Did you ever write a book report using only CliffsNotes?

I did. And surprisingly did just fine.

My junior year of high school CliffsNotes seemed like a necessary replacement for actually reading a 600 page Victorian novel. It was a little risky to forego reading the actual book, but those little pamphlet summaries saved my time and grades.

But when it comes to pharmacy regulations, specifically USP 800, there’s a lot less pages to read (only 17) except the stakes are much higher than a book report.

Have you read USP 800 yet? It’s provided plenty of controversy in pharmacy. We’re simplifying things for your retail pharmacy.

In a retail setting, the majority of your products are final dosage forms of these medications that do not require any further manipulation beyond counting and packaging. We broke down this chapter based on that assumption.

Let’s just break this down a little bit.

USP 800 has 18 sections across 20 pages, here’s the CliffsNotes version

Section 1: Introduction

This section describes the purpose of the chapter and what areas must be covered by the entity (the pharmacy) which we will go into in the subsequent sections.

Section 2: List of Hazardous Drugs

The pharmacy must maintain a list of Hazardous Drugs (HD) that it handles.

This list is based off the National Institutes for Occupational Safety and Health publication from the CDC.
The list must include all dosage forms of a drug that the pharmacy handles. (Some dosage forms have a higher risk of exposure than others.)
Must be reviewed at least every 12 months and documented.

Certain drugs on the list must follow USP 800 containment requirements (manipulated in a negative pressure space):

HD APIs- applies to compounding.
Any anti-neoplastic that requires manipulation beyond counting and packaging.
This criteria SHOULD NOT apply to a retail store.

Other HDs may have an alternative containment strategy ONLY if the pharmacy performs an Assessment of Risk on each dosage form of the HD.

I will get into more details of this section in the next article because this DOES apply to retail.

Section 3: Types of Exposure

Examples of exposure from each step in the handling of HDs

Receipt: Receiving broken containers from your wholesale distributor
Dispensing: residue exposure from final dosage forms through skin contact or inhalation
Manipulations (that are not compounding): crushing or splitting tablets, transferring oral liquids into another container, reconstituting powders
Spills
Transport: only if you move HDs from your pharmacy department to another department, like a clinic in the same space
Waste: handling trace waste without proper PPE

Section 4: Responsibilities of Personnel Handling Hazardous Drugs

The pharmacy must have a designated person who is in charge of overseeing the development and implementation of your USP 800 compliant policies and procedures.

This person must also have documented training to be able to perform such duties

Section 5: Facilities and Engineering Controls

This section goes into detail of your facility’s space/ environment in consideration to handling HDs.

This is where your pharmacy’s alternative containment strategy comes into play.
Designated areas should be labeled and easy to identify.
Designated areas should also be away from break rooms, areas where staff eat/drink, and high traffic areas that risk exposure to other staff not wearing PPE or visitors to the pharmacy.

5.1 Receipt:

Antineoplastic HDs (from Table 1 of NIOSH List) must be unpacked in an area that is neutral/normal or negative pressure relative to the surrounding areas.
So create a designated space, mark it off and label it as “Hazardous Drug Receiving”

5.2 Storage:

Store drugs in a way that prevents spilling, like raised lips on the shelving.
Do not store HDs on the floor.
You must have a separate refrigerator for any anti-neoplastic HDs that requires refrigeration.
As long as you have and assessment of risk that justifies it, final dosage HDs may be stored with your regular stock- Just mark them as Hazardous so all staff know which are HDs.

5.3 and 5.4 Compounding:

Doesn’t apply to retail

Section 6: Environmental Sampling

As of right now, this is a “should” rather than a “must”…. and not really feasible to accomplish with final dosage form HDs that do not require additional manipulation. So doesn’t really apply to retail pharmacies at this point.

Section 7: Personal Protective Equipment

Describes what should be worn in certain scenarios: receiving, counting, transporting, spill clean-up.

This will be determined by your Assessment of Risk for each HD dosage form
Can include masks, gloves, gowns, shoe covers, goggles, respirators
PPE cannot be reused
I will go into more detail over this in a later article, “SOPs and Supplies”

Section 8: Hazardous Communication Program

Your pharmacy should already have this, aka your HAZCOM program. If not, I go into more detail in a later segment with SOPs.

Section 9: Personnel Training

Your SOPs must have a section for documented training for each staff member that handles HDs. The training must include:

Overview of HD List
Review of the pharmacy’s HD SOPs
Proper use of PPE and any devices
Response to exposure (part of your HAZCOM program)
Spill management and disposal

Section 10: Receiving

Staff must wear gloves when receiving HDs and a spill kit must be near by
Describes what to do if you receive a damaged or open container
- Don’t open, seal back up, contact supplier, mark as hazardous when shipping back

Section 11: Labeling, Packaging, Transport, and Disposal

HDs must be able to be identified through proper labeling during transport
Use containers and shipping supplies that prevent spilling or leakage of HD during transport
Disposal of contaminated PPE must be disposed of according to federal, state, and local laws.

Almost there…

Definitely pay attention to this one.

Section 12: Dispensing of Final Dosage Forms

Final dosage forms that do not require any further manipulation beyond counting and packaging DO NOT require containment UNLESS:
- specified by the manufacturer (refer to the PPI)
- or you can visually see exposure risk is present (HD dust or leakage)
Alternative Containment strategy: Use dedicated trays and spatulas and decontaminate after every use.
Tablet and capsule forms of anti-neoplastic HDs cannot be placed in automated counting or packaging machines (i.e. Kirby Lester, Parata, Script Pro)

Section 13: Compounding- n/a to Retail

Section 14: Administering- n/a to Retail

Section 15: Cleaning

All areas and equipment used for HDs must be deactivated, decontaminated, and cleaned. Staff must be trained on these procedures.

Deactivation: makes the HD inert or inactive
Decontamination: Removes the HD residue
Cleans: removes organic and inorganic material
Proper technique should be to spray onto a wipe, not spray the surface and risk spreading the HD residue
Products will be discussed in a later segment

Section 16: Spill Control

Staff must be trained before handling HD spills and using proper PPE, like respirators
Spill contents must be disposed of as hazardous waste
Spill circumstances and clean up must be documented

Section 17: Documentation and Standard Operating Procedures

Your pharmacy must have SOPs regarding every section of USP 800, so if I just went over it, you should have it in a written SOP.

Section 18: Medical Surveillance

This is seen as as secondary prevention tool to monitor any adverse health events. But here’s what to know:

Your staff can elect to not participate in this
Monitoring is at no cost to them
Monitoring parameters can be based on risk of exposure
If you have an HR company- ask them if they have department to help address USP 800 compliance.

So in summary, every section applies to retail-only pharmacies except sections 5.3, 5.4, 13 & 14.

Next up: How to perform an Assessment of Risk

References:

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USP 800 CliffsNotes for Retail Pharmacies