USP <800> Hazardous Drugs Labels

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R.J. Hedges offers the only customized program for retail pharmacies to become USP <800> compliant.  With the December 1, 2019 deadline approaching, what are you doing to prepare?
 

Most Frequently Asked USP <800> Questions by Independent Pharmacies


Is USP <800> just for compounding?

USP <800> affects all types of pharmacy operations including retail pharmacy, LTC pharmacy, compounding pharmacy, and every other facility with the word pharmacy associated with it because every pharmacy has the ability to handle and dispense hazardous drugs.  Failure to comply with USP <800>, which goes into effect on December 1, 2019, can impact both your pharmacy license and the pharmacist-in-charge license.

Is this a federal or state requirement?

USP <800> is a federal requirement that will be enforced by the State Board of Pharmacy and the State Department of Environmental Protection.

Do we need a separate binder for the Hazardous Drugs and the Assessments of Risk?

We recommend that Assessments of Risk be maintained in a separate binder so that the information is readily available for state inspectors.



Do I need to write down the drugs we have that are just listed on the NIOSH list? For example, ketoprofen is NOT on the NIOSH list; however, it is considered hazardous and has an extra hazard shipping charge.

A drug may be classified as a hazardous drug, a hazardous material, both a hazardous drug and a hazardous material, or neither a hazardous drug nor a hazardous material. Hazardous drugs are classified by the U.S. Department of Health & Human Services using the NIOSH standards, and, therefore, must be included on your list as you identify and inventory USP <800> Hazardous Drugs in your pharmacy.

Hazardous materials are classified by the U.S. Department of Transportation and use a completely different set of standards related to shipping. Therefore, a drug that is NOT on the  NIOSH List but that carries a hazard shipping charge, for example, ketoprofen, would not be included in your USP <800> Hazardous Drugs Inventory list.

Do we need to list hazardous drugs that we had in our inventory in the past or only currently and moving forward?

Any/all hazardous drugs currently in your pharmacy must be included in your Hazardous Drugs Inventory list. The Hazardous Drugs Inventory list should be updated when a new hazardous drug is received.  There is no need to include previous hazardous drugs that are no longer in inventory.

What if I don’t manipulate the drug in any way? Does it still need to go on my Hazardous Drugs  Inventory list?

Yes, any drug on the NIOSH List that is in your pharmacy must be included on your Hazardous Drugs Inventory list.

Is warfarin on the hazardous drugs list?

Yes, warfarin is listed as a Table 3/Group 3 drug on the NIOSH List. For additional questions regarding specific drugs, please refer to the NIOSH List.



Do hazardous drugs have to be separated on different shelves or in a different area all together?

Hazardous drugs must be segregated from all other pharmacy drug stock. This can be accomplished by using a separate shelf, counter, rack, cabinet, or room, whatever works best for your pharmacy depending on the quantity of hazardous drug inventory that you stock.  The segregation area must be marked with a “Hazardous Drug Storage Area” sign.

What do we do with hazardous drugs that need to be refrigerated?

As with non-refrigerated hazardous drugs, refrigerated hazardous drugs must be segregated from all other refrigerated pharmacy stock. This can be accomplished by using a separate shelf, bin, or drawer or a separate refrigerator, depending on the quantity of refrigerated hazardous drug inventory that you stock.  The segregation area must be marked with a “Hazardous Drug Storage Area” sign.

Can we purchase special “red” labels to help identify hazardous drugs to assist in ensuring they are put back on the correct shelf?

Yes, you certainly may purchase and use a labeling system, or create your own, if you believe it will be helpful for you and your staff.

 



Do we have to handle hazardous drugs in sealed packs with gloves?

Hazardous drugs received in a sealed pack, requiring no manipulation, counting or repackaging, may be handled without the use of gloves.  For clarification on personal protective equipment necessary for handling a particular hazardous drug, refer to the drug’s Safety Data Sheet (SDS).

Can a hazardous drug be put on a tray counter that does not go into a machine to be counted?

Yes, a tray counter may be used when counting and dispensing a hazardous drug. Equipment (for example, a tray counter) used in counting and repackaging of hazardous drugs must be designated for hazardous drugs only and decontaminated after each use.

Currently, only the Eyecon Visual Precision Counting System is the only pill counter that is USP <800> compliant.  It is recommended that a different color of tray counter be purchased for use with hazardous drugs than the color of tray used for other pharmacy stock.



Do I need to have an SDS for each drug?

Yes, a hard copy of the SDS is preferred for each hazardous drug on your Hazardous Drugs Inventory. The SDS should be maintained in the Hazardous Drugs Binder or in the Compliance Binder under the Hazardous Drugs tab behind the Assessment of Risk.

Where do I get the SDS?

You can do your own on-line search, request an SDS from your wholesaler, or you can search and locate an SDS using the NIOSH List.

How do I search the NIOSH List?

