Your Guide to USP<800>

It’s now August 2019 and we’re 3 months away from USP <800> becoming federally enforceable. But who is enforcing it? FDA, SBOP, CMS, TJC, ASHP, OSHA, Veterinary Board, Nursing board? 

First, USP is not a regulatory body, it is standards organization and has NO enforcement arm. Regulatory groups (FDA, OSHA, SBOP, CMS, TJC, ASHP, etc.) MAY adopt or accept USP standards as part of their enforcement reference standards. USP <800> had input from multiple credible sources (federal, private, & public entities) and mirrors OSHA standards closely.

Second, I hope we can clear up some misconceptions around the USP exemption for <800> that many believe keeps them from haveing to comply; this is simply not true. Let’s work backwards from the association level to board, to state, to federal.

Veterinary Boards – Are Veterinarians exempt?

The veterinary market is slow to adopt standards for safe handling and many rely on NIOSH recommendations from 2010. Some states require Veterinary practices to comply with NIOSH guidelines regarding HD’s: Washington, California and North Carolina. Others will refer to the SBOP to inspect and enforce such as GA, NH, OH, WA. State board of Pharmacies may also inspection of Veterinary clinics including NM, OK, IA. Many SBOP have oversight of narcotics in veterinary clinics and will inspect on that basis.

It actually might be even MORE important for veterinary practices to be compliant with <800> given the population they’re dealing with. Chemotherapies are not typically given to large animals in the same doses that a human would receive. A veterinary practice may be dealing with what already is a toxic, hazardous drug and administering doses much larger than a human practitioner (not a human doctor, a doctor FOR humans) would be giving.

Nursing Boards

Many nursing boards already follow strict standards that mirror NIOSH 2016 Safe Handling of Hazardous Drugs, and ONS guidelines.

TJC (The Joint Commission)

TJC has been slow to adopt USP <800> but will be expanding its inspections lists to include HD Compounding in the future. A spokesperson for The Joint Commission (TJC) in August said that an internal review of USP <800> was underway and that no decision had been made on whether it will be adopted by the accrediting organization. Those who have been working on USP <800> believe TJC will eventually enforce the standards.

SBOP (State Board of Pharmacy)

Some SBOPs are adopting USP <800> in its entirety, in part, or not at all. Check with your SBOP to verify their intent. If you’re a member of IACP they have produced a chart of each states’ intent as well as enforcement dates.

CMS (Centers for Medicare and Medicaid Services)

Many are unaware that if an organization receives Medicare or Medicaid funding, it must follow USP regulations for compounding.

CMS has established USP/NF chapters as the minimum threshold for quality that facilities must meet under the Medicare Program. This CMS guidelines explicitly states that USP Chapters <795> and <797> are the minimum standards for non-sterile and sterile compounding.

“All compounding of medications used or dispensed by the CAH must be performed consistent with accepted professional principles which are equivalent to or more stringent than those described in the compounding-related chapters in the USP/NF, which are recognized as authoritative standards regarding minimum standards of safe practice applicable to both sterile and non-sterile compounding.”

Revised State Operations Manual (SOM) Appendix W, Critical Access Hospitals, n.d.

The Centers for Disease Control

The Centers for Disease Control (CDC), is the FEDERAL agency responsible for the list of Hazardous Drugs that USP <800> refers to. CDC’s National Institute for Occupational Safety and Health (NIOSH) has been publishing a list of hazardous drugs for several years which includes chemotherapy medications, reproductive risk and others that all pose some level of risk to the humans manipulating (compounding) and/or administering.

NIOSH (The National Institute for Occupational Safety and Health)

The National Institute for Occupational Safety and Health (NIOSH) is responsible for conducting research and making recommendations for the prevention of work-related injury and illness. NIOSH is a non-regulatory agency, but guidance and recommendations issued by NIOSH are often used by other agencies responsible for developing and enforcing workplace safety and health regulations.

OSHA (Occupational Safety and Health Administration)

“Employers have a responsibility to provide a safe workplace.”

(Employer Responsibilities, n.d.)

