26-73021-000_RFI_for_Compounding_Pharmacy_Services_.pdf

REQUEST FOR INFORMATION

RFI Number: 26-73021-000

Compounding Pharmacy Services

Release Date: September 11, 2026

Response Due: September 30, 2026

You are invited to review and respond to this Department of State Hospitals (DSH) Request for Information (RFI).

The DSH is seeking to better understand the marketplace and potential bidder pool for one or more contractors to provide intramuscular (IM) compound clozapine to support patient care across DSH's statewide hospital system.

The DSH is seeking the input of qualified vendors to better understand the types of capabilities they provide and how they structure their costs.

The DSH is seeking to establish a bidder pool for a future solicitation.

For more information, please review the Description of Services and RFI Requirements included below.

Please note that this RFI is not a solicitation for services.

Department of State Hospitals

TABLE OF CONTENTS

DISCLAIMER

A. PURPOSE

B. BACKGROUND

C. DESCRIPTION OF SERVICES

1. Summary Of Work To Be Performed

2. Contractor Responsibilities

D. MINIMUM QUALIFICATIONS

E. CONTENT OF SUBMISSION

F. RESPONDENT QUESTIONS

G. KEY ACTION DATES

H. DEPARTMENTAL CONTACT

DISCLAIMER – PLEASE READ BEFORE RESPONDING TO THIS RFI

1. DSH will not reimburse Respondents for any costs associated with their responses to this

RFI.

2. DSH has no obligation to buy or issue a solicitation to any Respondent as a result of this

RFI.

3. Information provided in response to this RFI will not be considered when evaluating bidders responding to any future procurement.

4. Participants are advised that the responses to this RFI are subject to the Public Records Act.

5. Information provided in response to this RFI related to any costing should be estimated costs, only to be used by DSH for informational and planning purposes and understood not to be represented as a bid from the Respondent.

6. DSH, at its sole discretion, may invite Respondents to this RFI to make a presentation or engage in a confidential conversation concerning their response.

7. DSH may, at its sole discretion, may choose to not consider or evaluate any response, or any portion of a response, received as a result of this RFI.

A. PURPOSE

1. The purpose of this Request for Information (RFI) is to engage with interested parties to provide the Department of State Hospitals (DSH) to conduct market research and identify licensed compounding pharmacies capable of providing intramuscular (IM) compound clozapine to support patient care across DSH's statewide hospital system.

2. A scope of work describes the services being sought. The information received from this RFI may be utilized in a scope of work for use in a future solicitation.

3. This request is issued solely to obtain information to consider for a solicitation and does not constitute a competitive solicitation.

B. BACKGROUND

1. The Department of State Hospitals (DSH) manages the nation’s largest inpatient forensic mental health hospital system. Its mission is to provide evaluation and treatment in a safe and responsible manner, seeking innovation and excellence in state hospital operations, across a continuum of care and settings. DSH is responsible for the daily care and provision of mental health treatment of its patients. DSH oversees five state hospitals located at Atascadero, Coalinga, Metropolitan – Los Angeles, Napa and Patton.

DSH Serves individuals under judicial commitment (penal and civil commitments) who require inpatient psychiatric treatment. A subset of the patient population is clinically indicated for injectable antipsychotic therapies, including IM compound clozapine, where oral administration is clinically contraindicated, refused, or otherwise not viable.

Reliable access to qualified compounding pharmacy services capable of preparing and delivering IM compound clozapine and related specialty formulations is critical to continuity of psychiatric care, patient safety, and regulatory compliance across all five facilities.

2. DSH is considering a competitive solicitation for a licensed compounding pharmacy

(Contractor) and seeks information from contractors who may be interested in providing those services.

C. DESCRIPTION OF SERVICES

1. Summary Of Work to Be Performed. The following provides information on the services DSH is seeking information from compounding pharmacies and estimated costs.

A. Provide sterile compounding services for Intramuscular (IM) compound clozapine, ensuring all standards for safety and efficacy.

B. Maintain and provide documentation of all necessary state licenses, including Licensed Sterile Compounding or Class E-S (Non-Resident Sterile Compounding) licensure, and demonstrate full compliance with USP <795>/<797>/<800> standards.

C. Establish and maintain a secure, temperature-controlled, and reliable distribution chain capable of delivering compounded medications to all five DSH state hospital locations (Atascadero, Coalinga, Metropolitan, -Los Angeles, Napa, and Patton).

D. Implement a robust quality management program that includes routine environmental monitoring, potency testing, and batch sterility assurance to ensure patient safety across the DSH system.

E. Provide transparency in the compounding process, including the ability to supply batch records, certificates of analysis, and clear communication regarding supply chain status and lead times.

F. Assist DSH in developing efficient ordering and delivery protocols to ensure continuity of care for patients where oral administration is clinically contradicted, refused, or otherwise not viable.

G. Participate in consultative discussions with DSH clinical and pharmacy leadership to align compounding pharmacy services with evolving patient needs and hospital formulary requirements.

H. Optional preferred service: provide expedited or “emergency” compounding delivery services for urgent clinical situations where immediate access to IM compound clozapine is required for patient stabilization.

2. Contractor Responsibilities

A. Maintain all required pharmacy licensure, including LSC or Class E-s designations, in good standing with the State Board of Pharmacy and all relevant regulatory bodies. The contractor must ensure all compounding activates strictly adhere to USP 797 and 800 standards.

