Millions of medications are compounded each year in the US to meet the unique needs of patient, including vulnerable populations such as seniors and children. Compounding provides tailored therapy to patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases. Compounded medications made without the guidance of standards may be sub-potent, super potent or contaminated, exposing patients to significant risk of adverse events or even death. USP develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. USP is a not-for-profit, science-driven organization that has an established process for convening independent experts for the development and maintenance of healthcare quality standards. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard setting process.
Compounded preparation monographs assist practitioners in compounding formulations in a consistent manner, in conformance with USP standards. It was revised in and Handling HDs includes, but is not limited to, the receipt, storage, compounding, dispensing, administration, and disposal of sterile and nonsterile products and preparations.
Some general notice provisions relate to compounding.
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Section 3. When a compounding preparation fails to meet USP-NF identity standards, or contains added substances that interfere with the monograph tests, it must have a clearly differentiating name, different from the USP-NF name. These laws are enforced by the respective state boards of pharmacy and health.
Beyond-Use Dates. General Chapter > defines BUDs as "either the date or hour and date after which a CSP must not be used. The BUD is determined from the date/time that the preparation of the CSP is initiated." 3 The CSP must be labeled with the BUD, which clearly shows the date or time after which the preparation cannot be used. This is to ate and consolidate the extended use date information posted previously (6/15/17 to present). Due to continued intermittent supply interruptions of critical drugs, FDA is alerting. First Breach of Manufacturer's Container Take, for example, the beyond-use date (BUD) for tablets taken from a manufacturer's large container and repackaged into smaller containers. According to the guidance, FDA wants the BUD for those repackaged tablets to be the earliest of 6 months from the first time the large container is opened.
In the past, enforcement of pharmacy compounding has primarily resided at the state level through pharmacy and health boards. Facilities and compounding professionals in organizations that are surveyed by accreditation organizations e. The primary accrediting body for hospitals and health centers in the United States is The Joint Commission.
The Joint Commission is a not-for-profit organization that accredits and certifies nearly 21, health care organizations and programs in the United States.
The Joint Commission hospital accreditation includes an onsite survey by a Joint Commission survey team at least every 3 years. It is important to note that a LAFW or CAI must not be used for the compounding of chemotherapy drugs, because that would not protect the operator from potential contamination.
Sterile compounding facilities are designed to provide appropriate working environments to control and minimize contamination and to be well-lighted and comfortable for compounding personnel. There are two types of facilities used for compounding nonhazardous sterile preparations: 1 a cleanroom suite or 2 a SCA.
ISO classifications limit the number of particles in the air. The smaller the ISO class, the fewer particles allowed, hence the cleaner the area needs to be.
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The positive pressure rooms are at a higher air pressure than adjacent spaces, which forces the airflow out of the rooms. An SCA is a separate area or room that is designed for preparation of nonhazardous CSPs those with a hour room temperature or hour refrigerated beyond-use time ; it is not required to be an ISO-classified cleanroom. This is no longer permitted. Antineoplastic agents in NIOSH Table 1 must be compounded in facilities that protect the compounder from contamination.
USP Chapter defines Beyond Use Date (BUD) as the date after which a compounded nonsterile preparation (CNSP) should not be used. The BUD is determined from the date the CNSP is compounded. When determining BUD, the pharmacist must take into account stability information regarding the specific drug(s) and specific CNSP. Beyond-use dates (BUDs) are the date or time after which a compounded sterile preparation (CSP) or compounded nonsterile preparation (CNSP) may not be stored or transported and are calculated from the date or time of compounding. Why are Beyond-Use Dates Necessary? BUDs help decrease the risks that may be posed to keitaiplus.com Size: KB. BEYOND USE DATING FOR STERILE COMPOUNDING. Beyond Use Date (BUD) is very different from expiration date. USP Chapter defines BUD as the date or time after which a compounded sterile preparation (CSP) may not be stored or transported and is calculated from the date or time of compounding. Expiration date is a manufacturer defined term based on very specific testing used for File Size: KB.
The anteroom for HD preparation requires a higher level of cleanliness ISO 7 than required for nonhazardous drugs ISO 8 because the air entering the negative buffer room needs to be at least as clean as the air in the buffer room. All HDs except those agents other than antineoplastics that are specifically exempted by the facility must be compounded in a negative pressure room to protect compounding personnel.
