USP chapter 797: Establishing a practice standard for compounding sterile preparations in pharmacy

Kastango, Eric S; Bradshaw, Brian D

doi:10.1093/ajhp/61.18.1928

Cited by 73 publications

(36 citation statements)

References 15 publications

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“…Because compounded products are made in small quantities, the FDA has traditionally not enforced sterility testing requirements for compounded products. In addition, the US Pharmacopeial Convention (USP) is an FDA-recognized compendium that sets standards for pharmacies involved in the compounding of sterile products [8,9]. According to USP Standard 797 Pharmaceutical Compounding-Sterile Preparations, compounding personnel are responsible for ensuring that compounded sterile products are "correctly sterilized."…”

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confidence: 99%

An Outbreak of Postoperative Gram‐Negative Bacterial Endophthalmitis Associated with Contaminated Trypan Blue Ophthalmic Solution

et al. 2009

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We report 6 cases of postsurgical endophthalmitis due to gram-negative bacteria associated with contaminated trypan blue dye from a compounding pharmacy. Unopened trypan blue syringes yielded Pseudomonas aeruginosa and Burkholderia cepacia complex on culture, with pulsed-field gel electrophoresis patterns indistinguishable from patient isolates. Contamination of compounded medications should be considered when investigating outbreaks of postoperative endophthalmitis.

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confidence: 99%

An Outbreak of Postoperative Gram‐Negative Bacterial Endophthalmitis Associated with Contaminated Trypan Blue Ophthalmic Solution

et al. 2009

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“…Extended expiration periods should be avoided to minimize the opportunity for the growth of contaminants introduced during compounding. Under the most recently published practice standards, batch-prepared flush solutions may not be refrigerated for more than 7 days unless sterility testing of the final product is performed (10). Lack of adherence to sterile practices by pharmacies compounding injectable medications represents an important patient safety concern (7, 14, 16).…”

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confidence: 99%

“…Adherence to these guidelines, however, has left much room for improvement and suggests that conditions similar to those described in the hospital A pharmacy were not atypical of many hospital pharmacies in the United States (13). The publication in 2004 of enforceable practice standards for compounding sterile preparations was an encouraging development (10). Growing awareness and implementation of these standards are needed to further improve the safety of sterile products administered to neonates and other patients.…”

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confidence: 99%

Pseudomonas putida Septicemia in a Special Care Nursery Due to Contaminated Flush Solutions Prepared in a Hospital Pharmacy

et al. 2005

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Pseudomonas putida bloodstream infections were reported in two preterm neonates from a special care nursery. An unopened container of preservative-free heparin flush, compounded several weeks earlier in the hospital pharmacy and from the same batch that was administered to the patients, grew P. putida with a pulsed-field gel electrophoresis (PFGE) pattern identical to that of the patients' isolates. Intrinsic contamination was ruled out by the absence of similar reports from other hospitals and by sterility testing of unopened stock solutions. We investigated the in vitro persistence of P. putida in heparinized saline: even under refrigerated conditions, inocula of 10 2 and 10 3 CFU/ml exhibited growth at 21 and 35 days, respectively. These findings highlight the need for compliance with current standards of aseptic technique and quality assurance during the preparation of compounded sterile products.

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“…29 In 2004, the USP published Chapter 797: Pharmaceutical Compounding, Sterile Preparations to improve the compounding practices for all sterile preparations. 3 These guidelines specify the requirements and procedures with which all health care professionals must comply when compounding sterile preparations, and they are applicable to all practice settings. 30 The purpose of the guidelines is to "prevent harm, including death, to patients that could result from the following: 1) microbial contamination, 2) excessive bacterial endotoxins, 3) variability in the intended strength of correct ingredients, 4) unintended chemical and physical contaminants, and 5) incorrect types and qualities of ingredients in CSPs''.…”

Section: Usp Chapter 797: Implications For Anesthesiologistsmentioning

confidence: 99%

“…These guidelines were introduced in 2004 and these specify the requirements and procedures that should be used to compound these sterile preparations. 3 They have important implications for anesthesiologists and will be discussed below.…”

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confidence: 99%

Infusate Contamination in Regional Anesthesia: What Every Anesthesiologist Should Know

Head

Enneking²

2008

Anesthesia &Amp; Analgesia

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Infection can be a devastating complication of regional anesthesia. Contaminated infusate as a cause of infection in neuraxial anesthesia or peripheral nerve blockade has rarely been reported in the literature. However, it may be an important source of morbidity, especially as increasing numbers of patients are being discharged with perineural catheters and portable pumps of local anesthetic, which may infuse for several days at home. Two important issues related to infusate contamination in regional anesthesia are that of "hang-time" and sterile compounding practices. Hang-time can be defined as the maximum length of time during which an admixture preparation (infusate) can be safely administered without risk of microbiological or chemical instability. In the United States, there are currently no national guidelines on the hang-times of regional anesthesia infusates. On the other hand, guidelines for the sterile compounding of infusions used in regional anesthesia are now established by United States Pharmacopeia and The National Formulary Chapter 797, entitled "Pharmaceutical Compounding, Sterile Preparations." These guidelines have significant implications for the anesthesiologist. In this review, we examined the available literature regarding contaminated infusate as a cause of infection in regional anesthesia, to discuss strategies for the prevention of such contamination including the appropriate hang-time for infusates, and to discuss the implications of United States Pharmacopeia and The National Formulary Chapter 797 for anesthesiologists.

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USP chapter 797: Establishing a practice standard for compounding sterile preparations in pharmacy

Cited by 73 publications

References 15 publications

An Outbreak of Postoperative Gram‐Negative Bacterial Endophthalmitis Associated with Contaminated Trypan Blue Ophthalmic Solution

An Outbreak of Postoperative Gram‐Negative Bacterial Endophthalmitis Associated with Contaminated Trypan Blue Ophthalmic Solution

Pseudomonas putida Septicemia in a Special Care Nursery Due to Contaminated Flush Solutions Prepared in a Hospital Pharmacy

Infusate Contamination in Regional Anesthesia: What Every Anesthesiologist Should Know

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