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Are You Ready for USP Compounding Regulations <795>, <797> and <800>?

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In 2012, the New England Compounding Company (NECC) had a problem when it was compounding sterile preparations of methylprednisolone acetate, an injectable that physicians administered to patients.

Some of the injections turned out to be contaminated—they contained fungus, bacteria or mold. This led to a nationwide fungal meningitis outbreak in which 76 people died and about 700 people sustained permanent injuries, including paralysis. The outbreak was the largest public health crisis ever caused by a pharmaceutical product, according to the U.S. Food & Drug Administration (FDA). Investigators determined additional drug compounding regulations were needed to help prevent future occurrences.

This ushered in new regulations across the industry, including changes that will take place December 1, 2019. In addition, new standards (The Joint Commission) related to medication compounding for home care organizations became effective January 1, 2018. Organizations that are not currently in compliance are at risk of fines.

The standards—the new Medication Compounding Chapter in the Home Care Accreditation Program—were designed to ensure appropriate procedures for the compounding and distribution of sterile infusion products as described in the national standards and federal and state regulations are maintained. These standards took effect this year.

Because the USP Chapter <800> standards that take effect in December 2019 will be significantly different from current standards, healthcare organizations must begin preparing for them now. The regulations will cover any facility area where hazardous drugs are handled, including:

  • Receiving
  • Preparing
  • Storing
  • Transporting
  • Administering
  • Disposing of the drug

Here’s what the regulations change and the steps facilities can take to prepare for them:

Compounding Pharmacy Regulations Set Minimum Best Practices

The FDA regulates pharmacies. Traditional compounding, such as compounding for a specific patient, is called 503a from the section of the FDA’s Food, Drug and Cosmetic Act (FDCA) that outlines regulations for compounding drug products. The 503a section includes pharmacies in hospitals and home infusion centers, which are also governed by state boards of pharmacy. The rules are sometimes different from 503b compounding, which covers outsourcing facilities.

The Centers for Medicare & Medicaid Services (CMS) and The Joint Commission are also involved in compounding regulations. While the United States Pharmacopeia (USP) is not a regulatory agency, the non-profit develops best practices for compounding. When compounding achieves best practice standards, it's considered "USP Grade." Best practices are compiled in USP Compendia documents called chapters, and chapters under "1000" can become regulations enforceable by the FDA and state boards of pharmacy.

If an organization receives Medicare or Medicaid funding, it must follow USP regulations for compounding. USP Chapter <797> sets the minimum best practices for compounding sterile preparations. Their revised regulation effective date of December 1, 2019, is designed to match the implementation date for USP Chapter <800>, which addresses the handling of hazardous drugs in a healthcare setting. Organizations will need to comply with both chapters. 

To meet the upcoming regulations, healthcare organizations should perform a gap analysis that compares their current state to where they need to be for compliance. This will show areas that must be updated.

Are the Regulations Necessary?

Critics of the proposed regulations say they're overkill and unnecessary. However, with nearly 8 million U.S. healthcare workers potentially exposed to hazardous drugs, the regulations are designed to protect those workers and the environment around them. 

A 2010 study found significantly higher rates of specific types of chromosome abnormalities—changes to the body's DNA—among healthcare workers handling antineoplastic drugs. The study that first prompted regulations dates back to 1999. That's when pregnancy outcomes among nearly 3,000 nurses, pharmacists and pharmacy technicians were compared against non-healthcare workers. The risk of spontaneous abortions, miscarriages or stillbirths was 40% higher in women handling hazardous drugs during pregnancy.

6 Steps Healthcare Organizations Should Take Now

To meet the upcoming regulations, healthcare organizations should perform a gap analysis that compares their current state to where they need to be for compliance. This will highlight areas that must be updated. The analysis should identify areas of noncompliance across the entire organization, not just the pharmacy. 

