Off-Site Pharmacy Compounding Considerations

Health Dimensions is:

• Compliant with or exceeding applicable state board of pharmacy rules and regulations
• Compliant with or exceeding applicable ASHP and USP guidelines and standards
• Compliant with or exceeding applicable DEA regulations
• Compliant with or exceeding applicable State, Federal, and municipal laws

Health Dimensions can:

• 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.
• Describe the method(s) used to validate the sterility of sterile products compounded, the documentation format, and the time period the documentation is maintained.
• Describe the method(s) used for pyrogen testing, the documentation format, and the time period the documentation is maintained.
• Provide a listing of references available to pharmacists and pharmacy technicians involved with the compounding process.
• 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.
• 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.
• Describe the methodology(ies) used to establish beyond-use dating for compounded products.
• Describe procedures used to ensure delivery of sterile products during natural disasters, drivers’ strikes, or other potentially disruptive events.

Health Dimensions is able to:

• Ensure that the labeling of the compounded product is in accordance with State and Federal laws.
• Provide documentation of end-product testing indicating that compounded sterile products are sterile and pyrogren-free.
• 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.
• Deliver all compounded products in tamper-resistant packaging and in containers that will maintain proper storage temperature during the delivery process.

Health Dimensions can offer contracting agreements that:

• 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.
• Contain a confidentiality clause and a HIPAA business associate agreement.
• Establish the pharmacy’s right to inspect the premises of the compounding facility at any time, including the right to inspect quality control reports.
• Describe the method of communicating the medication order/prescription from the medical center pharmacy to the compounding pharmacy.
• 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).
• Protect the contracting pharmacy from liabilities created by errors made by the compounding pharmacy.
• Establish product recall procedures (to the patient level) should a product need to be recalled by the compounding pharmacy.
• Address the documentation, regulatory and/or accreditation compliance, compounding process, and compounded product considerations described in Sections II-V above.