The 18th of January in 2019 The United States Pharmacopeial Convention (USP) Standard 797 is the regulation that governs the sterile manufacture of compounded medications. Compounding of potentially dangerous as well as non-dangerous pharmaceuticals is addressed in USP 797, with a particular emphasis placed on the prevention of contamination of sterile substances and settings.
- This guideline has been put into place to safeguard the safety of patients and to cut down on the dangers that are connected with the compounding of medications.
- These hazards include contamination, infection, and the administration of an erroneous dosage.
- The standard contributes to the guarantee that patients will get pharmaceuticals of sufficient quality that are free of contaminants.
This standard is applicable to all pharmacies that make compounded sterile preparations (also known as CSPs); this includes pharmacies located within hospitals, radio or nuclear pharmacies, chemotherapy units, and operating rooms. The purpose of the standard is to protect patients from potential dangers such as microbiological contamination, bacterial endotoxins, variations in the potency of the components, as well as chemical and physical contaminates.
What does USP 797 stand for?
What exactly is the USP 797? – The notation USP 797 refers to the chapter 797 of the USP National Formulary titled “Pharmaceutical Compounding – Sterile Preparations.” It is the first set of sterile compounding rules that are actually enforceable, and it was released by the United States Pharmacopeia (USP).
What is the overall objective of USP 797?
The purpose of the United States Pharmacopeial Convention (USP) is to promote circumstances and procedures that guarantee the clean and sterile manufacture of medicines for the sake of the patient’s safety. The USP establishes minimal standards of quality and practice for CSPs that are based on scientific research.
Who does USP 797 protect?
USP 797 is a standard that was developed to safeguard patients as well as pharmacists. USP 797 divides sterile compounding into three different risk categories: low, medium, and high. It is applicable to any and all pharmacies, including those found in hospitals and retail settings, that create compound sterile preparations.
To be more specific, the purpose of this chapter of 797 is to protect patients from suffering serious injuries or even death as a result of microbial contamination (non-sterility), an excessive amount of bacterial endotoxins, or significant content errors in the strength of correct or incorrect ingredients in compound sterile preparations.
The following changes are the result of the most recent modification to this regulation: Qualifications, calibrations, and certifications of both the equipment and the classified areas Prerequisites for obtaining certification in controlled environments such as clean rooms Testing carried out as part of the certification process for the facility Situations that call for investigations and corrective actions to be taken
What are the 3 risk levels USP 797?
As of right now, USP 797 (2008) is the current official chapter, and it categorizes risks as being either low, medium, or high.
What does USP stand for in pharmacy?
Over 5,000 quality standards for medications, both chemical and biologic, active pharmaceutical ingredients (APIs), and excipients are included in the United States Pharmacopeia – National Formulary (USP-NF). These standards may be found in the USP-NF (inactive ingredients).
It is the single most comprehensive source available anywhere in the world for drug quality standards. The standards contained in USP-NF are used in order to assist in ensuring the quality of medications and the components that go into them, as well as to safeguard the safety of patients. The United States Pharmacopeia (USP) is the official quality standard that applies to medications sold in the United States.
In addition to this, USP is applied in over 140 nations all over the world and has been included into the legal systems of over 40 countries. The following are the three categories of quality criteria that are included in USP-NF for prescription medicines:
- A medicine’s monograph will include the quality standards that are expected of it, including those for its identification, potency, purity, and performance. In addition to this, the tests that are utilized to confirm that a drug and its constituent parts satisfy these criteria are also described.
- In order to assist the product development and manufacturing processes for novel, generic, and biosimilar medicines, the General Chapters contain information that is generally relevant to the pharmaceutical industry on approved procedures, tests, and methodologies.
- In addition to monographs and general chapters, material reference standards are used to the process of determining whether or not a drug and the components that go into it are able to successfully complete tests designed to validate that they comply to quality criteria.
Is USP 797 mandatory?
