by James Rinehart, M.S., FASHP and Sue Heckman, Pharm.D.

Below are some questions to be asked when considering contracting with an off-site compounding pharmacy. These questions were developed through the authors' experience and conversations with their colleagues from across the U.S. and may not be directly applicable to all practice settings. Please send suggestions or additional considerations to ASHP at quality@ashp.org.

I. Questions regarding characteristics of the off-site compounding pharmacy

1. When did the pharmacy begin offering sterile compounding services?
2. What are the pharmacy's regular business hours and/or hours of operation?
3. What methods are available to contact the pharmacy at times other than regular business hours?
4. What healthcare organizations and/or pharmacies have been served by the pharmacy, and what types of sterile compounded products have been provided?
5. Has the pharmacy had product liability claims filed against it for products compounded by the pharmacy?
• If the pharmacy has had any product liability claims filed against it, will the pharmacy provide a description of the claim(s) filed, the file date of the claim(s), and the outcome of the review of the claim(s) filed?
6. Has the pharmacy ever recalled any of its compounded products?
• If the pharmacy has ever recalled any of its compounded products, will they provide the date(s) of recall, a description of the product(s) recalled, and the reason(s) for the recall?

II. Required documentation

Will the off-site compounding pharmacy be able to provide the following documents:

1. Proof of current liability insurance.
2. Current accreditation or certification certificates.
3. State pharmacy licensure.
4. Licensure of pharmacists employed.
5. Pharmacy technician notarized statements stating they have never been convicted of a drug-related misdemeanor for felony.
6. Licensure documents if the pharmacy is licensed by the FDA for pharmaceutical manufacturing.
7. Current DEA registration.
8. Standard operating procedures manual.
9. Pharmacist training manual.
10. Pharmacy technician training manual.
11. Policies and procedures for sterility testing.
12. Policies and procedures for pyrogen testing
13. Examples of the quality control reports

III. Questions regarding regulatory/accreditation compliance

Is the pharmacy:

1. Compliant with or exceeding applicable state board of pharmacy rules and regulations?
2. Compliant with or exceeding applicable ASHP and USP guidelines and standards?
3. Compliant with or exceeding applicable CMS and JCAHO regulations, rules, and standards?
4. Compliant with or exceeding applicable DEA regulations?
5. Compliant with or exceeding applicable State, Federal, and municipal laws?

IV. Questions regarding the offsite pharmacy's compounding processes

1. Provide evidence that the pharmacy ensures that all members of its compounding staff are qualified to produce compounded products, including:
   
   • A listing of the competencies required of staff involved in the compounding process, the frequency of reassessment of the competencies of staff members, and the methods used to document successful completion of the competencies.
   • Evidence that each individual involved with the compounding process has demonstrated competency for their specific work assignment.
2. Describe the method(s) used to validate the sterility of sterile products compounded, the documentation format, and the time period the documentation is maintained.
3. Describe the method(s) used for pyrogen testing, the documentation format, and the time period the documentation is maintained.
4. Provide a listing of references available to pharmacists and pharmacy technicians involved with the compounding process.
5. Demonstrate that USP/NF grade products are used to prepare sterile products.
• If the pharmacy uses products that are not USP/NF grade in the preparation of sterile products, will they be able to provide a list of the non-USP/NF products used, the grade of the products used, and the reason the USP/NF product is not used.
• If a non-USP/NF ingredient is used in the compounding process, will the compounding pharmacy provide a certificate of analysis and potency testing of the bulk ingredient at the time of dispensing.
6. Demonstrate that the pharmacy is classified as a USP 797 high-risk (level 3) compounding facility, and provide evidence through documentation that all processes and testing for this classification are followed.
7. Describe the methodology(ies) used to establish beyond-use dating for compounded products.
8. Describe procedures used to ensure delivery of sterile products during natural disasters, drivers' strikes, or other potentially disruptive events.

V. Questions regarding compounded products

1. Ensure that the labeling of the compounded product is in accordance with State and Federal laws.
2. Provide documentation of end-product testing indicating that compounded sterile products are sterile and pyrogren-free.
3. Guarantee that each compounded product will be accompanied by a certificate that attests that the product is sterile, according to professionally established and accepted quality monitoring data.
4. Deliver all compounded products in tamper-resistant packaging and in containers that will maintain proper storage temperature during the delivery process.

