Sterile preparations became official,1 which details the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all prac. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Does the pharmacy have appropriate compounding references including usp chapter 797. For all official fda inspections, the investigators must present form 482 on their.
Usp chapter 797 was the first set of enforceable sterile. Usp continues to encourage early adoption and implementation of to. As of january 2012, ceta application guides are available to ceta members as a free download. Wa pharmacy quality assurance commission 2020 responsible. Usp 797 compliance with usp 797 is our duty because. To download the complimentary usp general chapter 797 pharmaceutical compounding sterile preparations, please click here. Usp and usp 797 are standards designed to keep compounded preparations safe. Usp chapters 797 and new and revised compounding standards at issue the united states pharmacopeia usp in june 2019 released several new and revised pharmacy compounding standards. The recently published usp chapter 797, pharmaceutical compounding. State of connecticut department of consumer protection. Usp 797 is a broad regulation, covering several pharmacy policies and procedures. In 2004, usp revised the chapter, which became a general chapter devoted specifically to sterile compounding, 797 pharmaceutical compoundingsterile preparations general chapter 797 or 797.
Using usp chapter pharmaceutical compoundingsterile preparations csp is now considered the standard for sterile compounding. A timeline of sterile compounding events and actions taken. These two standards relate to the preparation of nonsterile and sterile compounded. Based on the number and significance of public comments received in response to the revision proposal published in pf 416, the usp compounding expert committee is proposing to revise this chapter. The usp chapter 797 usp 797 provides product safety and quality. Sterile preparations, became effective january 1, 2004. Usp chapter 797 requires that a compounding record be created and maintained. General chapter usp 797 establishes best practices and regulations for the. Compounding sterile preparations the ashp discussion guide on usp chapter 797. Instructions for filling out the sterile compounding. Compounding usp kastango 2012 wiley online library. Cleaning products and procedures for 797 compliance by kate douglass cleaning should generally occur from the cleanest area to the dirtiest from an iso. Usp articles, or within 10% if not specified, until their buds.
Since the fungal meningitis outbreak of 2012 and the subsequent passage into law. Compounding sterile preparations 2 executive summary on january 1, 2004, the first version of usp chapter 797, pharmaceutical compounding. Usp 797 clean room guidelines standards for sterile. Understanding usp 797 csps include the following types of preparations. Inspection, regulation, and oversight of sterile compounding pharmacies article pdf available in journal of parenteral and enteral nutrition 362. All injectable dosage forms have preservatives which is. This discussion guide is intended to assist healthsystem pharmacists with implementation of usp chapter 797 requirements. Specifically, usp published the final revised version of general chapter 797 pharmaceutical. Usp controlled room temperature range expansion desmond g hunt.
Join ceta to be able to access the below documents in. Pdf a primer on usp chapter 797 pharmaceutical compounding. This monograph will focus on usp 797 as it pertains to antimicrobial risk level. What are the differences between usp 795, 797, and 800. Massachusetts licensed pharmacies that do not engage in sterile compounding, as defined in usp 797, are not required to submit this form. Pharmaceutical compoundingnonsterile preparations331 preparation of drugs or devices for the purposes of, orequipment, and stability data for that. Review the history of usp 797 and the milestones that led to the development of these sterile compounding standards. Pharmaceutical dosage forms765 maceutical preparations, which are given elsewhere in thistent uniformity does not rely on the assumption. In an aeca, all work surfaces in the aeca where direct. No plans for compliance polling question how compliant is your site with usp 797. Usp chapter 797 requires a compound record to be created and maintained, however, does not define the. Usp 797 is a farreaching regulation that applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound sterile preparations are prepared, stored, and dispensed. Blueprint for implementing chapter 797 for compounding. Please click the button below to fill out our request a quote form.
General chapter pharmaceutical compounding sterile. Ashp guidelines on compounding sterile preparations. Those prepared according to the manufacturers label instructions that expose original contents to potential. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer. Understanding the role of water and the need to adequately remove it from cells or abrogate its ability to form. Usp quick reference guide cleaning and disinfecting. Retrace all the steps from receipt of the order through delivery to the customer bud compounding methodology. Usp chapter 797 does not define the specific elements to be included in the compounding record. Usp 797 builds upon the same 795 requirements for nhds, with the additional requirement of an externally vented laminar flow hood as a primary engineering control pec for hds. Compounding of total parenteral nutrition fluids using manual or automated. If the buds are extended, is supporting documentationtesting available for extended buds. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use. Usp 797 pharmaceutical compounding sterile preparations. Usp remains committed to keeping stakeholders and the general public informed of the progress of these standards, which are anticipated to become official on december 1, 2019.
Usp 797 and cgmps require that surface sampling be performed in all iso classified areas on a periodic basis using contact plates or swabs. Usp nf establishes standards for medicines, food ingredients and dietary supplements. Measuring progress i nitiated in 2011, the united states pharmacopeia usp chapter 797 compliance survey was developed to evaluate the degree of compliance in the united states to the sterile compounding requirements in usp chapter 797. Background on june 1, 2019, usp published major revisions to general chapters and 797.
In accordance with the rules and procedures of the 20152020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations 797. The chapter answer book provides an explanation of elements of usp hazardous drugshandling in healthcare settings and best practices to comply with the requirements and recommendations of the usp general chapter. Provide a report and recommendations for an action plan in order to meet both shortterm and longterm goals for compliance with the requirements of usp chapter 797. Developing usp general chapter 797 usp is a notforprofit, sciencedriven organization that has an established process for convening independent experts in the development and. Usp 797 compliance common challenges and potential solutions angela yaniv, pharm. Sample locations must be defined in the em plan or on a form.
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