in the form of chart orders, inpatient or outpatient orders.

f. A pharmacist must inspect outsourced CSPs for quality prior to dispensing or administration within the medical facility.

g. CSPs compounded by the pharmacy after receipt of a medication order must have a label placed directly to the compounded preparation and delivered to the patient care area.

(1) These labels must comply with USP <797> and contain [at a minimum] the following:

(a) The patient’s name (excludes those CSPs prepared for anticipatory compounding https://dvagov.sharepoint.com/sites/VHAPBM/Pharmacy_Operations/VHA%20PBM%20Compounding%20Guidance%20Documents/Forms/AllItems.aspx?viewid=6a64c982%2Dc912%2D4cba%2D89a1%2Dab976a7e8851&id=%2Fsites%2FVHAPBM%2FPharmacy%5FOperations%2FVHA%20PBM%20Compounding%20Guidance%20Documents%2FVHA%20PBM%20CSP%20GUIDANCE%20DOCUMENTS…