What Is Usp 800 Pharmacy?

What Is Usp 800 Pharmacy
The United States Pharmacopeial Convention (USP) General Chapter specifies rules for the safe handling of hazardous pharmaceuticals, with the goal of reducing the risk of exposure to patients, healthcare workers, and the environment. Download the USP GC for free.

Download the HazRx® Mobile App General Chemistry Infographic here. According to the National Institute for Occupational Safety and Health (NIOSH), a drug is considered to be hazardous if it displays carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs.

USP 800 What are the Risks? Pharmacy

These characteristics can be observed in humans or animals. The USP General Chapter details the standards that must be met, such as the duties of individuals who are in charge of handling hazardous pharmaceuticals; facility and engineering controls; procedures for deactivating, decontaminating, and cleaning; spill control; and recordkeeping.

Does USP 800 apply to retail pharmacy?

What Is Usp 800 Pharmacy Are you beginning to feel that the process of dispensing medication is similar to the Abbott and Costello routine “Who’s on First”? At every turn, a new regulation is being implemented; another merger of an insurer, chain, or healthcare system is taking place; some organization is auditing, inspecting, or reviewing your paperwork, files, and process; and someone new is dipping their hands into your pockets to take a little bit more of your reimbursements.

  1. In spite of all the shenanigans that are now taking place, the United States Pharmacopeia (USP) continues to be the most important subject in the pharmaceutical industry.
  2. It’s possible that some of you are thinking, “Hey, I don’t compound, so I should be fine, right?” Wrong! The United States Pharmacopeia (USP) regulates all aspects of pharmacy work, including retail pharmacies, long-term care pharmacies, compounding pharmacies, and any other institution that uses the word pharmacy in its name.

Why? because every pharmacy is capable of handling potentially harmful medications and providing them to customers. Some persons are under the illusion that they are exempt for one reason or another. Warning: the USP applies to everyone and there are no exemptions.

  • In point of fact, failing to comply can have repercussions for both the pharmacy license and the license of the pharmacist-in-charge.
  • To put the icing on the cake, a number of states have already implemented the recommendations, and the recommendations are already being enforced in those states.
  • Let’s spend some time today figuring out the who, what, when, where, and why’s of USP; what it is and where it came from; who the players and enforcers are; how to begin implementing processes to meet the guidelines; and where some huge risks are in your facility that may need to be corrected as soon as possible.

Let’s spend some time today figuring out the who, what, when, where, and why’s of USP. What: get an understanding of the implications that USP is having on many facets of pharmacy and the reasons why these effects are occurring Who are the players, and do you know who the enforcers are? Learn the actions you need to take to get started putting the recommendations into action.

What does USP in medicine mean?

Have you ever seen the initials “USP” printed on the label of a prescription medication or another type of medical product? A tradition that stretches back to the first days of our democracy — far before the United States Food and Drug Administration (FDA) was created — this is a relic of one of the nation’s earliest public health and safety precautions.

In the early years of American colonial life, medicine was performed by a wide variety of people, including apothecaries, blacksmiths, midwives, and others, each of whom offered their own unique take on commonly used remedies. Others worked, some didn’t and some were simply harmful. After the first medical school in the country was created in Philadelphia in 1765, there was an increase in the number of people who practiced medicine as a profession.

In those days, medical professionals not only manufactured and administered medication, but they also diagnosed diseases. However, despite the fact that the medical professionals had received instruction on how to correctly create medicine, there was no guarantee that the medications they crafted were made of high-quality components or that they really had any therapeutic value.

  • A national pharmacopeia and a formulary of accepted medical treatments were both deemed necessary in order to establish “some Standard amongst ourselves” by prominent national and medical figures such as Benjamin Franklin and John Morgan, who established the first medical college.
  • Benjamin Franklin was also a pioneer in the field of medicine.

When the first edition of the United States Pharmacopeia was finally printed in 1820, they had accomplished a portion of their objective. The United States Pharmacopeia is a reference that contains consistent preparations for the medications that are used the most often, along with tests that assure the quality, potency, and purity of these preparations.

As the field of pharmacy developed, more and more pharmaceutical products began to be manufactured not just by pharmacists but also by commercial suppliers. Companies like as Eli Lily started including “U.S.P.” on the labels of their products in order to let patients, medical professionals, and pharmacists know that the product had been manufactured in compliance with the quality standards outlined in the United States Pharmacopeia (USP).

These three letters provide the healthcare practitioner with a significant amount of information about the patient. They let the pharmacist or the doctor know that the medicine or product in the bottle fulfills many essential quality features that are necessary to ensure that the medicine will operate as expected.

  • These attributes are necessary to ensure that the drug will not have any adverse side effects.
  • Laboratory research serves as the foundation for the USP quality standards for the following indications.
  • Identity: Does the product match up with what it says it is? Is there an enough supply of it? This relates to its potency.

Does it lack impurities, contaminants, or any other unwelcome components? This is what we mean by “purity.” Performance – will it dissolve and disintegrate inside the body, allowing for the body to absorb the active ingredient? The Pure Food and Drug Act was officially enacted into law by President Theodore Roosevelt in the year 1906.

The law defined a drug as “all medicines and preparations recognized in the United States Pharmacopeia (USP) or National Formulary (NF),” and it defined adulterated drugs as those referenced in the USP and NF but differing from “the standard of strength, quality, or purity” specified in the two compendia.

This allowed the law to elevate the public health role of the United States Pharmacopeia. It became increasingly common practice to affix the letters “U.S.P.” or “USP.” on the labels of pharmaceutical products. The Food, Drug, and Cosmetic Act of 1938 reaffirmed the function of the pharmacopeia and expanded its duty to include USP requirements for labeling and packaging.

  1. This act was passed in response to concerns over the safety of food, drugs, and cosmetics.
  2. Even though the words “USP” aren’t printed anywhere on the packaging, pharmaceutical products that are distributed commercially in the United States must comply with current USP criteria.
  3. As a direct consequence of this, a number of manufacturers have abandoned the practice, but the term “USP” may still be seen on the labels of a significant number of products.

Take a look inside your medicine chest; there’s a good possibility that you have a widely used antiseptic for first aid that has the label “Hydrogen Peroxide Topical Solution 3% USP” or anything quite close to that. These three letters on the label indicate that the product was manufactured in accordance with USP standards.

  • Dietary supplements, on the other hand, present a rather unique circumstance.
  • The Dietary Supplement Health and Education Act was enacted in 1994 with the goals of broadening Americans’ access to natural health products and establishing a distinct regulatory framework.
  • Both of these goals were accomplished.

