After publication of the revised and new compounding standards, USP received appeals on certain provisions in , , and. Therefore, USP is postponing the official dates of the revised and , and the new general chapter until further notice. In the interim, the currently official chapters of last revised in and last revised in including the section Radiopharmaceuticals as CSPs will remain official. The decisions on the appeals to , , and do not foreclose the possibility of future revisions to these chapters. General Chapter is not subject to any pending appeals and will become official on December 1, During the postponement and pending resolution of the appeals of and , is informational and not compendially applicable. USP encourages utilization of in the interest of advancing public health.
Instead, the proposed chapter would follow a new system for assigning BUDs based on several different factors related to achieving and maintaining sterility. Read the Notice on the USP website for detailed information. Eagle provides analytical and microbiological testing services , as well as consulting to help you ensure compliance with compounding standards and regulations.
NOTICE (September ): After this article was published, USP postponed the official dates of the revised and chapters until further notice.
On June 1, , the United States Pharmacopeia USP released new and revised standards aimed at ensuring the quality of compounded medicines. In anticipation of these changes, The Compliance Team will address revisions to our existing quality standards with an anticipated release by the end of or early Excessive microbial contamination 2. Physical and chemical incompatibilities 4. Chemical and physical contaminants 5.
Use of ingredients of inappropriate quality. Microbial contamination must be addressed 2. A Designated Person s must be named who is responsible and accountable for the performance and operation of the facility and personnel in the preparation of Compounded Nonsterile Preparations CNSP 3. Storage area temperature MUST be monitored and recorded daily b. Cleaning: The process of removing soil from objects and surfaces is accomplished by manually or mechanically using water with detergents or enzymatic products.
Sanitizing: The process of reducing, on inanimate surfaces, the number of all forms of microbial life, including fungi, viruses and bacteria. Floors: No carpeting, daily or after any spills iii.
Many state boards of pharmacy include them in regulations. Pharmacists and pharmacy technicians who compound must be aware of and comply with the USP chapters and related best practices. This lesson identifies the requirements and guides compounders to comply with best practices to protect patients from harm.
USP – Nonsterile Compounding Addendum Date responsible manager/change of responsible manager inspection was performed.
HFM Daily offers blog coverage by the award-winning HFM editorial team and links to in-depth information on health care design, construction, engineering, environmental services, operations and technology. For those who own, operate or design hospital pharmacies and privately owned pharmaceutical compounding facilities, the U. However, a third standard, USP , Pharmaceutical Compounding — Nonsterile Preparations, also is significant for professionals involved in pharmacies.
Since it was originally issued in and most recently updated in , USP has governed non-sterile compounding of both hazardous and nonhazardous drugs. Half of that equation changed with the introduction of USP , which governs hazardous compounding for both sterile and non-sterile operations. Pharmaceutical compounding is the creation of personalized, customized medications for patients based on exact strength and dosage prescribed by a physician, prepared by a pharmacist in an appropriate environment to maintain purity and avoid contamination.
Sterile compounding is used for the preparation of drugs that will be injected into patients or inserted into their eyes. In terms of pharmacy facilities, USP provides guidelines for creating an appropriate environment for sterile compounding of both hazardous and non-hazardous drugs, which includes cleanrooms with specified International Organization for Standardization ISO standards, specified pressure relationships between rooms, dedicated exhaust in some cases and many other requirements.
Additionally, USP provides guidelines for sterile compounding of hazardous and non-hazardous drugs.
Consequently, the Board amended rule —8. On September 23, USP announced that the effective date of the published revisions to USP Chapters and would be delayed, and would no longer become effective on December 1, USP is considering the following appeal topics for USP Chapters and 1 beyond-use date BUD provisions in both chapters, 2 removal of the alternative technology provision from USP Chapter , and 3 the applicability of both chapters to veterinary practitioners.
In accordance with rules — On October 3, the Board convened and made the following decisions regarding enforcement:.
The United States Pharmacopeia (USP) is indefinitely postponing the effective date of three controversial USP chapters after several pharmacy.
The pharmacy shall make available special handling and packaging materials to maintain container integrity and drug stability of the prepared prescription orders, including antineoplastic or other hazardous sterile preparations, during handling and administration to the patient including:. The dispensed container for any compounded sterile preparation shall include labeling according to Maryland law and regulations, in addition to the following information that is required by federal law:.
A pharmacy compounding sterile infusion preparations shall provide a hour telephone number to allow its patients or other health care providers who may be administering its prescriptions to contact its pharmacists. Expiration or Beyond-Use Dating. In the absence of direct testing evidence, as detailed in the Stability Criteria and Beyond Use Dating section of USP Standards, the pharmacist shall use “beyond-use dating” as determined by USP Standards and reference materials as cited in Regulation.
The pharmacy shall make available special handling and packaging materials to maintain container integrity and drug stability of the prepared prescription orders, including antineoplastic or other hazardous sterile preparations, during handling and administration to the patient including: 1 A reasonable effort to provide tamper-evident packaging if appropriate to setting; 2 Proper in-transit storage consistent with preparation labeling; and 3 Delivery to the patient within a reasonable time.
The preparation of compounded sterile preparations CSPs in compliance with federal, state, and industry standards is a core function of home infusion pharmacy practice. Patients rely on the expertise of home infusion providers to ensure medications are prepared in a sterile, accurate, and safe manner. Home infusion providers must be aware of changing standards and regulations related to the professional practice of sterile compounding in order to remain in good standing with regulating bodies, and to ensure operating procedures are adequate to protect patients and employees.
NHIA strives to ensure all stakeholders are informed of the latest trends in sterile compounding regulatory and standard-setting activities, and regularly posts updated information on this site. In some states, the Board of Medicine or similar entity regulates sterile compounding that occurs in physician offices. Most pharmacies maintain active accreditation from an agency that performs rigorous inspections for compliance with state laws and internal policies.
The affected chapters— Pharmaceutical Compounding-Nonsterile Preparations; Pharmaceutical Compounding-Sterile.
USP considers adding flavoring to a conventionally manufactured product to fall within the scope of compounding, because there are known instances when flavoring components have destabilized a product. If a flavoring component is added to a manufactured product that does not contain a preservative e. If a flavoring component is added to a manufactured product that contains a preservative e. The addition of flavoring including the flavor manufacturer or product, lot number, and expiration date must be documented in the patient record notes for the prescription.
These chapters were previously scheduled to go into effect on December 1, The revised chapters will be enforced when they go into effect. USP did not set a new effective date in its announcement today. Again, USP did not set a new effective date in its announcement today. Licensure Gateway.
USP Provision The Compounding Documentation section of USP Chapter explains A reliable beyond-use date (BUD) is established to.
Compounding is an integral part of pharmacy practice and is essential to the provision of health care. Compounders must be familiar with statutes and regulations that govern compounding because these requirements vary from state to state. The compounder is responsible for compounding preparations of acceptable strength, quality, and purity with appropriate packaging and labeling in accordance with good compounding practices see Good Compounding Practices , official standards, and relevant scientific data and information.
Compounders engaging in compounding should have to continually expand their compounding knowledge by participating in seminars, studying appropriate literature, and consulting colleagues. The compounder is responsible for ensuring that the quality is built into the compounded preparations of products, with key factors including at least the following general principles.
See also Good Compounding Practices