Go to the NIOSH List. You will need to scroll down through 9 pages before the drug lists start.  The drugs are divided into 3 tables/groups:

  • Table 1/Group 1: Antineoplastic drugs, including those with the manufacturer’s safe-handling guidance (MSHG).
  • Table 2/Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug, including those with the manufacturer’s safe-handling guidance (MSHG).
  • Table 3/Group 3: Non-antineoplastic drugs that primarily have adverse reproductive effects.

Once you find the drug you need, follow the row straight across and click on the “DrugBank”

  • Hit “Ctrl F” to bring up a search bar in the bottom left corner of your screen.
  • Type “MSDS.” If there is a MSDS/SDS sheet available, you can print it.

NOTE: The DrugBank website is scheduled to be updated in June 2019.  Hopefully all of the MSDS sheets will be posted with this update.



Do we need an assessment of risk done for each strength of the same drug?

The Assessment of Risk for each drug in Table 1/Group 1 of the NIOSH List must list each drug and dosage form individually because dosage forms of drugs within the same group might not have the same risk of exposure. For example, priming an intravenous line may have more risk of exposure than dispensing tablets without further manipulation.

Drugs listed in Table 2/Group 2 or Table 3/Group 3 of the NIOSH List that fall into the same drug brand/generic, i.e. birth control or testosterone injections, may be placed on one Assessment of Risk form. If a Group 2 or Group 3 brand drug does not have multiple generics, an individual Assessment of Risk should be completed for that drug.

What does manufacturer’s packaging mean?

Manufacturer’s packaging means the hazardous drug is packaged in a sealed unit, and the pharmacist dispenses the drug without opening the drug container (i.e., birth control pills).



How do I dispose of a hazardous drug that has expired?

Expired drugs whether they are on the shelf as full or partial bottles are considered hazardous waste.  These drugs must be placed into the quarantine area and segregated as “hazardous waste.”  Hazardous waste must be disposed of in accordance with the EPA’s Resource Conservation and Recovery Act (RCRA).  The pharmacy’s return’s company or Stericycle offer the best solutions for disposal of expired hazardous drugs.



What is USP in pharmacy?

USP is defining <800> as the practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection.

What is the purpose of USP 800?

United States Pharmacopeia or USP and the Food and Drug Administration (FDA) have worked to update guidelines in order to avoid another tragedy like the New England Compounding Center tragedy that killed 64 patients and infected 793 patients due to unsafe practices and gross negligence.  It also serves to help protect not only the practitioners handling these HDs but also the other patients whose drugs may become contaminated by coming in contact with contaminated devices.

What does USP regulate?

USP <800> regulates the handling of hazardous drugs including but not limited to the receipt, storage, compounding, dispensing, administration, and disposal of sterile and non-sterile products and preparations.

Who enforces USP?

USP <800> is a guideline that FDA adopted as a federal regulation that will be enforced by state boards of pharmacy.

What are the three types of hazardous drugs?

The National Institute for Occupational Safety and Health (NIOSH) divides hazardous drugs into 3 groups:

  • Table 1/Group 1: Antineoplastic drugs, including those with the manufacturer’s safe-handling guidance (MSHG).
  • Table 2/Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug, including those with the manufacturer’s safe-handling guidance (MSHG).
  • Table 3/Group 3: Non-antineoplastic drugs that primarily have adverse reproductive effects.


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We have been associated with R.J. Hedges & Associates since 2009. We have the utmost respect for R.J. Hedges and his team! We are an Independent Pharmacy, and having to maintain compliance with a number of organizations including CMS with Medicare, State Board of Pharmacy, DEA, FDA, USP<800> and State Medicaid Programs. We are extremely pleased with the services we have received from R.J. Hedges & Associates. They are always on top of mandatory changes within the programs, and they make it easy for the Independents to keep up with the current Policies & Procedures to be compliant and accredited. One may argue of the cost of their services, but we feel it is an investment into out business!

Brenda J. Weber, R.Ph. Clearfield Pharmacy

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The R.J. Hedges Hazardous Drugs Compliance Program includes:


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  • Assessment of Risk
  • Hazard Communication Plan
  • Hazardous Drug Inventory
  • Hazardous Drug Training
  • Policies & Procedures including Final Dosage and Best Practices
  • Updates when Regulations Change
  • 24/7 Access to files via Compliance Portal®
Want to learn how RJ Hedges can help your pharmacy with compliance? Schedule a 1-on-1 Session Today

You may want to work with a consultant if:

  • You are unsure how to implement USP <800> in your Retail
    Pharmacy
  • You don't have time to create your own policies and
    procedures
  • You don’t know how to create and prepare an Assessment
    of Risk for each Hazardous Drug
  • You don’t know when a Hazardous Drug becomes a
    Hazardous Waste

Why prepare now?

  • The federal implementation date is  December 1, 2019
  • All Retail Pharmacies dispensing any Hazardous Drug on the NIOSH List must comply
  • Be prepared for inspections from state Board of Pharmacy, FDA, EPA, and State Department of Environmental Protection
  • Create a safety net for compliance
  • Protect your pharmacy and pharmacist license

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