In contrast to the pharmaceutical industry, the supplement industry is not required to undertake clinical tests on its products in order to demonstrate that they are both effective and safe before releasing them on the market. In the same way as it does with pharmaceuticals, DSHEA mandates that businesses adhere to good manufacturing procedures and acknowledges the USP–NF as a “approved compendia.” On the other hand, in contrast to medicines, compliance with USP requirements for dietary supplements is completely VOLUNTARY.

  • Dietary supplement manufacturers have the option of following USP standards and including the letters “USP” on the labels of their products to indicate to pharmacists, medical professionals, and consumers that their products conform to USP standards.
  • Some manufacturers choose to follow this option, particularly for letter vitamin and mineral products such as vitamin C, calcium, and iron.

Another option is for makers of dietary supplements to develop and adhere to their very own internal, private standards. The DSHEA, due to the way it was written, unfortunately had several unforeseen repercussions. The benefits of being able to recognize a premium product by checking for “USP” on the label have been overshadowed by potential regulatory enforcement implications, which serve as a discouragement.

  1. According to DSHEA, a dietary supplement product may be considered to have committed the offense of misbranding if it is advertised as adhering to “USP” requirements but does not in fact adhere to such specifications.
  2. This implies that dietary supplements are required to adhere to USP standards IF the initials “USP” appear anywhere on the product’s label.

Even if they adhere to USP standards, many manufacturers of dietary supplements opt not to use the abbreviation “USP” on their product labels since doing so would make them more susceptible to regulatory action from the FDA. Because of this, it is difficult for pharmacists, healthcare practitioners, and customers alike to determine whether or not a particular dietary supplement product is manufactured in accordance with the quality criteria established by the USP.

  • The USP Dietary Supplement Verification Program (DSVP) was developed by the organization in order to fill this void and to continue to provide a means through which quality may be made public.
  • Participation in the DSVP is completely optional for manufacturers.
  • The unique USP Verified Mark is awarded to manufacturers that participate in the program and who successfully fulfill the stringent standards established by USP.

The USP Verified Mark on the label of a dietary supplement ensures that “what’s on the label is in the bottle,” providing consumers and healthcare professionals with the confidence they need to make an informed decision about the supplements they take.

What are the three types of hazardous drugs?

Publication Number DHHS (NIOSH) Publication No. Antineoplastic medications, non-antineoplastic hazardous pharmaceuticals, and drugs having reproductive effects will all be included on the updated format for the 2014 list, which was altered to cover these three categories of potentially hazardous substances.

Who is enforcing USP 800?

Introduction When many people who provide long-term care first hear about the USP General Chapter on Hazardous Drugs–Handling in Healthcare Settings (also known as “USP 800”), they naturally confuse it with the final EPA hazardous pharmaceuticals rule (also known as “EPA Rule”), which started being enforced in August of 2019.

  1. The rules of the EPA Rule concern hazardous medications after they are no longer employed for their original purpose and have therefore become waste, despite the fact that there are specific situations in which the two overlap.
  2. USP 800, on the other hand, addresses hazardous medicines (“HDs”) throughout the entirety of their post-manufacturing lifespan, beginning with receipt and storage and continuing all the way through disposal.

As a consequence of this, it is quite likely that the operations of pharmacies and other healthcare facilities will be significantly impacted by USP 800. The United States Pharmacopeial Convention produced USP 800 in 2016 as a set of practice and quality standards for dealing with HDs.

  1. USP 800 is not a regulation; rather, it is a collection of such criteria (“USP”).
  2. It is included in the compendium of standards that the USP has compiled for the compounding of pharmaceuticals.
  3. On December 1, 2019, USP will become an official organization.
  4. However, revisions to other chapters in the compendium of compounding standards are currently being appealed, and USP has stated that until such time as those appeals are resolved, USP 800 will be “informational and not compendially applicable.” USP will become an official organization on December 1, 2019.

At the federal level, USP 800 will largely be enforced by the Occupational Safety and Health Administration (“OSHA,” for short), while at the state level, enforcement will be handled by state boards of pharmacy. In the long run, it’s possible that the Food and Drug Administration (“FDA”) of the United States will also have some level of regulatory power.

Compliance According to USP, the provider is required to nominate a person who is “qualified and trained” to be accountable for the following: Developing and putting into effect relevant rules and procedures; monitoring compliance; ensuring that workers have the necessary skills; and ensuring that storage and compounding areas have environmental control (as applicable).

The hazards connected with HDs, from the perspective of both safety and compliance, must be “thoroughly understood” by the authorized person, since this is a requirement that is emphasized by USP. In addition to this, the authorized person is obligated to supervise any testing or sampling that takes place at the facility.

  • The USP 800 does not specify the specific credentials that the designated person must possess; nonetheless, this person should have an awareness of the hazards that are provided by HDs as well as the engineering controls and work practices that are meant to reduce those risks.
  • If there is a pharmacy located on the premises of the facility, then the pharmacist would be the most qualified candidate for this role.

In the event that there is not an on-site pharmacist, it is probable that the duty for compliance will be delegated to a registered nurse; nevertheless, further training may be required. It is the responsibility of the facility staff who handle hazardous materials (HDs) to understand the fundamental practices and precautions involved in handling HDs, as well as to continually evaluate these practices and precautions in order to prevent harm to residents, minimize exposure to other facility staff, and minimize contamination.

  1. As a result, USP 800 mandates the completion of rigorous staff training before personnel are allowed to independently handle HDs.
  2. In addition, the staff’s level of proficiency needs to be shown, documented, and reevaluated at least once per year.
  3. Under the heading “TRAINING,” which may be found further down on this page, we will go through these training needs in further detail.

Risk Assessment Due to the fact that USP 800 is applicable in a wide variety of health care settings and is, as a result, quite thorough, not all of the standards will be relevant in every single context. As a consequence of this, it will be absolutely necessary for those who offer long-term care to familiarize themselves with USP 800 and then conduct a risk assessment that takes into account the following: Identifying any HDs that may be present in the establishment.

Antineoplastic, non-antineoplastic, or simply associated with reproductive risk are the types of HD (see IDENTIFYING HAZARDOUS DRUGS below for descriptions). Dosage form – The degree of danger associated with various dosage forms, such as pills, capsules, or liquids, varies based on the amount of manipulation that occurs before the medication is administered.