B. Implement and maintain a comprehensive quality management system. This includes, but is not limited to, routine environmental monitoring, end-product potency testing, sterility assurance, and rigorous documentation of all compounding processes.

C. Ensure the secure, temperature controlled, and timely delivery of compounded medications to all five state hospital locations. The contractor is responsible for maintaining the cold chain and product integrity from the point of compounding through final delivery at the designated hospital site.

D. Provide comprehensive documentation for every batch, including Certificates of Analysis (COA) and batch production records. The contractor must maintain clear, accessible records for all orders to support DSH’s internal auditing and regulatory compliance needs.

E. Maintain a dedicated point of contact for DSH pharmacy leadership to address clinical questions, order status inquiries, and supply chain updates. The Contractor shall promptly notify DSH of any potential supply disruptions or changes in compounding capacity.

D. MINIMUM QUALIFICATIONS

1. The following minimum qualifications give you an idea of the contractors DSH is seeking information from and the nature of the services for which information is sought. These minimum qualifications will be similar or identical to those that will be in the final solicitation.

The contractor is not required to meet these minimum qualifications at the time of the RFI proposal submission.

A. Contractor will be required to have a legal right to do business in the State of California. Contractor will meet all terms and conditions for operating a business in the city/county in which the business is headquartered.

B. Contractor will be required to have a license to do business Contractor, at its own expense, will be required to maintain and possess such license, and any and all necessary license(s), permit(s), and certificate(s) required by California law.

C. Contractor must demonstrate full compliance with all applicable USP standards, specifically USP <795>/<797>/<800>, for the sterile compounding or injectable psychiatric medications.

D. Contractor must provide reasonable access to quality assurance documentation and batch related data as requested by DSH. Such information will be handled in accordance with California state law and DSH privacy requirements.

E. Contractor must be able to provide adequate staffing, with flexibility, and should specify if services detailed in the Description of Services section above can be provided.

F. Optional preferred service: Contractor should specify if they have access to clinical experts, such as a board-certified psychiatric pharmacist or psychiatrist, to consult on complex compounding formulations and clinical applications.

E. CONTENT OF SUBMISSION

1. Respondents to this RFI are asked to submit a written response that articulates their experience in accordance with the following guidelines:

A. Current pharmacy licensure status, specifically confirming active LSC or Class E-S

(Non-Resident Sterile Compounding) designation.

B. Whether the pharmacy has adequate staff with the requisite expertise and experience to provide sterile compounding of psychiatric pharmacotherapies for a statewide hospital system.

C. Describe their experience in working with other forensic psychiatric facilities or large-scale healthcare systems, if any.

D. Describe experience working in collaboration with other entities and complying with terms and conditions established for a client.

E. Submit cost estimates for services offered.

2. If Respondents are interested in participating in this RFI, please complete and submit a written response and the RFI Cover Sheet (Attachment 1) as follows:

a. RFI Cover Sheet (Attachment 1)

b. Written Response describing:

i. The Respondent’s primary business focus, areas of expertise, certifications and/or credentials relevant to the content of this RFI, and years of experience with similar services;

ii. The Respondent’s experience doing business with the State of California; and,

iii. Recommendations based on the information requested in the Minimum

Qualifications (Section D) and this section E

iv. Estimated costs of services

c. Any additional information that the Respondent might find relevant to the RFI

3. Submit one (1) electronic copy of the response to the contact person named in section H below by email. Include the following information in the subject line of the email: RFI 26- 73021-000 Compounding Pharmacy Services.

4. Submit RFI by the deadline identified in the Key Action Dates in section G, below.

F. RESPONDENT QUESTIONS

1. Submit questions regarding this RFI via e-mail by the specified date identified in the Key Action Dates to the contract person listed in the Departmental Contact, in section H, below.

2. Include the following in the email inquiry:

a. Subject line: RFI #26-73021-000 Compounding Pharmacy Services

b. Respondent name, contract person, telephone number, and email address

c. A description of the subject or issue in question, or discrepancy found in the RFI

d. The RFI section, page number, and/or other information useful in identifying the specific problem or issue in question

e. The Respondent’s question(s)

3. DSH may contact Respondents to seek clarification of any inquiry received. The DSH may respond to questions directly to the Respondent or release an addendum or updated RFI.

G. KEY ACTION DATES

Event Date Time

RFI Posted / Sent to Potential Respondents September 10, 2026 8:00 AM

RFI Questions Due September 16, 2026 3:00 PM

Q&A Response Anticipated September 23, 2026 3:00 PM

RFI Responses Due September 30, 2026 3:00 PM

RFI Follow-Up Conducted, If Applicable October 5, 2026 3:00 PM

H. DEPARTMENTAL CONTACT

All correspondence related to this RFI shall be directed to:

Attention: Jessica Schwartz Email: Jessica.Schwartz@dsh.ca.gov and SACContracts@dsh.ca.gov

ATTACHMENT 1

RFI Cover Sheet

Respondent Name (Name and Title):

Address:

Telephone Number:

Email:

Small Business or Disabled Veteran Business Enterprise?

Are you a State of California Certified Small Business (SB) or Disabled Veteran Business Enterprise (DVBE)?

Yes___ No____

If yes, please provide your SB/DVBE certification number: ______________________

Respondent’s Primary RFI Contact (Name, Title, Phone Number and E-mail):

Respondent’s Signature: