Department of Pharmacy Policies & Procedures

Number: 4:09

Effective Date: March 2008

Revisions:

Reviewed: 7/09

Approval: 3/08

Subject: OUTSIDE COMPOUNDING PHARMACY AGREEMENT

A. PURPOSE

To set forth guidelines when using an outside pharmacy to compound drugs for UAMS.

B. POLICY

Compounded products may be obtained from an off-site compounding pharmacy for the following reasons: (1) the compounded product can be prepared more efficiently and economically by a compounding pharmacy; or (2) there is not an appropriate product available from a pharmaceutical manufacturer due to manufacturing problems, a shortage of raw materials, or a pharmaceutical company’s decision to stop manufacturing the product.

C. PROCEDURE

1. The UAMS Pharmacy Department will approve outside vendors based on their CSP quality. The attached form will be used to assess their quality systems and USP <797> compliance.

2. All outside vendors used for compounding will be required to submit to an on-site audit of their compounding operations if requested by the UAMS Pharmacy Director.

3. Vendor qualifications will be reviewed by the UAMS Pharmacy Director.

4. If a vendor does not meet qualifications, a date by which all deficiencies must be corrected will be given. A required response date will be communicated. Failure of the vendor to comply will result in non-approval of the vendor to perform compounding activities.

5. If no deficiencies are found or when the cited deficiency(s) are corrected to the satisfaction of the UAMS Pharmacy Department, then the vendor will be placed on the UAMS Approved Compounding Vendor List.

6. If there is a problem with a vendor within the 1 year window, a new audit will be initiated.

Compounding Vendor Survey Form Date:___________

Vendor/Company Name: ____________________________________________

Street: __________________________________________________________

City: ______________________ State: ____ Zip Code: ________________

Telephone: _____________________ Fax: ______________________

Notice: I (we) certify that the information contained in this survey form is accurate and complete as of the date indicated. All information obtained will be kept confidential. This survey has been completed with the permission of the company surveyed.

Signature Title

Signature Title

________________________________________________________________

Part I: GENERAL INFORMATION

Years in Business: ___________

Privately Owned: YES NO

Subsidiary Division of: __________________________________________

Other Plant Locations: __________________________________________

List Major Customers: Type of CSP:

__________________________________ _____________________

__________________________________ _____________________

__________________________________ _____________________

List Company Management:

Name: Title:

__________________________________ _____________________

__________________________________ _____________________

__________________________________ _____________________

Service to be performed for UAMS: ____________________________________

Hours of Operation: ________________ Days per week: ______________

Are training program for personnel utilized? YES NO

Topics of Training Programs: _________________________________________

________________________________________________________________

________________________________________________________________

Proficiency Based? YES NO

Certifications Provided? YES NO

Recertification Period: ______________________________________________

Describe Training Program: __________________________________________

________________________________________________________________

________________________________________________________________

Part II: FACILITY

Has your facility been inspected by any state or federal agencies within the last two years? YES NO

Name(s) of Agencies: Date:

_________________________________ _____________

_________________________________ _____________

_________________________________ _____________

Do you have liability insurance? YES NO

Are written compounding procedures (SOPs) in place (provide copies when requested)? YES NO

How often are procedures reviewed? ____________________________

Are calibration records kept on file? YES NO

Are calibration standards traceable? YES NO

Part III: QUALITY CONTROL/ASSURANCE

Are the Quality procedures in a formal written document? YES NO

Are the procedures revised/reviewed on a periodic basis? YES NO

Is the facility registered or licensed by a federal, state, or

professional agency? YES NO

Which ones? __________________________________

__________________________________

__________________________________

Is there a formal quality assurance program involving

Performance testing of equipment used for testing? YES NO

Environmental Monitoring performed? YES NO

Surfaces YES NO

Air YES NO

Personnel YES NO

Particle counts YES NO

Cleanroom Certification YES NO

CSP Testing USP <71> Sterility YES NO

CSP Testing USP <85> Endotoxin YES NO

USP <797> Compliance program YES NO