Packaging: Certain packaging options (such as single-dose packs, vials, and bottles), in comparison to others, entail significantly higher hazards of exposure to the product’s contents. Performing an investigation on the flow of HDs throughout a facility.

  • Preparation for Receipt Storage includes actions such as compounding or other manipulations essential for administration, such as crushing, splitting, or other similar procedures.
  • Disposal determining which employees would have direct or indirect interaction with HDs as a result of their work responsibilities.

Pharmacists Aids to the nursing staff Therapists Housekeeping and janitorial crew Others the process of identifying and measuring the risk of exposure from HDs at each stage of their movement through the facility where they are housed. After the risk assessment has been finished, an evaluation of the effectiveness of the controls and containment methods already in place, as well as the policies and procedures, for preventing or minimizing exposure to HDs in light of the requirements of USP 800 should be carried out in order to determine whether or not additional precautions will need to be taken.

  • Compounding and other manipulations of HDs may need to comply with certain engineering controls in some cases, however this will depend on the type of the operations that are being carried out in the facility.
  • The Recognizance of Dangerous Drugs For the purposes of USP 800, high doses are defined as those mentioned in Publication No.2016-161 from the National Institute for Occupational Safety and Health (NIOSH).

The National Institute for Occupational Safety and Health (NIOSH) uses the following factors to assess if a medicine is hazardous: Carcinogenicity refers to the propensity of a substance to cause cancer. Teratogenicity refers to the effect that some medications have on the development of an embryo or fetus.

  • Toxic effects on reproduction can be caused by substances that impair sexual function and/or fertility.
  • Genotoxic medications are those that have a deleterious effect on the genetic material of a cell.
  • Substances that, even in small concentrations, can be harmful to organs.
  • drugs that are structurally or toxicologically similar to already existing harmful drugs (HDs).
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As a result, the National Institute for Occupational Safety and Health has classified dangerous medications into the following three categories: Group 1: antineoplastic medications. These are drugs that work to prevent, stop, or halt the formation of tumors; for example, chemotherapeutic treatments such as tamoxifen and others.

Group 2: antimetabolites. These are pharmaceuticals that act to prevent, inhibit, or halt the development of tumors. Non-antineoplastic medications that fulfill one or more of the NIOSH criteria for a hazardous drug are included in Group 2 of the NIOSH classification system. Certain estrogen and progesterone medicines, in addition to cyclosporine and other medications, are some examples.

Group 3 includes substances that are particularly harmful to the reproductive health of men and women who are attempting to conceive, as well as pregnant or nursing women, and those who are actively trying to conceive. Clonazepam, fluconazole, testosterone, and warfarin are some examples of drugs that fall within this category.

Nursing homes and other long-term care facilities in which HDs are administered or encountered by other means are required to use the NIOSH lists and criteria to generate their own facility-specific list of HDs as part of their compliance efforts with respect to the OSHA Hazard Communication Standard.

This is to ensure that the facility is in full compliance with the OSHA Hazard Communication Standard. This list is required to be reviewed and brought up to date at least once per year in accordance with USP 800. The HazRxTM Mobile App was created by USP in order to make the process of identifying HDs more straightforward.

  1. The software not only identifies HDs, but it also gives information on safe handling methods for each of the HDs that are contained in its database.
  2. Different kinds of exposure Examples of inadvertent occupational exposure to HDs are included in USP 800.
  3. These examples include cutaneous and mucosal absorption, as well as inhalation, injection, and ingestion during a variety of tasks.

Long-term care facilities may not offer all of the possible avenues of exposure; this is especially true in the event that the facility does not have its own pharmacy on-site. However, even for long-term care institutions that make use of pharmacies located in the surrounding community, there are significant dangers.

When drugs are received, it is common to see HD remains on the medication containers, individual dose units, exterior containers, work surfaces, and floors. Tablets and capsules are counted and repackaged as part of the dispensing process, which takes place at long-term care institutions that have their own pharmacies on-site.

Compounding and Other Manipulations – Compounding, which is the process of combining, mixing, or altering ingredients to create a medication that is tailored to the needs of an individual patient and includes the combination of two or more drugs, presents significant opportunities for exposure to HDs.

Even while it is highly rare that medications will be compounded in a long-term care facility, particularly if the institution makes use of an external long-term care pharmacy, there are various manipulations of HDs that may result in occupational exposure. These include: Examples include: Tablets may be broken up into smaller pieces or split, and capsules can be opened.

The process of either producing or reconstituting powdered HDs. The process of forcing air or HDs out of syringes. Administration The production of aerosols during the administration of HDs by many routes, including injection, irrigation, oral, inhalation, or topical application of the drug.

Getting an intravenous administration set ready to use. Handling body fluids or garments, dressings, linens, or other things that have been contaminated with such fluids is an activity that falls under the category of patient care activities. Spills are defined as the creation, management, and disposal activities associated with spills.

Moving hard disks around within the facility is what we mean by “transport.” Waste: The process of collecting and disposing of hazardous waste and waste that contains traces of contamination. Controls for the Facilities and the Engineering The United States Pharmacopeia (USP) stipulates that handling of HDs must be done in such a way that “promotes patient safety, worker safety, and environmental protection.” According to USP 800, specific facilities and engineering controls, including as warning signs and limited access areas, as well as substantial and expensive containment chambers for compounding processes, are required to be put into place.

This is done in order to achieve the aforementioned goal. Designated locations for the reception and unpacking of HDs, as well as storage and compounding of HDs, must be located in a separate building from staff break rooms and refreshment areas that are accessible to residents, visitors, and employees.

Despite the fact that the majority of the below requirements are better suited to the environment of a pharmacy than the typical long-term care facility that obtains medications from a long-term care pharmacy, they are instructive in terms of the nature and extent of the precautions that are required to minimize exposure to HDs.

  • Receipt – Antineoplastic HDs and HD Active Pharmaceutical Ingredients (“APIs”) are required to be taken from exterior shipping containers in an area that has neutral/normal or negative pressure as comparison to the pressure in the surrounding regions.
  • Storage: Hard drives need to be stored in a way that prevents them from breaking or spilling their contents, but they should never be put on the floor.

In most cases, HDs and non-hazardous medications are able to be kept together. However, antineoplastic HDs that need manipulation other than counting or packing of final dose forms need to be maintained separately in a chamber with negative pressure and external ventilation.

