USP 797
Terms
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- product
- a commercially manufactured sterile drug or nutrient that has been evaluated for safety and efficacy by the FDA. Are accompaigned by full prescribing information, which is commonly known as the FDA-approved mfg's labeling or product package insert.
- New USP 797 Hoods
- Barrier Isolators (totally enclosed, self-contained)
- Problems with TAB
- didnt provide the degree of specificity that most pharmacy practitioners wanted (this impeded integration and general acceptance by some RPh), recommendations were unnecessary, excessive, costly, and time-consuming.
- Old TAB Hood
- Horizontal (open) and Vertical for chemo (open with a crack)
- ASHP
- American Society of Health-System Pharmacists
- USP 797
- United States Pharmacopeia chapter 797
- Sterile Drug Products for Home Use CHAPTER 1206
- final version, to provide specific practice standards and operating guidelines for CSPs.
- Technical Assistance Bulletin (TAB)
- furter defined the level and extent of recommended quality assurance measures that should be used when compouinding sterile preparations. (equipment and setup, compounding personnel gowning procedures, cleaning procedures, types of products utilized, and the length of product storage)
- evaluate use of alternative products
- the Institue for Safe Medication Practices (ISMP) strongly recommends the use of prefilled or premade medication dosage forms asd a means to improve patient safety, frozen premixed med and unit-of-use closed transfer packaging.
- How to get into compliance
- determine risk level, perform gap analysis, develop an action plan, evaluate the use of alternative products, and reassess workload of compounding personnel.
- USP convention
- held once every 5 yr to bring together USP's volunteer members to discuss and decide on issues relating to USP's future. Members view reports and presentations from the last convention held.
- preparation or compounded sterile preparation (CSP)
- a sterile drug or nutrient prepared in a licensed pharmacy or other health care related facility puruant to the order of a licensed prescriber, which may or may not contain sterile products.
- 2001, US supreme court ruled that section 503A of FDAMA
- unconstitutional, creating vacuity of regulation for pharmacy profession and FDA regarding CSPs.
- 1995, ASHP conducted national survey ofquality assurance for pharmacy-prepared sterile preparations as a follow-up to the TAB.
- results indicated that very few pharmacies were equipped with adequaely controlled compounding environments, and that most RPh were not performing critical quality assurance checks (i.e. environ. monitoring, end-product testing, and process validation).
- January 1, 2004
- USP 797 introduced and became enforceable by FDA; sterile compounding is defined in the introduction of the ch. and clearly differs from nonsterile compounding.
- 1998, Food and Drug Administration Modernization Act (FDAMA), section 503A "Pharmacy Compounding"
- limited the scope of pharmacy compounding and was designed to protect patients from the sometimes unnecessary use of extemporaneously compounded producs prepared by pharmacists and granted the FDA power to identify certain drugs that were difficult to compound and for which compounding could adversely affect patient safety or drug effectiveness.
- CSP
- compounded sterile preparations
- determine risk level
- most pharmacies perform low and medium risk compounding. if bulk, nonsterile powders are used, high-risk compounding is being performed,
- 1960s and 1970s the practice of pharmacy was evolving
- Emphasis was placed on patient safety after patient injuries and deaths related to medication delivery adn sterile compounding issues were reported.
- intent of USP 797
- to prevent harm and fatality to patients that could result from: microbial contamination, excessive baterial endotoxins, large content errors in strength of correct ingredients, incorrect ingredients in CSPs.
- reassess workload of compounding personnel
- consolidating workloads from point-of-care locations, moving compounding to central pharmacies from satellite pharmaies, centralizing compounding activities can improve CSP quality an dconsistency while reducing costs through ensureing employee competency and facility requirements.
- revisions to USP 797
- 1. the SCC considrs internal and external comments; 2. draft containing both current official content and proposed revisions is published in pharmacopeial forum (PF); 3. period of several weeks elapses for opportunity to recieve public comments; 4. the SCC reviews received comments, then determines whether additional revision is necessary before the next version is published in PF as an Interim Revision Announcement (IRA), which bears a date for official USP adoption.
- FDAMA
- Food and Drug Administration Modernization Act
- Dispensing Practices for Sterile Drug Products Intended for Home Use
- 1992 draft recommendation issued
- perform gap analysis
- compare current pharmacy compounding operations with those described in chapter 797
- 2000, Guidelines on Quality Assurance for Pharmacy-prepared Sterile Products
- revised TAB, expanded on original doc and provided further EVIDENCE that pharmacists and technicians should improve the safety and accuracy of CSPs.
- develop an action plan
- revised policies and procedures should reflect actual day-to-day operations and practices, such as: hand washing, gloving, gowning, didactic and skills-based training, competency of staff, aseptic technique, media-fill validation, proper housekeeping (cleaning and sanitizing) and environmental monitoring for microbes
- 1990s, ASHP, USP, and NABP
- issued practice recommendations in an effort to provide a professional mandate and practice assistance to pharmacists and technicians who compounded sterile preparations.