Organizations should then develop a hazardous drug management strategy. The strategy should meet applicable state regulations in addition to those of the USP and FDA. It must be actionable, prioritize implementation needs and follow these six steps:

Step 1. Complete Facility and Engineering Updates

Adhering to the compliance mandates may require organizations to make changes to their facilities and engineering controls. This will require planning, scheduling and funding. The new regulations will cover:

  • Receipt and Unpacking. Antineoplastic hazardous drugs and all hazardous drug active pharmaceutical ingredients (API) must be unpacked in an area that has neutral or negative air pressure relative to the surrounding areas. This way, if something is spilled or broken, it won’t spread via positive pressure.
  • Storage. Antineoplastic drugs requiring manipulation, including refrigeration, and any hazardous drug APIs must be stored separately from other drugs. The hazardous drugs must be stored in an externally ventilated, negative-pressure room with at least 12 air changes per hour (ACPH). 
  • Non-Sterile Hazardous Drug Compounding. A contaminant primary engineering control (C-PEC) is not required if drug manipulations are limited to handling the final dosage forms that do not produce particles, aerosols or gasses.
  • Sterile Hazardous Drug Compounding. A laminar airflow bench (LAFW) or compounding aseptic isolator (CAI) must not be used for the compounding of antineoplastic hazardous drugs.

Step 2. Determine Hazardous Drugs

Once facilities have their construction needs planned, they should identify hazardous drugs in which they handle. The 34 drugs added to the National Institute for Occupational Safety and Health (NIOSH) list in 2016 brought the number of NIOSH defined hazardous drugs to 264[MB1] .

Each organization must create a list of the hazardous drugs it uses, including all dosage forms of HDs. The list should be reviewed every 12 months and compared to the NIOSH list.

Step 3. Perform a Risk Assessment

Organizations should conduct an annual risk assessment to ensure they are following proper protocols for hazardous drugs. An assessment is also recommended whenever changes are made that impact occupational exposure, such as adding a new drug or process, or using a non-formulary drug.

The risk assessment should identify any potential risks for each hazardous drug, the consequences of that risk and how to mitigate the risk. Organizations must follow the standards for Group 1 (chemotherapy) agents or they can establish alternative practices for Group 2 (Non-chemotherapy, hazardous drugs) or Group 3 (reproductive risk) drugs to protect their employees.

Step 4. Develop Standard Operating Procedures

Healthcare facilities need to establish procedures for handling hazardous drugs. The procedures must cover the entire drug cycle, from receiving to compounding to administering to disposal of the drug.

The operating procedures should also cover additional aspects of handling the drugs. This includes proper hand hygiene, transporting the drugs and the management of spills.

Step 5. Train Personnel

All employees who handle hazardous drugs must be trained on the operating procedures that relate to their job functions. Each employee must demonstrate that he or she understands the training.

Hazardous drug competencies must be reassessed at least every 12 months. All training and competency assessments must be documented.

Step 6. Provide Quality Assurance

Once everything is in place for compliance, organizations need to establish a quality assurance program. This entails checking for microbial contamination and sampling surfaces for hazardous drug residue. Facilities should start a formal wipe sampling and medical surveillance programs to monitor HD exposure. 

The new regulations call for a compounding supervisor, which is a designated person responsible for ensuring the regulations are followed. This person is charged with documenting training and risk assessments, overseeing the program, and ensuring quality assurance.

Third-Party Gap Analysis

Organizations can perform a gap analysis by visiting HazMedSafety.com or CompoundingToday.com. The sites offer help for an analysis and can recommend an action plan. Likewise, Provista can perform an analysis and develop an actionable plan for customers.

Hazardous Drug Worker Protections

The new USP Chapter <800> standards are designed to promote environmental, patient and worker safety. Unlike existing regulations, these apply to all healthcare personnel who handle hazardous drugs, including those who transport, store, prepare or administer the drugs. The regulations will even apply to those who receive the shipments at the dock or clean rooms where the drugs are prepared.

Organizations need to be aware of the new rules and the potentially major operational, financial and technological changes required to become adherent. Facilities must start planning and budgeting for these changes now.  


Author Bio:

Katrina Harper, PharmD, MBA, BCPS, DPLA is a senior clinical manager for Vizient, contracting partner of Provista. Harper has more than 17 years of healthcare experience, including providing pharmaceutical and clinical expertise to internal teams and hospitals. Her areas of expertise include safe medication use, process improvement, pharmacy operations optimization and regulatory compliance. She is the lead subject matter expert on USP compliance for Vizient.

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