  • Antineoplastic HDs that need to be refrigerated must be kept in a room with negative pressure and a refrigerator that is only used for that purpose.
  • Compounding is a process that requires highly specialized and expensive engineering controls.
  • Sterile and nonsterile compounding operations also require engineering controls.

These include the containment secondary engineering control (also known as the “C-SEC”), which is the room in which the containment primary engineering control (also known as the “C-PEC”) is located; supplemental engineering controls; and the containment primary engineering control (also known as the “C-PEC”), which is an externally-vented device designed to minimize worker and environmental exposure to HDs.

  1. Controlling the Quality of the Environment To ensure that there is no contamination escaping from a contained area, USP 800 recommends conducting wipe testing for HD surface residue at least once every six (6) months.
  2. It is recommended that this sort of sample be carried out in the patient administrative sections of long-term care institutions that do not include a pharmacy.

Wipe sampling other possible avenues for contamination, such as medication carts used to transport HDs for administration to residents, would add another layer of confidence that HD residue is not coming into contact with staff handling the carts. Even though this is not addressed in USP 800, it would add another layer of confidence that HD residue is not coming into contact with staff.

  1. According to USP, there are currently no guidelines in place that define permissible levels of HD surface contamination.
  2. Therefore, if any quantifiable contamination is found, the employee at the plant who is appointed to oversee compliance needs to determine the source of the contamination, document it, and then put a stop to it.

After that, the area needs to be cleaned in accordance with the USP 800 procedures for deactivation, decontamination, and cleaning (for more information, see DEACTIVATION, DECONTAMINATION, AND CLEANING below), in addition to the measures that need to be taken to address the underlying cause of the contamination.

  1. Personal Protective Equipment It is very necessary to use personal protective equipment (also known as “PPE”) in order to cut down on exposure to HD residues and aerosols.
  2. According to USP 800, providers are required to create policies and procedures for the use of personal protective equipment (PPE) that are suitable for the activity and the level of risk of exposure.

After being worn, personal protective equipment (PPE) should be handled as if it were tainted with at least a trace amount of hazardous dusts (HDs). The disposal of disposable personal protective equipment (PPE) requires that it be done in compliance with the requirements of any applicable laws.

  • Decontamination and cleaning are required for reusable protective equipment.
  • Gloves Two pairs of the so-called “chemotherapy gloves,” which are specialized medical gloves made from nitrile or natural rubber latex and are used for handling chemotherapy drugs, have to be worn in order to administer injectable antineoplastic HDs.

These gloves are designed specifically for the handling of chemotherapy drugs. It is recommended by USP, however, that protective gloves be used when handling any and all HDs. Powder-free chemotherapy gloves are necessary to eliminate the risk of the powder absorbing HDs and spreading them throughout the working environment.

To properly administer injectable antineoplastic HDs, gowns are have to be worn at all times. They must be chosen according to the types of HDs that will be handled and meet the following requirements: (a) they must be disposable; (b) they must resist the permeability of HDs; (c) they must have long sleeves; (d) the cuffs must be closed, elasticized, or knit; and (d) they must close in the back.

The gowns need to be changed in accordance with the advice provided by the manufacturers about permeability. In the event that this information is not readily available, they should be replaced every two to three hours or promptly after a spill or spray of HDs.

  1. Because doing so might potentially spread contamination to other parts of the facility, they are only allowed to be worn inside the immediate confines of the workspace in which they are being utilized.
  2. Covers for the head, hair, shoes, and sleeves may be necessary pieces of personal protective equipment for staff members, depending on the activity and the potential for HD contamination.

Shoe coverings, in particular, should not be worn outside of the local area in which they are being utilized in order to avoid spreading contamination to other parts of the facility. This rule applies to gowns as well. Eye and Facial Protection Whenever there is a potential for HDs to cause spills or splashes, it is imperative that eye and face protection be used.

Goggles, full-face shields, and full-facepiece respirators are all examples of protective equipment that offer sufficient coverage. Eye glasses and safety glasses are not an adequate method of protection against contamination caused by splashing. The United States Pharmacopeia (USP) states that a fit-tested NIOSH-certified N95 respirator is sufficient for protecting against the inhalation of airborne particles for the majority of activities that require respiratory protection; however, these respirators do not provide sufficient protection against the inhalation of gases and vapors.

Again, the amount of protection that is necessary will be determined by the danger that is posed by the activities that are being carried out, the HDs that are involved, and the form that they take. When HDs are taken orally in the form of tablets or capsules, for instance, the danger of inhalation is significantly reduced.

If the pills have to be crushed or the capsules have to be opened, then the possibility of inhaling airborne particles is increased. When working in conditions where there is a potential for respiratory exposure, it is important to wear the proper form of respirator, whether it be a powered air-purifying respirator or a chemical cartridge-type full-facepiece respirator.

Hazard Communication Program OSHA’s Hazard Communication Standard seeks to ensure chemical safety in the workplace by requiring that employers develop a written hazard communication program for making information about the identities and hazards presented by chemicals available and understandable to workers through labeling and the use of Safety Data Sheets (“SDSs”), and training.

The Hazard Communication Standard must be considered in long-term care facilities and other health care settings where HDs are present. As far as USP 800 is concerned, the USP stipulates that the hazard communication program must have the following components in order to be considered compliant: Plan in writing that outlines the process by which the standard will be implemented; Containers containing hazardous compounds are required to be labeled, tagged, or otherwise marked with the material’s name as well as any applicable danger warnings; SDSs for any potentially dangerous substances that are utilized in the workplace; SDSs are within easy reach of people during each shift as well as while they are working in their respective regions; Before workers are first assigned to work with a hazardous chemical, they get information and training on how to operate safely with the chemical.

and A signed statement by personnel with reproductive capacity indicating that they are aware of the dangers associated with handling HDs. Training Before employees can manage HDs on their own, they are need to undergo training that is tailored to their specific work tasks.

  • The efficacy of training for HD handling abilities must be shown and must be evaluated at least every 12 months.
  • In the event that a new HD or new piece of equipment is going to be introduced that calls for new or major modifications in the HD policies and procedures of the provider, then the staff will need to undergo training prior to the change.

The following subjects absolutely need to be included in the training program: A rundown of the HDs and the hazards that are connected with them on the provider’s list; Examination of the provider’s policies and operating procedures pertaining to the management of HDs; Use of appropriate personal protective equipment; Use of appropriate engineering controls; Management of any spills that may have occurred and the correct disposal of any hazardous waste or objects that may have been contaminated with hazardous waste Receiving USP 800 addresses receiving practices and demands that the provider develop rules and procedures for safe handling and responding to damaged shipping containers.

