Most community pharmacies don’t compound with hazardous drugs, but that doesn’t mean you’re off the hook when it comes to USP 800 compliance. This standard, USP General Chapter <800> Hazardous Drugs: Handling in Healthcare Settings, applies to anyone who receives, stores, or dispenses hazardous drugs (HDs). And yes, that includes community pharmacies.
What Makes a Drug Hazardous?
NIOSH defines a drug as hazardous if it’s linked to cancer, reproductive harm, organ damage, or genetic effects. There are over 250 medications that need to be handled safely to reduce potential harm to employees including medications commonly stocked in community pharmacies such as: azathioprine, carbamazepine, colchicine, finasteride, methotrexate, phenytoin, topiramate, warfarin, as well as hormone products including oral contraceptives.
Key Steps for Compliance
- Create and maintain a Hazardous Drug List and review it annually
- Develop written Policies and Procedures that outline your work practices for handling hazardous drugs
- Perform and document Risk Assessments for each hazardous drug/dosage form
- Purchase or create a Spill Kit to handle spills safely
- Wear Personal Protective Equipment (PPE) as determined by your policies and risk assessment
- Train your staff on safe handling practices, PPE, and spills (complete prior to handling hazardous drugs and then annually)
Why It Matters
A trace of powder left on a counting tray may seem harmless, but repeated exposure can cause long-term health risks. USP 800 isn’t just red tape, it’s about protecting your pharmacy team while they are handling hazardous drugs.
By taking small but consistent steps – hazardous drug list, risk assessments, PPE, training, and spill planning – community pharmacies can stay compliant and create a safer workplace for everyone.
PAAS Tips:
- Pharmacies interested in a turnkey USP 800 Compliance Program should review program details on the PAAS National® website or call (608) 873-1342 for additional information.
- The PAAS program is not intended for pharmacies that are compounding with hazardous drugs.
- For pharmacies that already utilize PAAS’ USP 800 program, ensure that you have reviewed the hazardous drug list based on NIOSH changes implemented in December 2024 as discussed in our May 2025 article, USP 800 Compliance Program Updates: NIOSH 2024 List
Billing Considerations That Will Save You Later
Filing and billing claims involves keeping track of what can feel like an endless number of details. The fast-paced environment of the pharmacy doesn’t always allow for keeping tedious details at the forefront of your mind. Below you’ll find a guide detailing common scenarios that should be considered while filling prescriptions to reduce your audit risk.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
The $40 Incentive Fee You Might Be Missing!
Since 2021, a program created by CMS has allowed eligible pharmacies to receive additional reimbursement for administering the COVID-19 vaccine to certain Medicare homebound patients.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Billing Ozempic® 0.25 mg Weekly as a Maintenance Dose – What is the Big Deal?
PAAS National® analysts field many questions on Ozempic® relating to off-label use; however, we also receive questions about what days’ supply to submit on claims – particularly for initiation dosing. Section 2.2 of the manufacturer package insert (available on DailyMed) lists the recommended dosage schedule based on clinical trials and includes the following titration schedule:
Pharmacies often see prescribers write for Ozempic® 0.25 mg weekly as a maintenance dose. What days’ supply should the pharmacy transmit?
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Easy Pickings: Why Transferred Prescriptions are Audit Bait
Transferring prescriptions into your pharmacy is usually great for business; however, pharmacies must be aware of the additional audit risks with these prescriptions. PBM audit algorithms easily identify transfers due to the origin code of 5 being submitted during claim adjudication.
Each state has requirements put in place by their pharmacy board that outline what information must be obtained and documented when transferring a prescription. These requirements differ from state to state, so be sure to educate staff on the state specific elements. Missing even one small piece of information can result in a recoupment during an audit.
One common mistake pharmacies make…
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Compliance Check: Is Your Authority to Vaccinate Still Valid?
Vaccine season is upon us! Pharmacies who offer immunization services are likely seeing an influx in requests for seasonal influenza, COVID-19, and other routine vaccines. However, it is important to take a step back and evaluate exactly which vaccines you are formally allowed to authorize and administer, especially after the meeting of the Advisory Committee on Immunization Practices (ACIP) on September 18th and 19th, 2025.
