In 2012, a multistate meningitis outbreak was traced to a contaminated compounded medication. In order to ensure patient safety and raise the quality of compounded medications, many boards of pharmacy decided to enhance and strengthen compounding regulations. To support healthcare organizations in complying with these requirements, the Joint Commission has developed a new Medication Compounding Certification program.
Pharmacy compounding is the art and science of preparing personalized medications for patients. Compounded medications are produced per practitioner prescription in which individualized, specific, and precise ingredients are mixed together in the exact strength, dosage, and form required by the patient.
- Preparation of drug dosage forms for human or animal patients
- Preparation of drugs or devices in advance of prescription drug orders, or on the basis of regularly observed prescribing patterns
- Reconstitution of commercial products that may require the addition of one or more ingredients
- Preparation of drugs or devices for the purposes of research, teaching, or chemical analysis
- Preparation of drugs and devices for prescriber’s office use where permitted by federal and state law
(from: Guidelines for Compounding Practices, Chapter 1 [PDF])
According to the Joint Commission, compounding pharmacies that provide sterile and non-sterile compounding services are eligible to apply for certification. An earned certification is good for two years. This certification is open to all compounding pharmacies operating in or shipping to states with regulations that require compliance with U.S. Pharmacopeial Convention (USP) General Chapters <797> and/or <795>.
The program was developed to help healthcare organizations ensure compliance with Joint Commissions and USP standards. These standards include those related to the process, testing, and verification of compounded sterile and non-sterile preparations.
- People: Emphasis on training, proper use of personal protective equipment (PPE), and aseptic technique
- Product: Focus on the sterility of base products, beyond-use dates, and labeling
- Environment: Attention to airflow, buffer areas, guidelines for cleaning and documentation, and storage
Demo Dose® SIMBASE is our newest addition to the Pocket Nurse® Demo Dose family of products for pharmacy education to help programs comply with accreditation standards. These bases serve as the vehicle into which “active” ingredients may be incorporated to teach students the theory of compounding.
For instructional use only. Not for human or animal use.