Although it is aimed toward the pharmaceutical setting, USP 800 addresses receiving practices. Every HD that is delivered to a facility is required to undergo a visual inspection to look for any evidence of damage or breakage. Any damaged packages need to be treated in the same manner as if they contained a spill.

Labeling, Packaging, Transport and Disposal The provider is required to develop policies and procedures for the labeling, packaging, transport, and disposal of HDs. These policies and procedures must address the prevention of accidental exposures or spills, as well as the training of staff regarding how to respond to exposures, and the use of a spill kit.

If the HDs are considered to be hazardous waste in accordance with the EPA Rule, then the hazardous waste rule must also be adhered to. Labeling: To the extent that the provider recognizes HDs that require particular handling considerations, such HDs are required to be properly labeled at all times during their carriage inside the facility.

This requirement applies even if the provider does not identify such HDs. Packaging – The necessity that there be appropriate packaging is more relevant in the context of pharmacy operations. It stipulates that the containers and materials used for packing must be selected in a way that will protect the product’s sterility, stability, and physical integrity (if needed).

Transport HDs have to be carried in containers that reduce the chances of their breaking or leaking as much as possible. If they are no longer being used for their original purpose and are to be thrown as waste, they must be labeled, stored, and handled in compliance with current legislation, including the EPA Rule.

If they do not meet these requirements, they are considered to be garbage and must be destroyed. Disposal USP 800 mandates that all people who execute normal custodial waste collection and cleaning operations have received training in the proper methods to prevent HD contamination.

  • This training must take place before the staff can perform their duties.
  • In addition, HD waste (including personal protective equipment that is contaminated with traces of other substances), must conform with all laws and regulations that are relevant, including the EPA Rule.
  • Dispensing and Administering Hyperbaric Oxygen Therapy In establishments that have a pharmacy on-site, the pharmacist is responsible for performing a visual inspection of all HD containers prior to dispensing hyperbaric oxygen therapy in order to look for signs of possible hyperbaric oxygen therapy exposure, such as leakage or dust.

HDs that do not need to be manipulated in any way can be dispensed without the need for any additional requirements, in addition to those that are needed by the manufacturer. When dispensing HDs, specialized equipment should be utilized, and after each usage, the equipment in question should be thoroughly cleaned and put away in an appropriate manner.

For the safe administration of HDs, the USP 800 mandates the use of “protective medical devices and techniques,” such as needleless systems, spiking or priming of IV tubing with a non-HD solution in a C-PEC, and, of particular significance to those who provide long-term care, crushing tablets in a plastic pouch in order to contain dust or particles.

However, the United States Pharmacopeia (USP) advises that medical professionals should avoid manipulating HDs as much as possible, such as by crushing tablets or opening capsules. The USP also states that liquid formulations should be preferred if solid oral dosage forms cannot be used for some reason.

When such manipulation is necessary, personal protective equipment (PPE) must be used. In addition, the USP specifies that the administration of antineoplastic HDs must be performed via a device known as a “closed-system drug transfer device” (CSTD). CSTDs are a type of additional engineering control that can be implemented.

Cleaning, Deactivating, and Decontaminating an Area It is necessary to deactivate, clean, and disinfect any areas that are used for the handling of HDs, as well as any equipment and devices that are not disposable, such as respirators. The procedure of turning a substance inert or inactive is referred to as the deactivation process.

  1. Cleaning gets rid of both organic and inorganic debris, whereas decontamination gets rid of any HD residue that may be present.
  2. The providers are required to create documented rules and procedures for the implementation of these practices.
  3. In the procedures for cleaning, the cleaning agents that are going to be used, the dilution levels (if any) of those cleaning agents, the frequency of cleaning, and the documentation requirements need to be specified.
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Personnel who are responsible for deactivation, decontamination, and cleaning are required to wear personal protective equipment (PPE) that is resistant to the cleaning agents that are used (as well as the HD residues). This PPE must include two pairs of chemotherapy gloves and impermeable disposable gowns.

  • Eye protection and face shields are essential if there is a risk of splashing, and depending on the circumstances, breathing protection may also be necessary.
  • The deactivation, decontamination, and cleaning chemicals that are employed must be suitable for the type(s) of HD contaminant(s), the location(s), and the surface materials.

Instead of using a spray bottle, it is recommended that the agents be administered with moist wipes. In order to comply with the requirements set forth by the EPA, the wipes need to be thrown away. Containment of the Leak and Cleaning Up Personnel who have been educated in spill control and the proper use of personal protective equipment (PPE) are required to quickly contain spills and clean them up.

  • During the entirety of the HD handling process, such people is required to be present at all times.
  • Every location that regularly deals with hazardous materials (HDs) has to have a spill kit readily available.
  • A spill kit is a collection of different products that may be utilized in the case of a spill.

These kits often include personal protective equipment (PPE), sorbents (such as absorbent pads or towels), a manual, a disposal bag, and several other things. Sorbents are designed to swiftly absorb and store a range of liquids. In order to comply with EPA standards, any items that need to be cleaned up must be categorized as hazardous waste.

  • Staff members who have had direct skin or eye contact with hazardous materials (HDs) or who are possibly exposed as a result of the spill or cleaning need to be examined as soon as possible.
  • Emergency workers are required to assess residents, guests, and any other individuals who are not employees of the facility.

The providers are required to have policies and processes in place to not only avoid spills but also document and regulate how they are cleaned up if they occur. The following concerns need to be addressed by such policies and procedures: The magnitude and breadth of the spill; Who is responsible for managing the spill; The type of personal protective equipment (PPE) necessary, as well as how it should be used; The location, contents, and capacity of any spill kits.

  1. Documentation, Operating Policies, and Procedures As has been mentioned throughout this resource, the United States Pharmacopeia (USP) mandates that service providers devise and put into action policies and procedures to ensure the safe handling of hazardous drugs (HDs).
  2. The designated compliance person is responsible for conducting a review of these policies and procedures at least once per year.

Documentation is required for such a review. Following is a list of policies and processes that are recommended by USP 800: Hazard communication program; occupational safety program; designating hazardous materials locations; receiving, storing, and compounding hazardous materials (if appropriate); utilizing and maintaining engineering controls; Hygiene of the hands and use of appropriate personal protective equipment (PPE) in accordance with the activity being carried out; deactivation, decontamination, and cleaning; dispensing (where applicable); Transportation and administration, as well as environmental and medical monitoring and control, spill containment, and waste disposal.