VI. Questions regarding the compounding pharmacy agreement

1. Describe the term length of the agreement and the processes for compounding pharmacy billing to the contracting pharmacy, including methods of determining the charge for the compounded items, payment terms, and processes for resolution of disputed invoices?
2. Contain a confidentiality clause and a HIPAA business associate agreement?
3. Establish the pharmacy's right to inspect the premises of the compounding facility at any time, including the right to inspect quality control reports?
4. Describe the method of communicating the medication order/prescription from the medical center pharmacy to the compounding pharmacy.
5. Delineate routine compounding turn-around times (e.g., from receipt of the medication order/prescription by the compounding pharmacy to delivery to the contracting pharmacy) and describe acceptable deviations from the agreed-upon schedules (e.g., raw product availability problems, unique end-product testing requirements, compounded product stability characteristics).
6. Protect the contracting pharmacy from liabilities created by errors made by the compounding pharmacy.
7. Establish product recall procedures (to the patient level) should a product need to be recalled by the compounding pharmacy.
8. Address the documentation, regulatory and/or accreditation compliance, compounding process, and compounded product considerations described in Sections II-V above.
   

VII. Questions regarding the contracting (medical center) pharmacy's processes

1. Has the proper body of the contracting pharmacy (e.g., the institution's Pharmacy and Therapeutics Committee) developed a formal process to identify which products will (and which products will not) be prepared by the compounding pharmacy, based on the therapeutic needs of patients and inherent risks associated with using a compounding pharmacy?
2. Has the contracting pharmacy established the components of the medication order/prescription?
3. Has the contracting pharmacy determined whether patient consent must be obtained for use of products compounded at pharmacies other than the contracting pharmacy?
4. Has the agreement and/or the compounding pharmacy facility been reviewed by all the necessary bodies in the contracting pharmacy's organization, including the organization's risk management team, legal counsel, Pharmacy and Therapeutics and Infection Control committees, and epidemiology department staff?
5. Has the contracting pharmacy determined how to handle situations in which a patient presents with a compounded medication that the contracting pharmacy does not compound (e.g., medication in an implantable device, IV push medication, or IV infusion) and that has not been previously considered by the Pharmacy and Therapeutics Committee?
• What will the process be for the Pharmacy and Therapeutics Committee to consider having such medications prepared by the compounding pharmacy?
• Until the Pharmacy and Therapeutics Committee decision is obtained regarding such medications, how are the following to be handled?
• How will the interim supply of the patient's own medication be administered within the contracting pharmacy's institution, and what are the associated liability risks?
• What will the process be for acquiring such medications from a compounding pharmacy that the contracting pharmacy's institution does not have an agreement with, and what are the associated liability risks?
• If the contracting pharmacy's institution agrees to have the product prepared by the compounding pharmacy they have an agreement with, and the compounding pharmacy cannot prepare the product, how are the following issues to be handled?
• How will the interim supply of the patient's own medication be administered within the contracting pharmacy's institution, and what are the associated liability risks?
• What will the process be for continuing to acquire such medications if the compounding pharmacy already under contract will not prepare them, and what are the associated liability risks (e.g., will the contracting pharmacy negotiate an agreement with the pharmacy that does compound the product).

 

James Rinehart earned his Bachelor of Science in Pharmacy degree from the University of Wisconsin – Madison. He was a clinical pharmacist at University of Wisconsin Hospital and Clinics. He then went on to complete a Master of Science in Pharmacy degree from the University of Wisconsin - Madison, and a two-year pharmacy practice residency with an administrative emphasis at the University of Wisconsin Hospital and Clinics. Since 1991, Jim has been the Director of Pharmacy at BryanLGH Medical Center, where he is responsible for the management of the operational, clinical, retail, and financial services of the pharmacy department. In this role, he is responsible for approximately 650 licensed beds on two hospital campuses, a retail pharmacy and medical clinics, along with managing affiliated pharmacy school academic programs. He is responsible for 76 FTEs in the pharmacy department, both inpatient and outpatient, including a retail pharmacy.

Sue Heckman earned her Doctor of Pharmacy degree from the University of Nebraska. She is Pharmacy Sterile Products Manager at BryanLGH Medical Center.

 

All opinions expressed in this document are those of the authors. When evaluating specific recommendations regarding compounding practices, practitioners are strongly encouraged to rely on a wide array of sources, including state and local authorities, accrediting bodies such as the Joint Commission on Accreditation of Healthcare Organizations, and organizations such as ASHP and the United States Pharmacopeia, as well as fellow practitioners such as the authors.