“General duty clause, section 5(a)(1) of the OSH Act, continues to be applicable to all employers and requires each employer to provide employees a place of employment which is free from recognized hazards that may cause death or serious physical harm to employees”

 (OSHA Standard Interpretations, n.d.)

An OSHA spokesperson said in an email that the agency hasn’t adopted USP <800> as one of its standards, so the agency cannot enforce its compliance. OSHA advises employers to look to “industry standards and best practices for guidance.”

Given that, any entity who handles HD’s MUST comply with OSHA and/or their specific state sponsored OSHA. This is where many fail to realize OSHA already has regulations specific to hazardous (substances) drugs, and will enforce under General Duty Clause Section 5(a)(1) of the OSH Act and 29 CFR.

The OSHA standard 29 CFR 1910.1450 applies to laboratory. Preparation, dispensing, and administration often do not meet those definitions in full, however OSHA could potentially apply this rule with ease. Any time a hazardous drug is not in final dosage form these regulations will apply.

Laboratory use of hazardous chemicals means handling or use of such chemicals in which all the following conditions are met:

  1. Chemical manipulations are carried out on a “laboratory scale;”
  2. Multiple chemical procedures or chemicals are used;
  3. The procedures involved are not part of a production process, nor in any way simulate a production process; and
  4. “Protective laboratory practices and equipment” are available and in common use to minimize the potential for employee exposure to hazardous chemicals.

Laboratory – a facility where the “laboratory use of hazardous chemicals” occurs. A workplace where relatively small quantities of hazardous chemicals are used on a non-production basis.

Laboratory scale – work with substances in which the containers used for reactions, transfers, and other handling of substances are designed to be easily and safely manipulated by one person. “Laboratory scale” excludes those workplaces whose function is to produce commercial quantities of materials.

Work practices and containment strategies reduce exposure. The Hazard Communication is where these items should be spelled out and specific to each site. The focus being:

  • Protecting employees from health hazards associated with HDs,
  • Keeping exposures as low as reasonably achievable (ALARA)

Below are the OSHA standards related to HD related activities, many of which you will notice are written into USP<800>

General Industry 29 CFR 1910

1910 Subpart I

  • Hazardous waste operations and emergency response: 29 CFR 1910.120
  • PPE: OSHA 29 CFR 1910.132
  • Eye and Face Protection: 29 CFR 1910.133
  • Respiratory Protection Standard: 29 CFR 1910.134

1910 Subpart Z

FDA (Food and Drug Administration)

The FDA can enforce USP chapters under 1000. The FDA focus is the safety of the medication itself and the end consumer, and does not have standards for personnel safety, as this is a focus of OSHA. The FDA has robust standards in place and is already enforcing cross contamination of HD’s. 

In an email to the FDA a spokesperson said there are several provisions in the Federal Food, Drug, and Cosmetic Act pertaining to pharmacy compounding, but there’s no specific requirement to comply with USP <800>.

“States may require compliance with both Chapters <797> and <800>,”

FDA spokesperson in email communication

The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods & feed and veterinary products. (Food and Drug Administration, n.d.)

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Need HELP with USP <800> Compliance?? Reach out! 

About the Author:

Devin Wallace is the Founder of Wallace Ventures, human and veterinary consulting group. Devin is a nationally certified pharmacy regulatory and compliance specialist, educator, speaker, consultant for pharmaceutical compounding and product development. He has consulted over 1100 facilities nationwide on regulatory compliance.

References

(n.d.). Retrieved from United State Department of Labor:

Employer Responsibilities. (n.d.).

Food and Drug Administration. (n.d.). 

OSHA Standard Interpretations. (n.d.).

Revised State Operations Manual (SOM) Appendix W, Critical Access Hospitals. (n.d.). Retrieved from CMS.gov

AVMA Article: NIOSH to help improve drug safety in veterinary clinics

Today’s Veterinary Business: Are you Ready for USP <800>?

CDC VETERINARY SAFETY AND HEALTH; Hazard Prevention and Infection Control Recommendations for Employers

Important OSHA Legal Word References:

Chemical – means any substance, or mixture of substances.

Chemical manufacturer – means an employer with a workplace where chemical(s) are produced for use or distribution.