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Other considerations for facilities include design, air handling, sink placement, and finishes. Facilities must be designed to minimize contamination of surfaces, to promote effective cleaning, to limit unnecessary personnel and materials traffic, and to include only furniture and equipment that is necessary for compounding.
A key component is airflow and control of particulate matter. This is achieved using HEPA filtering and air handling systems that are designed to meet ISO classification standards, sweep away the particles from the compounding area and the compounders, and maintain the required facility pressure differentials. Water sources sinks and drains may not be placed in the buffer area. Finishes on ceiling, wall, and floor surfaces must be easily cleaned and disinfected, smooth, and impervious.
Training and monitoring of compounding personnel are critical components for safe and effective sterile compounding.
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Training must be conducted by expert sterile compounding personnel and must be documented. As with any personnel training, documentation of the training is crucial for recordkeeping purposes and certification.
Media fill testing shows that a compounder can aseptically mix a CSP at the facility using sterile fluid culture media. The media fill test is completed before personnel are allowed to compound independently.
It must then be conducted at least every 6 months. Initially, it must be passed before personnel are allowed to compound independently. Direct touch contamination is the most likely source of introducing microorganisms into CSPs. The initial gloved fingertip test is performed immediately after the compounding employee completes the hand hygiene and garbing procedures. This test must be performed on three separate occasions with absolutely no CFU growth within the required incubation period.
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Compounding personnel must requalify every 6 months. Millions of medications are compounded each year in the US to meet the unique needs of patient, including vulnerable populations such as seniors and children.
Compounding provides tailored therapy to patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases. Compounded medications made without the guidance of standards may be sub-potent, super potent or contaminated, exposing patients to significant risk of adverse events or even death.
USP develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing.
USP is a not-for-profit, science-driven organization that has an established process for convening independent experts for the development and maintenance of healthcare quality standards. The January 12 repackaging guidance advises pharmacies to take into account the in-use time stated in an FDA-approved drug product's labeling when assigning a BUD to a repackaged sterile drug product.
The expiration date on the label 31 Do not refrigerate 31 Novolin 70/30 The expiration date on the label 42 42 Humalog 75/25 The expiration date on the label 28 28 Humalog 50/50 The expiration date on the label 28 28 Novolog 70/30 The expiration date on the label 28 28 Long-Acting Insulin Lantus (glargine) The expiration date on the label 28 Important ates. May 26, - ate on stakeholder engagement activities related to beyond-use-date (BUD) provisions in General Chapters & March 12, - Appeals Panel issues decisions on the Appeals to USP, and (see FAQs on USP Compounding Appeals); September 23, - Revised General Chapter is postponed until further notice. When an official monograph isn't present, a systematic approach to assigning the date can be as follows: Step 1. Beyond use dates should be in accordance with the manufacturer's approved labeling. This means that the product Step 2. When this is not possible, a pharmacist ideally consults with.
If the labeling does not specify an in-use time or if the sterile drug product being repackaged is an unapproved product on FDA's drug shortages list, the guidance advises pharmacies to assign a BUD according to the standards in the proposed revision of USP chapter or the expiration date on the original container, whichever results in the shortest time frame. Potassium chloride injection has been on FDA's drug shortages list for nearly 5 years.
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Neither manufacturers' labeling states an in-use time per se; rather, users are instructed to discard the original container no more than 4 hours after first penetrating its closure. The proposed revision of USP chapter -the apparent next source of information on assignment of the BUD in this case-says the in-use time for a pharmacy bulk package is "[a]s specified by the manufacturer" if opened, stored, and used for sterile compounding in an environment with International Organization for Standardization class 5 or better air quality.
Among FDA's other expectations of pharmacies is that they repackage drug products in accordance with the handling and storage instructions in FDA-approved labeling. Propofol injectable emulsion, the guidance explains in a footnote, has labeling stating that the drug "undergoes oxidative degradation in the presence of oxygen and is therefore packaged under nitrogen. Thus, a pharmacy that repackages propofol and exposes it to oxygen during the process is producing a drug product that conflicts with FDA-approved labeling, the guidance states.
FDA in cited an outsourcing facility, formerly a compounding pharmacy, for misbranding propofol.
The warning letter said the agency's investigators found that the facility did not repackage propofol in "tight containers under an atmosphere of inert gas, which is the standard for packaging and storage of propofol established in the monograph by [USP].