USP 797/USP 800 Still in Flux – The requirements for pharmacies are in the process of being revised, and it is possible that oncology clinics and hospital pharmacies may soon be held accountable for complying with the revised criteria for sterile compounding and the safe handling of hazardous pharmaceuticals.
The US Pharmacopeia (USP) chapters on Sterile Compounding (USP 797) and Safe Handling of Hazardous Drugs (USP 800) are only legally enforceable when an entity with authority over the medical practice or hospital (for example, a state Board of Pharmacy, a state Board of Medicine, or an Occupational Safety department) chooses to make elements of those chapters enforceable.
Sterile compounding refers to the process of preparing medications in a sterile environment. Safe handling To this day, the majority of state boards of pharmacy have decided to establish their own own standards based on USP 797. There are less than five states that have passed laws mandating safe handling; however, these laws are still being worked on and have not been finished, despite the passage of many months.
- Because USP 800 has not yet been made official, several state boards of pharmacy have decided not to implement or enforce it.
- Instead, they are likely to consider applying their own standards that are linked to the aspects of USP 800 that are being addressed.
- These two chapters are currently being revised.
Midway through 2018, the United States Pharmacopeia (USP) 797 standard will be updated and made available for public comment. The USP Expert Committee that is responsible for writing these chapters has the goal of aligning USP 797 with USP 800, which has been presented but has not yet become official.
- This is due to the fact that USP 800 has significant conflicts with the most recent version of the official USP 797 document.
- On the topic of the change of USP 797 and, by extension, the components of USP 800, a sizeable public reaction is expected, and extensive comments are likely to be filed in response.
Even though the actual language of USP 797 and USP 800 will be subject to change until the planned “official” date of December 2019, practices and hospitals are currently looking at the draft standards in order to identify any gaps that currently exist and get ready for the implementation of these standards.
- In spite of the fact that the standards may or may not be legally enforceable, they do give a useful outline of factors that should be considered for improved practice.
- Although there is a possibility that some of the components may be disputed due to a lack of supporting data, many of the components make perfect sense, and gaps exist in the majority of medical offices and pharmacies.
It is common practice to shorten conversations regarding pharmacy standards to the phrase “USP 800,” however most stakeholders are now aware that this nomenclature refers to a broader process of examining pharmacy standards in general and not simply the application of USP 800 specifically.
What are USP 797 guidelines?
The publication and execution of the quality system specified in the United States Pharmacopeia Chapter: Pharmaceutical Compounding – Sterile Preparations can be directly attributed to the improved safety outcomes for patients who receive compounded sterile preparations (also known as CSPs).
- The purpose of the United States Pharmacopeial Convention 797 (USP 797) is to establish minimum practice and quality standards that are required of any person or organization that is engaged in the storing, handling, preparing, or transporting of controlled substances for patients.
- By following to the requirements outlined in USP 797 in an exacting manner, pharmacies can lessen the likelihood of causing patients or staff members to be injured.
The USP 797 standards include three crucial aspects, namely personnel, engineering/facility design, and environmental controls. This chapter outlines the conditions that must be met in each section in order to guarantee sterile and risk-free compounding.
Which USP 797 is the current?
This article was written by Robert Campbell, PharmD, BCSCP, director of clinical standards interpretation for Hospital/Ambulatory Programs. The Joint Commission is still being asked questions about USP Chapter 797 and related amendments, in addition to inquiries about expectations for compliance with USP Chapter 800.
Previous remarks made by The Joint Commission in relation to the compounding of medications have been rendered obsolete by this more recent recommendations. Remanded is the 2019 revision of USP 797. The United States Pharmacopeial Convention (USP) announced on March 12, 2020, in a publication, that the 2019 modification of USP 797 had been remanded as a consequence of a final appeal hearing.
As a result, the USP 797 amendment that was published in 2019 is no longer legally binding. The chapter will be reopened as a result of the ultimate judgment about the appeal, and it is currently uncertain which aspects of the chapter will be altered.