Classification– means to identify the relevant data regarding the hazards of a chemical; review those data to ascertain the hazards associated with the chemical; and decide whether the chemical will be classified as hazardous according to the definition of hazardous chemical in this section. In addition, classification for health and physical hazards includes the determination of the degree of hazard, where appropriate, by comparing the data with the criteria for health and physical hazards. 

Exposure or exposed – means that an employee is subjected in the course of employment to a chemical that is a physical or health hazard, and includes potential ( e.g. accidental or possible) exposure. “Subjected” in terms of health hazards includes any route of entry ( e.g. inhalation, ingestion, skin contact or absorption.)

Hazard category– means the division of criteria within each hazard class, e.g., oral acute toxicity and flammable liquids include four hazard categories. These categories compare hazard severity within a hazard class and should not be taken as a comparison of hazard categories more generally. 

Hazard class means the nature of the physical or health hazards, e.g., flammable solid, carcinogen, oral acute toxicity. 

Hazard not otherwise classified (HNOC) means an adverse physical or health effect identified through evaluation of scientific evidence during the classification process that does not meet the specified criteria for the physical and health hazard classes addressed in this section. This does not extend coverage to adverse physical and health effects for which there is a hazard class addressed in this section, but the effect either falls below the cut-off value/concentration limit of the hazard class or is under a GHS hazard category that has not been adopted by OSHA (e.g., acute toxicity Category 5). 

Hazardous chemical means any chemical which is classified as a physical hazard or a health hazard, a simple asphyxiant, combustible dust, pyrophoric gas, or hazard not otherwise classified. 

Health hazard means a chemical which is classified as posing one of the following hazardous effects: acute toxicity (any route of exposure); skin corrosion or irritation; serious eye damage or eye irritation; respiratory or skin sensitization; germ cell mutagenicity; carcinogenicity; reproductive toxicity; specific target organ toxicity (single or repeated exposure); or aspiration hazard. The criteria for determining whether a chemical is classified as a health hazard are detailed in Appendix A to §1910.1200¿Health Hazard Criteria. 

Immediate use means that the hazardous chemical will be under the control of and used only by the person who transfers it from a labeled container and only within the work shift in which it is transferred.

Laboratory – a facility where the “laboratory use of hazardous chemicals” occurs. A workplace where relatively small quantities of hazardous chemicals are used on a non-production basis.

Laboratory scale – work with substances in which the containers used for reactions, transfers, and other handling of substances are designed to be easily and safely manipulated by one person. “Laboratory scale” excludes those workplaces whose function is to produce commercial quantities of materials.

Mixture means a combination, or a solution composed of two or more substances in which they do not react. 

Physical hazard means a chemical that is classified as posing one of the following hazardous effects: explosive; flammable (gases, aerosols, liquids, or solids); oxidizer (liquid, solid or gas); self-reactive; pyrophoric (liquid or solid); self-heating; organic peroxide; corrosive to metal; gas under pressure; or in contact with water emits flammable gas. See Appendix B to §1910.1200¿Physical Hazard Criteria.

Produce means to manufacture, process, formulate, blend, extract, generate, emit, or repackage.

Production means an operation where a product is produced. Examples of production facilities are refineries, utility- generating companies, manufacturing plants. Multiple use of chemicals (the actual wording in the standard is “multiple chemical procedures or chemicals are used”) means using chemicals in laboratory procedures.

Protective laboratory practices and equipment means those laboratory procedures, practices and equipment accepted by laboratory health and safety experts as effective, or that the employer can show to be effective, in minimizing the potential for employee exposure to hazardous chemicals.

Reproductive toxins mean chemicals that affect the reproductive capabilities including adverse effects on sexual function and fertility in adult males and females, as well as adverse effects on the development of the offspring. Chemicals classified as reproductive toxins in accordance with the Hazard Communication Standard (§1910.1200) shall be considered reproductive toxins for purposes of this section.