Pharmacies typically gain authority to administer (and/or prescribe) vaccines by one of four avenues:
During the September ACIP meeting, the committee voted to relax the recommendations for the 2025-2026 COVID-19 vaccine as follows:
In the August 2025 Newsline article, COVID-19 Vaccine Update: Shared Clinical Decision-Making, PAAS National® shared information regarding the CDC’s shared clinical decision-making approach. The CDC’s guidance was used to update the Advisory Committee on Immunization Practices approved vaccine schedules for children and adults for the 2024-2025 season. As of the time of publication of this article, the CDC had yet to issue its final recommendations for the 2025-2026 season. These updates are important because many state laws, CPAs and even the PREP Act tie back to the CDC and ACIP-approved vaccine schedules.
It is important to note that pharmacies who vaccinate pursuant to the PREP Act…
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
When Can a Wrong Origin Code Lead to Denial or Recoupment?
Per NCPDP’s Telecommunication Version D and Above: Questions, Answers and Editorial Updates, “the Prescription Origin Code (419-DJ) contains the value that represents the method in which the pharmacy originally received the prescription from the prescriber.” Any subsequent changes or modifications to the original prescription do not change the origin code even when clarifications of that prescription are done via telephone.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
USP 800: What Community Pharmacies Need to Know
Most community pharmacies don’t compound with hazardous drugs, but that doesn’t mean you’re off the hook when it comes to USP 800 compliance. This standard, USP General Chapter <800> Hazardous Drugs: Handling in Healthcare Settings, applies to anyone who receives, stores, or dispenses hazardous drugs (HDs). And yes, that includes community pharmacies.
What Makes a Drug Hazardous?
NIOSH defines a drug as hazardous if it’s linked to cancer, reproductive harm, organ damage, or genetic effects. There are over 250 medications that need to be handled safely to reduce potential harm to employees including medications commonly stocked in community pharmacies such as: azathioprine, carbamazepine, colchicine, finasteride, methotrexate, phenytoin, topiramate, warfarin, as well as hormone products including oral contraceptives.
Key Steps for Compliance
Why It Matters
A trace of powder left on a counting tray may seem harmless, but repeated exposure can cause long-term health risks. USP 800 isn’t just red tape, it’s about protecting your pharmacy team while they are handling hazardous drugs.
By taking small but consistent steps – hazardous drug list, risk assessments, PPE, training, and spill planning – community pharmacies can stay compliant and create a safer workplace for everyone.
PAAS Tips:
Real-World Examples of Fraud, Waste & Abuse and Audit Implications
It is no secret that margins are thin and pharmacies have been looking for additional revenue-generating opportunities. Some pharmacies have added immunization services, performed billable Medication Therapy Management, added Point of Care Testing, and/or found other non-PBM income sources to offset low (or negative) reimbursements from third-party payors. These services are patient-focused and can increase the community’s access to health care options, especially when primary care providers and health care clinics are less accessible. Providing these services to the community can help keep the pharmacy running.
Unfortunately, there are a few bad actors that have found unlawful revenue sources solely for their own financial prosperity. Audits are a method used (at least in part) to root out the activities of these bad actors by reviewing pharmacy claims, associated documents, and onsite resources to identify fraud, waste and abuse. Consider the following examples;
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Illegible Signature? Auditors Are Taking Note!
A recent audit trend shows that some major PBMs are challenging the perceived legitimacy of patient signatures. In particular…
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Where Can I Find PBM Provider Manuals?
Each PBM has their own unique set of “rules” for network pharmacies to follow, and they publish these rules in their Provider Manual. Pharmacies should be aware these Provider Manuals are an extension of the Provider Agreement and contractually obligate pharmacies to adhere to these requirements. To make matters worse, PBMs update these manuals at various frequencies with little to no communication.
Here is a summary of the major PBMs and how and where they provide access to manuals:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips: