The Evolution of Sterile Compounding Standards

Nov 07, 2016

The Evolution of Sterile Compounding Standards

Pharmacy Compounding is the art and science of preparing customized medications that are not otherwise commercially available. It is performed by or under the supervision of a pharmacist pursuant to an order from a licensed prescriber for an individual patient.

Guidelines, Standards, and Laws provide guidance to pharmacists in relation to the compounding of medicines to ensure product quality, safety and efficacy.


How it BEGAN and where is it LEADING Us


National Coordinating Committee on Large Volume Parenterals (NCCLVP) developed and recommended standards of practice for the preparation, labeling, and quality assurance of hospital pharmacy admixture services


Pharmacy Profession received pressure from the FDA to address microbial contamination of compounded products in US hospitals.


FDA Alert Letter on compounding - pharmacists are responsible for conforming to cGMP and using safe packaging to ensure continued sterility during use.


FDA Compliance Policy Guide - FDA had no intention of regulating pharmacy's historic exception to compound drugs extemporaneously in reasonable quantities pursuant to prescription.


ASHP Technical Assistance Bulletin (TAB) - further defined the level and extent of recommended quality assurance measures used when compounding sterile preparations. It also addressed operating issues, such as equipment and setup, compounding personnel gowning and cleaning procedures, types of products utilized, and the length of product storage.


USP 1206, Sterile Drug Products for Home Use - provide specific practice standards and operating guidelines for CSPs.


FDA Modernization Act (FDAMA) of 1997 - creates a special exemption to ensure continued availability of compounded drug products prepared by pharmacists to provide patients with individualized therapies not available commercially.


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