Select carcinogen means any substance which meets one of the following criteria:1. It is regulated by OSHA as a carcinogen; or 2. It is listed under the category, “known to be carcinogens,” in the Annual Report on Carcinogens published by the National Toxicology Program (NTP) (latest edition); or 3. It is listed under Group 1 (“carcinogenic to humans”) by the International Agency for Research on Cancer Monographs (IARC) (latest editions); or 4. It is listed in either Group 2A or 2B by IARC or under the category, “reasonably anticipated to be carcinogens” by NTP, and causes statistically significant tumor incidence in experimental animals in accordance with any of the following criteria:a. After inhalation exposure of 67 hours per day, 5 days per week, for a significant portion of a lifetime to dosages of less than 10 mg/m3;b. After repeated skin application of less than 300 (mg/kg of body weight) per week; orc. After oral dosages of less than 50 mg/kg of body weight per day.

Substance means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurities deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

Use means to package, handle, react, emit, extract, generate as a byproduct, or transfer.

Additional Reading

The scope and application of HCS exempts drugs that are in solid final form, as per 29 CFR 1910.1200(b)(6)(viii). The final form exemption would also apply to tablets or pills

Hazard Communication Standard (HCS) requirements

non-solid, hazardous drugs are covered by the standard, and the physician employer would need to maintain a copy of the MSDS for such drugs and include these products in the workplace hazard communication program.

Tablets, capsules, or pills which are designed to be dissolved or crushed by employees prior to administration to a patient are not in “final form” and are covered by the HCS. There may be situations where the tablet, capsule, or pill is dissolved or crushed to facilitate patient administration when that is not typically the way it is dispensed. The “final form” exemption would apply in this situation.

Three situations exist where the HCS does not apply to drugs. First, the HCS does not apply to drugs which are packaged for sale to consumers in a retail establishment. Second, it does not apply to drugs intended for personal consumption by employees while in the workplace. And finally, when a drug is in solid final form for direct administration to the patient (i.e. tablets or pills). If however, the solid pill or tablet is pulverized or crushed to facilitate administration then it is covered by the HCS.

https://www.osha.gov/laws-regs/standardinterpretations/1993-05-11

Inspection Guidance for Inpatient Healthcare Settings

Other Hazards: In addition to the focus hazards listed above, and hazards that may be the subject of the programmed or unprogrammed inspection, other hazards that may be encountered in inpatient healthcare settings include, but are not limited to: 

  • Exposure to multi-drug resistant organisms (MDROs), such as Methicillin-resistant Staphylococcusaureus (MRSA).
  • Exposures to hazardous chemicals, such as sanitizers, disinfectants, anesthetic gases, and hazardous drugs.

Employee exposures to hazardous chemicals, such as sanitizers, disinfectants, anesthetic gases, and hazardous drugs (e.g. ,antineoplastic drugs), are also among the other hazards that are commonly encountered in inpatient healthcare facilities. A recent article in the American Journal of Infection Control notes that, in addition to environmental service workers, many other healthcare workers routinely use cleaning and disinfecting products. These chemicals are both irritants and sensitizers, causing a variety of adverse health effects, including eye irritation, irritant and allergic contact dermatitis, upper and lower respiratory symptoms, work-related asthma and chronic bronchitis. Note: Some cleaning and disinfecting chemicals are known to be mutagens, carcinogens and reproductive toxins.”

https://www.osha.gov/laws-regs/standardinterpretations/2015-06-25-0

The Hazard Communications Standard as it applies to employees who prepare and administer drugs/medications

The laboratory standard does not apply to a pharmacy operation mixing cytotoxic drugs. (Read Carefully)

Use of occupational exposure levels (OELs) for substances not covered by an OSHA Permissible Exposure Limit (PEL)

  • Hierarchy of controls for exposure to air contaminants

29 CFR 1910.1000 is a performance-based standard; it does not specify the engineering or administrative controls that an employer must implement to prevent exposures to unhealthy concentrations of air contaminants

Enforcement Policy for Respiratory Hazards Not Covered by OSHA Permissible Exposure Limits

Veterinary Rules/Regulations/Laws

Washington State Laws & Guidelines:

Washington State Hazardous Drug Program Guide

California State Law & Guidelines:

North Carolina State Law & Guidelines:

NIOSH Safe Handling of Hazardous Drugs for Veterinary Healthcare Workers (2010)

AVMAAdministration and dispensing of compounded veterinary drugs (August 2019)

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