Quality Assurance & USP 800 Compliance

Pharmaca & USP <800>

Our Compounding Centers were designed with specialized state-of-the art compounding equipment, high-tech software and enhanced computer systems that enable us to compound each medication to the prescriber’s exact specifications.

The facilities and staff are compliant with USP <800> guidelines that are now required by the federal government. They are ISO 7 certified, and feature a negative pressure room with HEPA filter-equipped compounding hoods. And our advanced MAZ Machine provides a consistent finished compound every time.

Staying up to date on and adhering to the latest government standards when it comes to prescription compounding is paramount for us in order to keep our patients and staff both safe and protected, not to mention as healthy as possible.

Here’s more about the USP <800> regulations taking effect December 1, 2019.

What is USP <800>?

USP <800> describes requirements for standardizing the safe handling of hazardous drugs. The updated USP <800> compliance requirements include:

  • Increased responsibilities for personnel handling hazardous drugs
  • New facility and engineering protocols
  • Procedures for deactivating, decontaminating and cleaning
  • Spill control
  • Documentation

The new USP <800> guidelines were developed with coordination between several agencies, including USP Compounding Expert Committee, USP Compounding with Hazardous Drugs Expert Panel, the FDA and the CDC.

Who does USP <800> affect?

The new regulations affect health care personnel as well as entities who receive, prepare, administer, transport or come in contact with hazardous drugs. Those entities can include pharmacies, hospitals, health systems and other health care institution personnel, patient treatment clinics, among others.

Why is this happening?

The USP Compounding Expert Committee developed General Chapter <800> in order to standardize safe handling of hazardous drugs throughout all health care environments in the United States. This is so that patients and health care workers get better protections from hazardous drugs.

The National Institute for Occupational Safety and Health (NIOSH) classifies a drug as hazardous if it exhibits one or more of the following characteristics in humans or animals: 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.

Key USP <800> changes

There are a number of new requirements and regulations that come with the upcoming USP <800> update, ranging from handling to storage to drug administration.

Some of the new requirements include, but are not limited to, the following:

Hazardous drugs must maintain certain lists used in their facilities, such as:

  • ID new drugs that enter the market
  • Hazardous Drug list reviewed annually
  • Complete a risk assessment including drug type, dosage form, exposure risk, packaging and manipulation

 Staff and facilities must identify types of exposure, such as:

  • All potential exposure based on staff responsibilities and activity
  • Potential routes of exposure

 Personnel responsibilities and training:

  • Health care providers are required to designate a trained individual to develop, implement procedures and standards, oversee compliance, training and monitoring of personnel handling hazardous drugs.
  • Any person who handles hazardous drugs must be trained based on the function of their job, before they handle any hazardous drugs, including receiving, labeling, packaging, transport, disposal, administration, deactivation, decontamination, cleaning and disinfection of hazardous drugs and where they’re handled.
  • Anyone who handles hazardous drugs must adhere to the standards for wearing personal protective equipment while mixing or administering the hazardous drugs.

 Personal protective equipment (PPE):

  • Health care entities must develop standard operating procedures for PPE based on the risk of exposure and the activities performed with the hazardous drugs being handled.
  • Gloves: Two pairs of chemotherapy gloves are required for administering antineoplastic hazardous drugs.
  • Gowns: Disposable gowns are required, as well as shown to resist permeability by hazardous drugs.
  • Covers: Personnel has to use covers for head, hair, shoe and sleeve covers.
  • Eye and Face: Eye and face protection must be worn if there’s a risk of spills or splashes or with waste materials. Goggles must be worn for eye protection.
  • Respiratory Protection: A full face respirator is required, chemical cartridge-type or powered respirator (PAPR) should be worn during respiratory exposure to HDs to help reduce the risk of spills or splashes of hazardous drugs or hazardous drug waste materials.

 Drug administration:

  • Health care personnel who administer hazardous drugs must use compliant protective medical devices and techniques, while wearing appropriate PPE.

Pharmaca is USP <800> ready

Pharmaca adheres to strict safety and handling procedures, including all of the compounded medicine we make for our clients. Compounds are filled at our state-of-the-art Compounding Centers located across the United States, meaning we can create compounded medication to the prescriber’s exact specifications.

We are also proud members of the Professional Compounding Centers of America (PCCA), and our facilities are all USP <800> compliant, so you can be sure that every drug is handled safely and all of our facilities maintain the strictest US government regulations and standards.

If you have any questions on our USP <800> regulations and how we maintain the materials we handle in creating our compounded medications, contact our compounding centers for more information.