When it comes to evaluating organizations that have already finished remodeling according on the 2019 revision, how will The Joint Commission do so? Organizations that had begun construction Cto be compliant with the 2019 revision to USP 797 will meet or exceed the 2008 version of USP 797 from a structural perspective, with one exception.
This will be the case for organizations that had begun construction Cto be compliant with the 2019 revision to USP 797. The only difference between the 2008 version and the 2019 revision is that the 2008 version does not permit Category 1 compounding in a segregated compounding area (SCA), but the 2019 revision does.
This is due to the fact that the compounding process was handled in the 2008 edition from the perspective of the amount of complexity of the compounded product (number and type of products prepared together). Compounding was organized into several categories based on the place where the product was made as part of the 2019 revision.
Due to the fact that the two chapters approach compounding in quite different ways, there are a few distinct ways in which one might carry out the procedures that are defined as Medium Risk Compounding in the 2008 edition. In accordance with the current edition of USP 797 (2008), the Sterile Compounding Area (SCA) is only permitted to manufacture low-risk, non-hazardous, compounded sterile items.
Despite this, the USP has issued an interim advice that enables companies to continue doing medium-risk compounding in a SCA even while the COVID-19 pandemic is ongoing. As soon as the government has announced that the public health emergency has passed, organizations will once again be compelled to comply with the version of USP 797 that was published in 2008.
How will The Joint Commission look at the compounding of potentially dangerous medications? If the 2019 amendment to USP 797 had gone through as planned, USP 800 would have become enforceable. As a result of the change being remanded, USP 800 will continue to be informative for the time being.
- USP 800 will become enforceable as soon as a new modification of 797 is made public, at which point businesses will be required to bring themselves into compliance with USP 800.
- During this interim period, businesses have the option of either utilizing the version of USP 797 from 2008 as advice for the handling of hazardous drugs or adopting USP 800.
Both of these options are available to them. Organizations that choose to adopt USP 800 should be aware that there is a conflict between the 797 and 800 on the handling of hazardous medications. Organizations that adopt USP 800 should follow the guidance listed within that chapter.
- If an organization chooses to adopt USP 800, it should be aware that there is a conflict between the 797 and 800 on the handling of hazardous medications.
- Given the architecture of the USP, only a portion of USP 800 would become legally enforceable.
- The Joint Commission will only conduct a survey to determine compliance with those aspects of USP 800 that would have been enforceable, coupled with any extra requirements that are outlined in the organization’s policy.
This is done while analyzing compliance with USP 800. Some examples of these fields are as follows, however the list is not exhaustive: Compounding staff facility and engineering controls (including microbiological sampling) beyond use dates training of staff garbing of personal protective equipment of compounding staff facility and engineering controls During the COVID-19 pandemic, are there any provisions relating to drug compounding that should be taken into consideration? Your firm may wish to take into consideration the interim guidelines that was provided by the USP in order to aid with the reduction of drug shortages and waste.
- Because the Joint Commission will not ban these provisions, an organization that has decided to apply this guidance during the public health emergency will not be assessed as being out of compliance with the Joint Commission’s requirements for these provisions.
- Robert Campbell, who holds the degrees of PharmD and BCSCP, is now serving in the roles of director of Medication Management and director of Clinical Standards Interpretation Hospital/Ambulatory Programs.
Before taking on these responsibilities, he worked at The Joint Commission as the pharmacist in charge of Clinical Standards Interpretation in the Division of Healthcare Improvement. Campbell is a reviewer for the Medication Compounding Certification Program as well as a field representative for The Joint Commission’s Hospital Accreditation and Critical Access Hospital Accreditation Programs.
- Additionally, Campbell conducts surveys on behalf of The Joint Commission as a Critical Access Hospital Accreditation Program field representative.