  • Medical Surveillance According to USP, a medical monitoring program for workers who regularly handle hazardous drugs (HDs) as part of their jobs is an essential component of any exposure management program that should be implemented.
  • In the process of medical surveillance, symptom complaints, physical findings, and laboratory results are evaluated and documented in order to search for any adverse health consequences that may be attributed to HD exposure.

As such, it is a method for early detection, it creates data on trends, and it offers a method for evaluating the efficacy of engineering controls, personal protective equipment (PPE), work practices, and training. The following should be included as components of a medical monitoring program: A methodical strategy for locating employees who may be at risk of contracting HDs as a result of the nature of their job responsibilities; utilizing the services of a medical provider to carry out the medical surveillance; Establishment of a baseline evaluation of each person’s current health state as well as their medical history, including the following: The past of medicine (including reproductive history) Work history to determine whether or whether there has been past exposure to HDs An examination of the body Examinations in the laboratory In accordance with the standards set out by OSHA, medical records of surveillance should be maintained; Prospective monitoring of the health of workers by the use of periodic evaluations; monitoring of the data to identify any failures in prevention that might lead to adverse health impacts; the creation of a strategy for the long-term monitoring of people whose health has deteriorated in a way that is consistent with toxicity, or who have had an acute exposure to HDs (for further information, see below); When an enrolled individual quits their job with the provider, they are required to complete an exit examination.

In the event that a member of staff suffers changes to their health caused by exposure to an exposure event or an acute exposure event, the following actions should be taken as part of any follow-up plan: Carry out a post-exposure physical assessment that takes into account the nature of the exposure that had place.

This examination need to have primary emphasis not just on the damaged region but also on other organ systems that are typically implicated. On the basis of the results of the physical examination, treatment and laboratory testing will be carried out; Ensure that each individual who has been exposed receives a discreet notification of any harmful effects to their health; Ensure that the afflicted individual and health care professionals may communicate with one another in a secure manner and in both directions; Make a suggestion for a different type of task or a temporary transfer; Evaluate the effectiveness of the controls in comparison to the required criteria.

  1. Ensure that all engineering controls are operating correctly, and document your findings; Check to see if the staff member cooperated with the established policies and procedures, and document your findings.
  2. Conceive of and record in detail a strategy to reduce the risk of further exposure; and To demonstrate that the follow-up strategy is working well, provide a follow-up medical survey and document the results of the survey.

Conclusion The presence (or absence) of an in-house pharmacy will be the decisive factor for long-term care providers, both in terms of the form of their compliance requirements and the degree of those duties, in accordance with USP 800. Because of the greater quantities of medications that are being brought into the facility, establishments that already have a pharmacy on the premises will be held to stricter standards when it comes to the reception, storage, transportation, and disposal of controlled substances.

  • Compounding procedures performed by an in-house pharmacy may need the implementation of extensive and expensive engineering controls, as well as the usage of more advanced personal protective equipment (PPE).
  • But even for facilities that do not have an in-house pharmacy, the challenge of compliance could prove to be daunting for the simple reason that facilities that do not have an in-house pharmacy do not have a pharmacist on staff who is familiar with HDs and likely has experience dealing with them.

This makes the compliance challenge more difficult. As a consequence of this, establishments will be required to make arrangements for more advanced training for a member of the clinical staff before that member of the staff may take on supervision responsibilities for ensuring compliance with USP 800.

However, despite the fact that the requirements of USP 800 may appear to be overwhelming, a robust and fully implemented compliance program that focuses on risk assessment, tailored engineering controls and work practices, exposure prevention, environmental monitoring, training, and medical surveillance may ultimately pay dividends to providers as a risk mitigation tool by better protecting both residents and staff from the possibility of adverse health effects brought on by exposure to HDs.

However, the efficiency of the policies, processes, and training protocols created as part of the program, as well as the provider’s commitment to constant review and development of the program, are essential components to the success of any compliance program.

  1. A program is bound to fail if it is not thought of with the commitment of the organization and carried out completely with the buy-in of the workforce.
  2. In this scenario, the failure to implement the interventions and systems required by USP 800 would put residents and staff at risk of experiencing potential adverse health effects from HDs.

As a result, the likelihood that the provider will be held liable for any such adverse health effects would increase.

Why is adherence to USP 800 important?

According to the Centers for Disease Control and Prevention, there are approximately 8 million healthcare workers who are exposed to hazardous drugs on an annual basis. The USP Hazardous Drug – Handling in Healthcare Settings standard, which was introduced in 2016, aims to address the alarming statistics related to hazardous drug exposure.

  • Even though they are aware of the critical situation, many pharmacy directors lack the resources necessary to assure continuing, sustainable compliance.
  • The impending implementation of USP presents hospitals with a wide variety of obstacles, and it may be tough to find one’s way through the maze of complications.

The following are some of the most important takeaways from the webinar that was conducted by Simplifi 797 and was titled “Preparing for Enforcement: USP Readiness Checklist.” Because there is evidence that being exposed to medicine can be dangerous, developing a comprehensive program to ensure the safety of hazardous drugs is essential.

What type of compounding does USP 800 apply to?

The USP is developed in conjunction with the USP General Chapters for non-sterile compounding and the USP for sterile compounding. When dealing with potentially dangerous medications in a medical context, the objective of this chapter is to lay out certain guidelines and procedures that may be followed to ensure the safety of workers, patients, and the surrounding environment.

When did USP 800 become official?

Appeals to revisions of two compounding standards were granted by an Appeals Panel of the United States Pharmacopeial Convention (“USP”) on March 12, 2020. These standards are General Chapter Pharmaceutical Compounding – Nonsterile Preparation (“Chapter 795”) and General Chapter Pharmaceutical Compounding – Sterile Preparations (“Chapter 797”).

  1. At the same time, an appeal to General Chapter Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging was turned down by the Appeals Panel.
  2. The appeals that were lodged against the changes of Chapters 795 and 797 have been sent back to the Compounding Expert Committee of the USP with a request for “additional engagement” on the problems that were brought up in the appeals.

Because of the rulings made by the Appeals Panel, the official versions of Chapter 795, which was most recently updated in 2014, and Chapter 797, which was most recently updated in 2008, will continue to be in force. The appeals were a direct consequence of the amendments that were made to Chapters 795 and 797, which were then made public on June 1, 2019.

