The United States Pharmacopeia Convention is a nonprofit, science-based organization with a mission to improve confidence in medicinal drugs and foods. By establishing standards, known as USP, the general public is assured of quality, safety, and efficacy of medical drug interventions. Influencing a wide range of industries including pharmacology, medical, food, and beverage, these standards are continually reviewed to account for the latest science and technology. As a partner to ensure public health and safety, the engineers at Vernick & Associates implement the latest industry standards to provide optimal, compliant cleanroom solutions.
The Latest in Science and Technology with USP Updates
It is our mission to keep our industry partners informed of the latest industry standards. Currently up for review is the Sterile Compounding 797 standards.
USP Sterile Compounding <797>
1. What Does Compounding Drugs Mean?
Compounding drugs is a practice of a licensed pharmacist customizing drug ingredients to create a tailored prescription for patients resulting in the desired effects.
2. What Qualifies as a Sterilized Medication?
Sterile medications are administered by injection including intravenous infusions, intraocular, and intrathecal injections.
3. Why Is a USP Standard Necessary for Compounding Sterilized Medications?
USP standards for compounding sterile preparations reduce the risk of contamination for a safe, correct dosage of medication for optimal patient benefit.
4. How Do the USP Standards Ensure Safety?
The USP standards specifying facility requirements and operational responsibilities include personnel training, environmental monitoring, drug storage, and drug testing.
5. How Are USP Standards Established?
A group of independent experts, including scientists and healthcare practitioners, comprise the USP Compounding Expert Committee to develop standards. After the initial standard is drafted, revisions are published for public comment. This is the prime opportunity for healthcare practitioners, policymakers, academia, and industry to offer input on standards.
6. What Is the Standard Now?
Until the new USP standard is finalized, the previous version, established on June 1, 2008, is the official standard.
Innovation and technology move at a lightning-fast pace. The pharmaceutical and medical industries implement the latest technology using science-based decision making. At Vernick and Associates, we are here to offer you the latest in cleanroom, environmental room, and modular office solutions according to the latest standards. Contact us for a free consultation to create customized solutions in your business at (216) 373-2330.
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http://www.usp.org/compounding/general-chapter-797
https://www.fda.gov/drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/