In terms of the built environment, USP 795 is much easier to accommodate than USP 797 and USP 800 because the latter two standards involve the creation of clean rooms with ISO requirements, differential pressure relationships between rooms, dedicated extraction to circumscribed locations outside the building and, in some cases, sophisticated compounding equipment that, in some cases, acts as an evacuation system for the room. Knowing that the USP 800 will become official at that time, most facilities should consider the USP 800 so that a newly built facility does not become obsolete in terms of compliance with standards after December 1, 2019. However, to cover all the bases, it is recommended that any institution considering this decision contact its state pharmacy office to verify its position on the matter. Moderate: preparation of a preparation requiring special calculations or procedures (e.g., calibration of dosage unit molding cavities) to determine component quantities per preparation or per individualized dosage unit; or the manufacture of a preparation for which stability data are not available for that specific formulation. The construction of a compounding pharmacy until November 30, 2019 involves a judgment by the hospital or the owner of a private pharmacy regarding whether to construct a facility that: As listed in USP 795, there are three categories of non-sterile preparations: The room must be supplied with two types of water: Drinking water (for washing hands and equipment) and purified water (for use in the “preparation of medicinal preparations” non-sterile when formulations indicate the inclusion of water. [and] for dishwashers and utensils”). For those who own, operate or design private hospital pharmacies and compounding facilities, the United States The standards of Pharmacopoeia Convention USP 797, Pharmaceutical Preparation – Sterile Preparations, and USP 800, Dangerous Drugs – Handling in Health Care, are known. USP guidelines for preparation prior to USP 800 were clear: use USP 795 for non-sterile preparations and USP 797 for sterile preparations. But with the introduction of USP 800, which was written to regulate the composition of all dangerous drugs, compliance with USP standards became a bit more complicated [see chart on the right]. Pharmaceutical preparation is the manufacture of personalized and personalized medicines for patients, based on the exact strength and dosage, prescribed by a doctor and prepared by a pharmacist in an appropriate environment to maintain purity and avoid contamination. In addition, the standard states that the sink(s) should be “readily accessible to the staging areas,” but it makes sense to place sinks in staging areas whenever possible. In addition to the sink, soap or detergent, an air dryer or disposable towels must be provided. There are also general standards for the room, including for waste (“stored and disposed of hygienically and in a timely manner and in accordance with .
standards”); lighting (“well-lit”); and HVAC (“controlled to prevent decomposition and contamination of chemicals” and “temperature and humidity monitoring”. for certain compound pharmaceutical components and forms, as appropriate. In addition to previous comments on storage and shelving, “all components, equipment and containers must be stored outside the floor,” a goal that can be easily achieved by incorporating a standard elevation section into the floor of all base cabinets. The above area or separate room in the pharmacy should be designated in accordance with USP 795.” Ensure the orderly location of equipment and materials to avoid confusion between ingredients, containers, labels, in-process materials and finished preparations, and are designed, arranged and used to prevent accidental cross-contamination. In addition to these water type issues, the standard states that “the sanitary system must be free from defects that could contribute to the contamination of a compound formulation.” The use of purified water would meet this requirement. This standard now focuses on USP 795 and has wide applicability because the non-sterile preparation of non-sterile drugs is carried out by both hospital pharmacies and private compounding equipment. The following are important things you should know about these standards when they relate to facility design. USP is aware of the overlap between policies. Current SPU plans call for the release of updated versions of the three policies on December 1, 2019 (revised date on which USP 800 becomes official) for coordination purposes. The SPU Committee of Experts on Magistral Preparation is responsible for the elaboration of the General Chapter . Review the work schedule and summaries of past meetings. To avoid the “cross-contamination” that the standard warns against, the non-sterile preparation should not be carried out in the sterile ISO suite. Instead, it should be done outside this suite, either in a separate area with the main pharmacy intended exclusively for this purpose, or in a separate room (with walls and a door).
How are healthcare professionals dealing with the current stew of USP policy, which includes three sets of standards where some of the standards are already official (USP 795 and USP 797) and one of the standards (USP 800) will not be official until December. 1, 2019? Compliance with these requirements – through one or two sinks and which appliances are washed with potable water and purified water if there are two sinks – should be resolved in the design process with the healthcare facility. The sterile preparation is used to make drugs that are injected into patients or inserted into their eyes. With regard to pharmaceutical facilities, USP 797 provides guidelines for the creation of an appropriate environment for the sterile preparation of hazardous and non-hazardous drugs, which includes clean rooms with established International Organization for Standardization (ISO) standards, specified pressure relationships between chambers, special suction in some cases, and many other requirements. USP 800 regulates all hazardous mixtures (non-sterile and sterile) and must therefore be read in conjunction with previous USP 795 and USP 797 standards. However, USP 800 won`t be released until 1. December 2019 officially, according to a recent extension published by USP. Although the non-sterile preparation should be carried out in environments and according to guidelines such as USP 795 to avoid contamination, the non-sterile preparation does not need to be carried out in a clean room designed according to ISO standards.
Compound drugs manufactured without the guidelines of the standards can be underpowered, superpotent or contaminated, putting patients at significant risk of adverse events or even death. The non-sterile preparation is used to make drugs that are applied to the skin or swallowed in pill form. With respect to pharmaceutical facilities, USP 795 provides guidelines for creating an appropriate environment for the manufacture of these drugs. In addition, USP 800 provides guidelines for the non-sterile preparation of dangerous drugs. Millions of drugs are assembled each year in the United States to meet the unique needs of patients, including vulnerable populations such as the elderly and children. Compounding provides tailored therapy to patients who may not be able to use commercially available formulations due to dosage requirements, allergies or rare diseases. USP develops compositional standards for non-sterile drugs to ensure benefit to the patient and reduce risks such as contamination, infection, or incorrect dosing. USP General Chapter contains standards for the preparation of high-quality non-sterile preparations.
Pharmacists choose between sterile and non-sterile preparation, depending on how the drug product is ultimately administered to the patient. Non-sterile preparation is the most common type of pharmaceutical preparation. It is carried out in many private pharmacies, as well as in all hospitals. The vast majority of private compounding plants carry out non-sterile preparations, but not sterile preparations. Important note: The currently official version of the General Chapter (last revised in 2014) remains official. Facilities designed strictly to USP 795 are generally less complicated than those designed for USP 797 and USP 800 because the 795 standards do not address sterile mixtures and/or hazardous drugs. USP 795 states that “areas used for sterile preparations shall be separated and separated from the non-sterile preparation area”. Now, the areas for sterile preparations are covered by USP 797 and USP 800 and require a completely separate ISO suite, so a separate sterile preparation area is automatically configured. Revisions to Open Forum Registration Preparedness Updates Sign up to receive updates on the preparation Simple: Produce a preparation that contains a USP preparation monograph or appears in a peer-reviewed scientific journal article containing specific amounts of all preparation components, methods and equipment, as well as stability data for this formulation with appropriate dating beyond use; or Reconstitution or handling of commercial products requiring the addition of one or more ingredients in accordance with the manufacturer`s instructions.