It is important to note that the status of Chapters 795 and 797 is crucial because of the influence that it has on the application of USP General Chapter (“Chapter 800”), which controls the proper and safe handling of potentially dangerous medications (“HDs”). Chapter 800 will continue to be “informational and not compendially relevant” since the existing official versions of Chapters 795 and 797 will continue to be in effect until the status of the 2019 modifications is fully settled.

Only when it is referenced in (a) a USP monograph, (b) another general chapter numbered below 1000, or (c) USP General Notices does a general chapter with a number lower than 1000 become compendially applicable and, as a result, a required standard. This is because the framework for USP’s standards states that this is the only way for a general chapter to become compendially applicable.

  1. In the instance of Chapter 800, it is mentioned in the upcoming 2019 revisions of both Chapters 795 and 797; nevertheless, it is not included in the currently official editions of both chapters, nor is it mentioned in a monograph or in the General Notices.
  2. As a result, Chapter 800 will continue to serve an informational purpose, and it will not be compendially relevant until the revisions to Chapters 795 and 797 are completely settled.

So, what exactly does this imply for those who work in health care? Even while the informational standing of Chapter 800 is crystal obvious for the near future, it is still unclear how federal and state authorities will react to the new facts. The United States Pharmacopeia has made it abundantly clear that state agencies (such as State Boards of Pharmacy), other regulators (such as the Occupational Safety and Health Administration), and oversight organizations (such as The Joint Commission) are free to make their own judgments regarding the applicability and enforceability of Chapter 800 for organizations that fall under their purview.

USP has also said that it continues to engage regulators, certification bodies, and stakeholders with the compendial status of Chapter 800, and that it provides information to these groups. Because the federal government and state governments are now trying to deal to the COVID-19 problem, it is safe to expect that efforts by regulators and oversight groups to execute any enforcement of Chapter 800 will be postponed.

This is because of the current state of affairs. Any such delay provides health care providers with the opportunity and time to evaluate how the provisions of Chapter 800 influence their operations and to implement any adjustments to their physical plant or operational procedures that are mandated by the results of that evaluation.

Regarding the 800th Chapter The management of HDs is governed by Chapter 800, which is not a regulation but rather a collection of practice and quality requirements that are in place from the time an HD is received at a health care institution until it is discarded (and beyond, when medical surveillance is factored in).

Chapter 800 became official on December 1, 2019; however, as was mentioned above, it will continue to be informational and will not be compendially applicable until the revisions to Chapters 795 and 797 are fully resolved. This is because Chapter 800 is dependent on Chapter 795 and Chapter 797 for its applicability.

The following topics are addressed by the regulations included in Chapter 800: Identification of Hazardous Disposal Items Types of Exposure Responsibilities of Staff Handling Hazardous Disposal Items Facilities and Engineering Controls Controlling the Quality of the Environment Personal Protective Equipment Staffing and training for the Hazard Communication Program and receiving Labeling, Packaging, Transport, and Disposal Dispensing The Complete Dosage Forms Compounding and administering HDs Deactivating, decontaminating, cleaning, and disinfecting the environment Compounding and administering HDs Spill control Guidelines and Operating Procedures Medical Surveillance Due to the fact that Chapter 800 is relevant in a number of different health care settings and is, as a result, quite comprehensive, not every standard will be applicable in every setting to the same degree.

As a consequence of this, it will be absolutely necessary for health care providers to become familiar with Chapter 800, and then to conduct a risk assessment that takes into account the HDs that are administered within the facility, the movement of HDs throughout the facility, staff members who may come into contact with HDs, and the quantification of the risk for exposure to HDs for each activity that is carried out within the facility.

After the risk assessment has been finished, an evaluation of the efficiency of the controls and containment mechanisms that are already in place has to be carried out so that it can be determined whether or not extra precautions need to be taken. Compounding may necessitate the use of specialized engineering controls; however, this is contingent on the kind of the operations that are being carried out in the facility.

In addition, there will be a requirement for the development of policies, processes, and training protocols with the intention of preventing or reducing exposure to HDs. In accordance with the requirements of USP Chapter 800, a person who is both qualified and trained is required to be designated as the individual in charge of formulating and carrying out appropriate procedures, supervising compliance, ensuring the competence of personnel, and ensuring environmental control in storage and compounding areas (as applicable).

The hazards connected with HDs, from the perspective of both safety and compliance, must be “thoroughly understood” by the authorized person, since this is a requirement that is emphasized by USP. In addition to this, the authorized person is obligated to supervise any testing or sampling that takes place at the facility.

It is the responsibility of the facility staff that handles HDs to understand the fundamental practices and precautions, as well as to continuously evaluate them, in order to prevent harm to individuals being served by the provider, minimize exposure to staff, and minimize environmental contamination from HDs.

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Who regulates USP?

Compounding Standards Recognized by States in Accordance with USP The supervision of pharmacists at work is under the purview of the governing authorities of each state’s pharmacy industry. Nearly every state has some form of legislation, regulation, or policy pertaining specifically to compounding.

  1. According to the results of the 2016 NABP Survey of Pharmacy Law, at least 87 percent of boards of pharmacy either demand complete compliance with the USP General Chapter or include some aspect of the USP General Chapter into the legislation that govern their states in some form.
  2. The majority of the boards that do not already have such standards are either in the process of formulating regulations to address them or view them as a recommended practice.

The United States Pharmacopeia (USP) General Chapters and have been incorporated into the NABP Model Pharmacy Act and Model Regulations that were published in August 2016. These documents supply boards of pharmacy with model language that may be utilized for establishing state legislation or board rules.

What is the difference between USP 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. What Is Usp 800 Pharmacy 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.

  1. 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.
  2. 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. What Is Usp 800 Pharmacy 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.

  1. 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.
  2. Prefab panels are more cost effective than custom stick built panels.
  3. 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.

Early participation of space planners and end-users, working in partnership with your design team, may assist to guarantee that your facilities are adapting to and complying with these crucial criteria. This can help save time and money.

Does USP 800 apply to manufacturers?

In general, USP recommendations are applicable to compounding pharmacies and drug manufacturers; but, the USP 800 guidelines are applicable to any facility that handles hazardous medications; this means that whether you own or run a pharmacy, you are responsible for complying with these laws.

Why is USP 800 necessary?

The United States Pharmacopeial Convention (USP) General Chapter specifies rules for the safe handling of hazardous pharmaceuticals, with the goal of reducing the risk of exposure to patients, healthcare workers, and the environment. Download the USP GC for free.

