Compounding pharmacies are pharmacies that create personalized medications by mixing ingredients based on a doctor’s prescription in an effort to meet a person’s needs. Though compounding pharmacies lost popularity in the 50s and 60s when mass drug manufacturing began, it has recently been gaining in popularity as many mass-produced drugs don’t meet patient’s needs. Compounding pharmacies allow pharmacists to personalize the strength, flavor, ingredients, and form of a drug product.
While the FDA is responsible for the safety and regulation of drug products through drug manufacturers, individual states regulate pharmacies, including compounding pharmacies, the FDA regulates the ingredients they use, and the Drug Enforcement Administration regulates how compounding pharmacies handle controlled substances.
Compounding pharmacies, along with other settings in which compounded sterile preparations are prepared, are subject to the guidelines outlined in USP 797, “Pharmaceutical Compounding – Sterile Preparations,” which details the sterile compounding standards, guidelines, procedures, and compliance requirements enforced and set forth by the US Pharmacopeia for compounding sterile preparations. Compliance with USP 797 requires that the level of risk associated with the compounding facility be determined, a practice gap analysis of compounding activities, and an action plan for compliance be developed.
Need help from a laboratory with testing or analysis for USP 797 compliance? Let us help! Call us at 1-855-377-6821, or submit a test request on our website.
USP 797 Test Requests Contract Laboratory has Helped Facilitate:
- A chain of hospital pharmacies needs microbiology and pharmaceutical laboratories for USP testing to comply with USP 797. Facilities conducting glove tip sampling and surface sampling using contact plates (2 growth media for fungal and bacteria). I am searching for a company that can provide incubation for our contact plates and then identify to genus level for any positive growth in our samples. As to anticipated volume: 1. Glove Tip samples – We have approximately 150 pharmacy technicians that would require glove tip sampling (annually = 2 bacteria contact plates and 2 fungal contact plates) = ~600 plates/year 2. Surface sampling – Each of the 16 facilities will test ~8 locations within the IV room per month = ~1536 surface contact plates/year Total plates to incubate = 2136 with an estimated 30% positive results = 641/year testing to genus level Could you please provide a quote on the services that your company can provide and then any additional information that you feel may be helpful for me to know (i.e. related to the shipment of plates to your company, reporting capabilities, QA process, CETA certification
- Rhode Island Pharmaceutical laboratory needed for USP Testing. GC-MS, VOLTAMMETRY, LC/MS/MS, HPLC, HPLC/ESI-MS/MS, HPLC/MS/MS. Complying with USP 797 standards, need testing for hazardous drugs testing on surfaces and areas adjacent to hazardous drug (chemo) preparation
- FDA GMP laboratory needed for environmental monitoring testing as per recent USP <797> Guidelines for environmental particulate count monitoring needs assessment of current product line packaging Guidelines Dynamic environment testing All identified products/packaging configurations will be tested in four pharmacy environments under routine conditions of use by a qualified pharmacist or technician. The four environments will be: Unclassified pharmacy staging area; ISO Class 8 anteroom; ISO Class 7 cleanroom and ISO Class 5 engineering control (laminar airflow workbench, biological safety cabinet, or compounding aseptic isolator.
- more test requests can be seen on our website.