- Campbell worked in health care organizations prior to joining The Joint Commission, where he held leadership positions with oversight responsibilities for performance improvement, accreditation readiness, risk management, infection control, medical staff services, as well as inpatient and outpatient pharmacy services.
In addition, Campbell was responsible for infection control. USP Resources accessible Multiple New Developments The USP Resources. Important Updates Sign up for updates FAQs concerning appeals Conclusions Regarding Appeals
When did USP 797 go into effect?
It was on January 1, 2004, that the first version of the USP Chapter on Pharmaceutical Compounding: Sterile Preparations became official.1 This chapter, which outlines the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all practice settings in which sterile preparations are used, provides information on the procedures and requirements for compounding sterile preparations.
What medications must be sterile?
Sterile Preparations and Compounding in the Pharmaceutical Industry Medications that are given through injection, intravenous infusion (IV), intraocular (injection in the eye), or intrathecal (injection into the spinal column) are all examples of the types of medications that are required to be sterile (injection in the spine).
What is the difference between USP 795 and USP 797?
Compounding pharmacies are required to keep a condition of control, as stated in both Chapter 795 and Chapter 797 of the United States Pharmacopeia. In Chapter 795, we cover how to apply excellent compounding practices to the process of creating nonsterile compounded formulations, whereas in Chapter 797, we cover the methods and requirements for compounding sterile preparations.
What are the major differences between USP 795 797 and 800?
Compliance with recently updated criteria for the management of hazardous medicines (HDs) and non-hazardous pharmaceuticals, which comes into effect on December 1 of this year, might provide issues for organizations who operate hospital-based pharmacies.
These requirements go into effect this year. The revised USP 797 and the newly introduced USP 800 standards can call for certain process or design adjustments. USP 797 establishes guidelines for the creation of sterile preparations, whereas USP 800 establishes requirements for the safe handling of HDs in order to limit the potential for exposure concerns.
USP 797 is concerned with the preservation of the drug’s sterility, whereas USP 800 is concerned with the protection of the employees who are exposed to the HDs. The combination of USP 797 and USP 800 creates a setting for the compounding of medications that lessens the likelihood of contamination while also working toward the goal of increasing the level of safety for medical staff, patients, and the environment. One significant change permits the compounding of low-risk pharmaceuticals with a decreased Beyond Use Date (BUD) in unclassified rooms known as Segregated Compounding Areas (SCA) for non-hazardous drugs and Containment Segregated Compounding Areas (C-SCA) for hazardous drugs.
This is a big change. A suitable ISO Class 5 Primary Engineering Control, such as a laminar air flow workbench, an A1 biosafety cabinet, or a compounding aseptic isolator, must be utilized in conjunction with these rooms at all times. Some pharmacies may find that utilizing these rooms as an alternative to ISO Class 7 Buffer Rooms with adjacent ISO Class 1 anterooms is the best course of action.
A number of states, including Massachusetts, have already issued new regulations in draft form, in addition to the federal standards established by the USP. Recent changes to the draft version of 247 CMR chapter 17 have made it such that it now closely resembles the criteria of USP 797, particularly with regard to the utilization of SCAs.
- Although the 247 CMR chapter 19 is in line with USP 800, it has not yet been revised to include the application of C-SCAs in a manner analogous to the chapter 17 change.
- As a result, facility managers in Massachusetts are faced with a dilemma: they must construct ISO 7 clean rooms with ISO 8 ante rooms for HD compounding in order to meet the federal deadline and conform to the state’s draft requirements, despite the fact that there is a possibility that these rooms will no longer be required once the draft regulation for chapter 19 of 247 CMR is finalized and promulgated, if it is amended in a manner comparable to chapter 17.
Facility managers need to take into consideration a variety of factors before moving forward with corrective actions. These factors include the level of risk posed by the drugs that are being compounded, the ability to function with a reduced Beyond Use Date, as well as the existing infrastructure and facility conditions.