Download the HazRx® Mobile App General Chemistry Infographic here. According to the National Institute for Occupational Safety and Health (NIOSH), a drug is considered to be hazardous if it displays carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs.

USP 800 What are the Risks? Pharmacy

These characteristics can be observed in humans or animals. The USP General Chapter details the standards that must be met, such as the duties of individuals who are in charge of handling hazardous pharmaceuticals; facility and engineering controls; procedures for deactivating, decontaminating, and cleaning; spill control; and recordkeeping.

When did USP 800 become official?

Appeals to revisions of two compounding standards were granted by an Appeals Panel of the United States Pharmacopeial Convention (“USP”) on March 12, 2020. These standards are General Chapter Pharmaceutical Compounding – Nonsterile Preparation (“Chapter 795”) and General Chapter Pharmaceutical Compounding – Sterile Preparations (“Chapter 797”).

  1. At the same time, an appeal to General Chapter Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging was turned down by the Appeals Panel.
  2. The appeals that were lodged against the changes of Chapters 795 and 797 have been sent back to the Compounding Expert Committee of the USP with a request for “additional engagement” on the problems that were brought up in the appeals.

Because of the rulings made by the Appeals Panel, the official versions of Chapter 795, which was most recently updated in 2014, and Chapter 797, which was most recently updated in 2008, will continue to be in force. The appeals were a direct consequence of the amendments that were made to Chapters 795 and 797, which were then made public on June 1, 2019.

  1. It is important to note that the status of Chapters 795 and 797 is crucial because of the influence that it has on the application of USP General Chapter (“Chapter 800”), which controls the proper and safe handling of potentially dangerous medications (“HDs”).
  2. Chapter 800 will continue to be “informational and not compendially relevant” since the existing official versions of Chapters 795 and 797 will continue to be in effect until the status of the 2019 modifications is fully settled.

Only when it is referenced in (a) a USP monograph, (b) another general chapter numbered below 1000, or (c) USP General Notices does a general chapter with a number lower than 1000 become compendially applicable and, as a result, a required standard. This is because the framework for USP’s standards states that this is the only way for a general chapter to become compendially applicable.

In the instance of Chapter 800, it is mentioned in the upcoming 2019 revisions of both Chapters 795 and 797; nevertheless, it is not included in the currently official editions of both chapters, nor is it mentioned in a monograph or in the General Notices. As a result, Chapter 800 will continue to serve an informational purpose, and it will not be compendially relevant until the revisions to Chapters 795 and 797 are completely settled.

So, what exactly does this imply for those who work in health care? Even while the informational standing of Chapter 800 is crystal obvious for the near future, it is still unclear how federal and state authorities will react to the new facts. The United States Pharmacopeia has made it abundantly clear that state agencies (such as State Boards of Pharmacy), other regulators (such as the Occupational Safety and Health Administration), and oversight organizations (such as The Joint Commission) are free to make their own judgments regarding the applicability and enforceability of Chapter 800 for organizations that fall under their purview.

  1. USP has also said that it continues to engage regulators, certification bodies, and stakeholders with the compendial status of Chapter 800, and that it provides information to these groups.
  2. Because the federal government and state governments are now trying to deal to the COVID-19 problem, it is safe to expect that efforts by regulators and oversight groups to execute any enforcement of Chapter 800 will be postponed.

This is because of the current state of affairs. Any such delay provides health care providers with the opportunity and time to evaluate how the provisions of Chapter 800 influence their operations and to implement any adjustments to their physical plant or operational procedures that are mandated by the results of that evaluation.

Regarding the 800th Chapter The management of HDs is governed by Chapter 800, which is not a regulation but rather a collection of practice and quality requirements that are in place from the time an HD is received at a health care institution until it is discarded (and beyond, when medical surveillance is factored in).

Chapter 800 became official on December 1, 2019; however, as was mentioned above, it will continue to be informational and will not be compendially applicable until the revisions to Chapters 795 and 797 are fully resolved. This is because Chapter 800 is dependent on Chapter 795 and Chapter 797 for its applicability.

The following topics are addressed by the regulations included in Chapter 800: Identification of Hazardous Disposal Items Types of Exposure Responsibilities of Staff Handling Hazardous Disposal Items Facilities and Engineering Controls Controlling the Quality of the Environment Personal Protective Equipment Staffing and training for the Hazard Communication Program and receiving Labeling, Packaging, Transport, and Disposal Dispensing The Complete Dosage Forms Compounding and administering HDs Deactivating, decontaminating, cleaning, and disinfecting the environment Compounding and administering HDs Spill control Guidelines and Operating Procedures Medical Surveillance Due to the fact that Chapter 800 is relevant in a number of different health care settings and is, as a result, quite comprehensive, not every standard will be applicable in every setting to the same degree.

As a consequence of this, it will be absolutely necessary for health care providers to become familiar with Chapter 800, and then to conduct a risk assessment that takes into account the HDs that are administered within the facility, the movement of HDs throughout the facility, staff members who may come into contact with HDs, and the quantification of the risk for exposure to HDs for each activity that is carried out within the facility.

After the risk assessment has been finished, an evaluation of the efficiency of the controls and containment mechanisms that are already in place has to be carried out so that it can be determined whether or not extra precautions need to be taken. Compounding may necessitate the use of specialized engineering controls; however, this is contingent on the kind of the operations that are being carried out in the facility.

In addition, there will be a requirement for the development of policies, processes, and training protocols with the intention of preventing or reducing exposure to HDs. In accordance with the requirements of USP Chapter 800, a person who is both qualified and trained is required to be designated as the individual in charge of formulating and carrying out appropriate procedures, supervising compliance, ensuring the competence of personnel, and ensuring environmental control in storage and compounding areas (as applicable).

  1. The hazards connected with HDs, from the perspective of both safety and compliance, must be “thoroughly understood” by the authorized person, since this is a requirement that is emphasized by USP.
  2. In addition to this, the authorized person is obligated to supervise any testing or sampling that takes place at the facility.

It is the responsibility of the facility staff that handles HDs to understand the fundamental practices and precautions, as well as to continuously evaluate them, in order to prevent harm to individuals being served by the provider, minimize exposure to staff, and minimize environmental contamination from HDs.

Is USP 800 a law?

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.

  1. Because USP 800 has not yet been made official, several state boards of pharmacy have decided not to implement or enforce it.
  2. Instead, they are likely to consider applying their own standards that are linked to the aspects of USP 800 that are being addressed.
  3. 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.

  1. 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.
  2. 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.

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