Terminology To get started in this article, there are some terms that should be defined. Prescriptions and over-the-counter medicines and other healthcare products sold in the United States are required to follow the standards in the USP-NF. The USP also sets standards for food ingredients and dietary supplements. Chapters in the USP that are listed as below are considered enforceable, while chapters enumerated as or greater are considered guidelines. USP – USP Chapter , Pharmaceutical Compounding-Nonsterile Preparations, codifies the rules pharmacists and pharmacy technicians must follow when compounding nonsterile formulations intended for humans and animals. USP Chapter describes the procedures and requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded. USP – USP Chapter , Pharmaceutical Calculations in Prescription Compounding, provides general information on the mathematical concepts required for compounding pharmaceutical preparations. The BOP sets standards, roles, and requirements for pharmacy personnel and practice setting in their state.
The container used depends on the physical and chemical properties of the compounded preparation. Sterility Assurance of sterility in a compounded sterile preparation is mandatory. Stability Criteria and Beyond-Use Dating The beyond-use date is the date after which a compounded preparation is not to be used and is determined from the date the preparation is compounded. Because compounded preparations are intended for administration immediately or following short-term storage, their beyond-use dates may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products.
If an official USP or NF ingredient is not available, the pharmacist should use professional judgment in the selection of an alternative source so that the safety and purity of the ingredient is assured.
Emergency Room Technician Division: Regular, Full Time Opening Date: Sunday, October 8, Closing Date: Performs other duties related to the provision of care as assigned after appropriate training. Prepares instruments and supplies requires in the suturing of wounds. Assists the physician in procedure such as prepping, sponging, cutting of sutures, and application of dressing. Provides instructions to patients regarding the usage of crutches.
Performs removal of orthopedic casts, sutures, and dressing.
Sterile Compounding Pearls of Knowledge – August 2017 Edition
Results of our survey on drug storage, stability, compatibility, and beyond use dating March 22, ISMP would like to thank the practitioners, mostly pharmacy directors and managers, staff pharmacists, clinical pharmacists, and medication safety pharmacists, who responded to our recent survey on drug storage, stability, and beyond use dating of injectable drugs. We conducted the survey to learn more about what resources pharmacists rely on to guide drug storage, stability, and beyond use dating.
We were specifically interested in learning about conditions that may result in unnecessary waste of drugs during the ongoing drug shortage crisis or waste of very expensive medications given the ever rising cost associated with healthcare.
Several aspects of barrier isolation and filtered unidirectional airflow in work environment must be understood and practiced in the compounding process.
Our hospital wants the mixing to be done by a pharmacist, that it is safer and more standardized for patients. What is your take on this? USP is a private entity that develops guidelines for compounding of medications. The Code of Pharmacy has endorsed the USP recommendations and preparation of vaccines is under pharmacy supervision in hospitals. The practice parameters and independent legal review judged that if the policies recommended in the practice parameters are followed these are equivalent to the USP guidelines for allergy vaccines.
I have copied a series of questions from the archives of Ask The Expert that address some of the issues raised by your question. If so, how does one advance the dose if there is a new mix every 30 days? The individual allergist who componds vaccines in the office is not under these guidelines but under the recommendtions of the Joint Task Force who is responsible for our Allergy Parameters.
We have dealt with this issue on several occasions previously on our website. The most comprehensive answer to the question is copied for you below. In conversations with other physicians under these guidelines they have increased the frequency of injections to advance the dose. Thank you again for your inquiry and we hope this response is helpful to you.
We bring the highest level of quality and attention to detail to our clients to assure that their analytical method development and validation projects are successfully executed. There are standard organisms used for this test. Testing to show the preservative is effective should include out to and including the beyond use date. In addition to the standard organisms, it is always good practice but not required to test the effectiveness of the preservative against organisms isolated from the facility in which the product is compounded.
DYNALABS can work with the customer to help determine if testing of resident organisms found within the compounding facility is feasible and beneficial to them.
We bring the highest level of quality and attention to detail to our clients to assure that their analytical method development and validation projects are successfully executed.
The BUD required on each package e. The processing and packaging of ingredients as well as environmental storage and transport conditions are the main factors affecting chemical and physical stability. Different factors, such as contamination control proper hand hygiene and garbing, material handling and proper conduct and aseptic technique of compounding personnel , sterilization procedures, and environmental cleanliness are the main determinants of sterility.
CSPs are rarely subjected to the extensive scientific testing required for determination of expiration dates for commercially manufactures drug products. Therefore, particular CSPs may be: In conjunction with those factors, the Low, Medium and High microbial contamination risk levels were determined based on the following: The resulting relatively short default storage time limits for CSPs provide a high probability of sterility assurance without sterility testing evidence.
This is one of the major differences between CSPs and products prepared according to CGMP requirements for commercially manufactured drugs. The following time limit definitions should be used for CSPs: The BUD also specifies the time before which a CSP must BEGIN to be administered to minimize risk of patient harm from possible microbial contamination or ingredient loss to a sub-therapeutic strength. Hang Time ends when the CSP infusion is completed or discontinued.
Destruction of Unwanted Medications 1. What are my options for disposing of unwanted medications? A small number of medicines may be especially harmful if taken by someone other than the person for whom the medicine was prescribed. Many of these medicines have specific disposal instructions on their labeling or patient information leaflet.
Secundum artem Extemporaneous compounding, often just called compounding, is a necessary skill for many pharmacists and pharmacy technicians.
Classification of air cleanliness. For example, particles of 0. Barrier isolators provide a suitable environment by restricting any ambient air from the work chamber. These systems are not as sensitive to external environments as the HEPA-filtered unidirectional airflow units. Several aspects of barrier isolation and filtered unidirectional airflow in work environment must be understood and practiced in the compounding process. Policies and procedures for maintaining and working in the prescribed conditions for aseptic processing must be prepared, updated, maintained, and implemented and are determined by the scope and risk levels of the activities undertaken in the SP compounding operation.
In general, the CSP work environment is designed to have the cleanest work surfaces horizontal or vertical clean benches, biological safety cabinets, or isolators located in a buffer area, which is preceded by an anteroom that provides a clean area for donning personnel barriers, such as hair covers, gloves, gowns, or full clean-room attire. The class limit of the buffer or core room has to be demonstrably better than that of ambient air to reduce the risk of contaminants being blown, dragged, or otherwise introduced into the filtered unidirectional airflow environment.
For example, strong air currents from opened doors, personnel traffic, or air streams from the heating, ventilating, and air-conditioning systems can easily disrupt the unidirectional, columnar airflow in the open-faced workbenches.
Alabama Board of Pharmacy
Relates to State Board of Pharmacy, relates to sterile compounding, relates to permits. The bill contains the following provisions. The bill provides a definition for “compounding pharmacy” and describes sterile compounding pharmacies and non sterile compounding pharmacies.
Mopping may be performed by trained and supervised custodial personnel using approved agents described in the written procedures.