- An examination of compliance concerns and a plan for corrective work can be documented after identifying them through an evaluation of current circumstances that can grow into a gap analysis.
- After compliance has been achieved, the facilities may be subject to continuous amendment requirements in order to maintain conformity.
Other factors to take into account are as follows: The facility will benefit from an examination of employing prefab panels as opposed to custom stick built panels if the design includes the building of ISO class 7 and 8 rooms. Prefab panels are more cost effective than custom stick built panels. Similar to how the USP forbids the use of refrigerators in anterooms, any future amendments to the laws might make it illegal to keep refrigerated items in CSA and S-CSA areas.
Scrub sinks may also be prohibited for use in ISO 8 ante rooms and non-classified rooms, depending on the outcome of potential changes. It is prudent for hospitals that have on-site pharmacies to begin formulating a response plan and designing solutions as soon as possible in order to be ready for whatever the future may bring.
Managing HDs is a difficult and ever-evolving process, as illustrated by the adjustments that were made to USP 797 and 800. A comprehensive analysis of the procedures and functions that are unique to each of your pharmacies is required prior to developing a long-term strategic view on floorplans, ventilation designs, and equipment configurations.
What is low risk level?
Low Risk: An unsafe state has a low probability of causing accidents, and even if it does, the accidents that it does produce inflict only minimal harm. Extremely High Risk: A dangerous state may generate repeated accidents, each of which may result in catastrophic equipment losses, personal harm, or even fatalities.
Who determines the beyond use date?
How the Date of Last Use Is Calculated – This date is determined by the pharmacy when they are preparing a compound prescription based on a variety of parameters, including but not limited to the following: What kind of medicine it is and how quickly it breaks down The appropriate quantity of the drug to take The kind of container that is currently being used The conditions in which the drug is anticipated to have been stored.
What does USP 800 stand for?
The scope of USP 800 is the description of the practice and quality standards for the handling of HDs. This includes, but is not limited to, the receipt, storage, compounding, dispensing, administration, and disposal of sterile and non-sterile products.
- In addition, this standard also includes a quality assurance section.
- This chapter applies to all members of the staff who have a potential risk of exposure to HDs.
- Personnel who are likely to be exposed include pharmacists, pharmacy technicians, nurses, physician assistants, home healthcare workers, veterinarians, and veterinary technicians.
Other personnel who may be exposed include home healthcare workers.
What does USP 795 mean?
The United States Pharmacopeial Convention (USP) specifies that “areas utilized for sterile preparations should be isolated and distinct from the nonsterile compounding area.” Now, areas for sterile preparations are protected by USP 797 and USP 800, and they require a completely distinct ISO suite. Because of this, a separate sterile compounding area is automatically set up as a result.
What is the difference between USP 795 and USP 797?
Compounding pharmacies are required to keep a condition of control, as stated in both Chapter 795 and Chapter 797 of the United States Pharmacopeia. Compounding non-sterile formulations is the emphasis of Chapter 795, whereas compounding sterile preparations is covered in Chapter 797, which includes both the techniques and regulations for compounding sterile preparations.
What are USP 797 guidelines?
Changes that have been suggested to the Open Forum Registration Multiple New Developments In order to cater to the specific requirements of individual patients, compounding pharmacies in the United States produce millions of different drugs every year.
Compounding allows patients who may not be able to use commercially accessible formulations of medication owing to dose restrictions, allergies, or uncommon conditions to have access to medication through the process of compounding. Medications that are given through injection, intravenous infusion (IV), intraocular (injection in the eye), or intrathecal (injection into the spinal column) are all examples of the types of medications that are required to be sterile (injection in the spine).
For the sake of patient safety, it is vital to get an understanding of the hazards that are inherently associated with sterile compounding and to include established guidelines. Patients who use compounded pharmaceuticals that were manufactured without the direction of standards run a substantial risk of experiencing unpleasant effects or perhaps dying as a result.