The United States Pharmacopeia (USP) is the United States' congressionally authorized book of standards for pharmaceutical manufacturing in the United States. The most current edition of the USP includes a new chapter entitled Pharmaceutical Compounding-Sterile Preparations that sets standards for all health care professionals who prepare, store or dispense sterile preparations. Extemporaneously compounded sterile formulations are sometimes needed for symptom control in pain and palliative practice. The implications and relevance of this new USP chapter to pain and palliative care clinicians-and the importance of all clinicians understanding the implications of how their patient's compounded sterile products are prepared-are discussed.
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http://dx.doi.org/10.1300/j354v18n04_08 | DOI Listing |
Allergy Asthma Proc
January 2025
The United States Pharmacopeia (USP) Chapter 797 provides critical standards for compounding sterile preparations to ensure patient safety and medication efficacy. The latest revision, effective November 1, 2023, introduces updates particularly relevant to the compounding of allergenic extracts, which emphasizes stringent compliance measures. This article aims to review the key updates to USP Chapter 797, outline the compliance requirements for personnel and facilities, and offer strategies for staying current with these practice guidelines, leveraging resources from professional organizations such as American College of Allergy, Asthma, and Immunology and American Academy of Allergy, Asthma, and Immunology.
View Article and Find Full Text PDFZhongguo Zhong Yao Za Zhi
October 2024
Key Laboratory of Modern Chinese Medicine Formulations, Ministry of Education, Jiangxi University of Chinese Medicine Nanchang 330004, China.
Since ancient times, traditional Chinese medicine pills have occupied a key position among different dosage forms of traditional Chinese medicine. With the aims of comprehensively improving the overall quality and innovating key technologies in the manufacturing of the pills, this article elaborates on the principles and new technology applications in pulverizing, sterilization, agglomeration, forming, and drying. In addition, modern technologies such as biosensing, image analysis, texture property evaluation, and moisture analysis can comprehensively and accurately characterize the quality of key materials in the manufacturing of traditional Chinese medicine pills, thereby achieving strict control over the quality of raw materials, intermediates, and final products and further monitoring and optimizing the entire production process of pill preparations.
View Article and Find Full Text PDFJ Oncol Pharm Pract
December 2024
Division of Practice Advancement and Clinical Education, University of North Carolina at Chapel Hill Eshelman School of Pharmacy, Chapel Hill, NC, USA.
Introduction: The purpose of this study was to assess and compare the effectiveness of seven different closed system transfer device (CSTD) product lines following the 2015 NIOSH Vapor Containment Performance Protocol, using a Gasmetâ„¢ DX5000 Terra multigas FTIR analyzer.
Methods: Seven different CSTD systems were assessed using a two-task evaluation on their capacity to contain the NIOSH-specified challenge agent, 70% isopropyl alcohol (IPA). Task 1 simulated reconstitution and compounding steps while Task 2 simulated compounding and administration steps.
Int J Pharm Compd
December 2024
Occupational and Environmental Safety, Duke University/Duke University Medical Center, Durham, North Carolina.
Selecting an appropriate sanitizer (i.e., "rub") for application to hands and gloves before and, if necessary, during sterile compounding is as important as is its consistent and judicious use.
View Article and Find Full Text PDFInt J Pharm Compd
December 2024
Tri-State Compounding Pharmacy, Cincinnati, Ohio.
Wound care is one of the main concerns of patients with diabetes. This case involves a 65-year-old woman with a wound (4 cm x 2 cm) on her right foot, underneath the big toe. The patient had not been successful in healing this wound using conventional preparations for a year.
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