Sterile Compounding Explained: USP <797> and <800> Standards

Not all medications are prepared the same way. Some require a higher level of precision, environmental control, and safety to ensure they are appropriate for patient use. This is where sterile compounding becomes essential.

Sterile compounding involves preparing medications in a controlled environment to prevent contamination. It is commonly used for medications that must be free of bacteria and other microorganisms, such as injectable or infusion therapies.

What Is Sterile Compounding?

Sterile compounding is the process of preparing medications in a controlled, sterile environment to ensure they are safe for administration when sterility is required.

These medications are typically:

• Injected

• Infused

• Applied to sensitive areas such as the eyes

Because these medications bypass many of the body’s natural defenses, they must be prepared under strict conditions.

If you’re new to compounding, you can learn more in our overview of what a compounding pharmacy is.

Why Sterile Compounding Requires Special Standards

Unlike standard medications, sterile preparations must be protected from contamination at every step.

This includes:

• Controlled air quality

• Specialized equipment

• Trained personnel

• Strict cleaning and documentation procedures

These requirements are defined by established compounding standards.

What Is USP <797>?

USP <797> is a set of standards that governs sterile compounding practices in the United States.

It outlines requirements for:

• Cleanroom design and airflow

• Sterile compounding techniques

• Personnel training and competency

• Environmental monitoring

• Quality assurance processes

The goal of USP <797> is to ensure that sterile medications are prepared safely and consistently.

What Is USP <800>?

USP <800> focuses on the safe handling of hazardous drugs, including certain medications used in oncology, hormone therapy, and other specialized treatments.

It establishes guidelines for:

• Protecting healthcare workers

• Preventing exposure to hazardous medications

• Proper handling, storage, and disposal

USP <800> works alongside USP <797> to ensure both patient safety and staff safety.

When Sterile Compounding Is Used

Sterile compounding may be required for:

• Infusion therapies

• Injectable medications 

• Certain ophthalmic preparations

• Specialty treatments requiring sterile administration

These medications must be prepared in environments designed to maintain sterility.

How Sterile Compounding Differs from Non-Sterile Compounding

Non-sterile compounding includes medications such as creams, capsules, and oral liquids.

Sterile compounding, on the other hand:

• Requires controlled cleanroom environments

• Uses specialized airflow systems

• Follows stricter regulatory standards

• Involves more rigorous documentation and monitoring

Both are regulated, but sterile compounding has additional safeguards due to the nature of the medications.

Is Sterile Compounding Regulated?

Yes. Sterile compounding is highly regulated.

Compounding pharmacies are:

• Licensed and inspected by the State Board of Pharmacy 

• Subject to FDA inspection 

• Required to follow USP <797> and <800> standards 

These regulations are in place to ensure patient safety and product quality.

Sterile Compounding at Dr. Aziz Pharmacy

Dr. Aziz Pharmacy performs sterile compounding in accordance with USP <797> and <800> standards, supporting prescribers and patients who require customized sterile medications.

We provide sterile compounding as part of our broader compounding and specialty pharmacy services, including infusion therapy and individualized treatment preparation.

Our pharmacy serves patients and prescribers throughout Indianapolis and Indiana, maintaining a strong focus on safety, accuracy, and regulatory compliance.

When to Talk to Your Healthcare Provider About Sterile Compounding

You may want to speak with your provider if:

• A medication requires sterile preparation

• Commercial sterile products are not available

• Your treatment involves infusion or injectable therapy

• A customized sterile formulation may be needed

Your provider can determine whether sterile compounding is appropriate for your care.

Frequently Asked Questions About Sterile Compounding

What is sterile compounding?

Sterile compounding is the preparation of medications in a controlled environment to prevent contamination when sterility is required.

What does USP <797> mean?

USP <797> is a set of standards that governs how sterile medications are prepared to ensure safety and quality.

What does USP <800> mean?

USP <800> provides guidelines for safely handling hazardous drugs to protect both patients and healthcare workers.

Are sterile compounded medications regulated?

Yes. They are regulated by state boards of pharmacy, may be inspected by the FDA, and must follow USP standards.

Do all pharmacies perform sterile compounding?

No. Sterile compounding requires specialized facilities, equipment, and training that many pharmacies do not have.

*These statements are culmination of the knowledge and experience of the team at Dr. Aziz Pharmacy. The information provided here is for informational purposes only. Please consult your healthcare provider with questions concerning any medical condition or treatment. Compounded medications are not reviewed by the FDA for safety or efficacy. This article was generated with assistance from ChatGPT. All AI-generated content is reviewed by our clinical team for accuracy. This content is for informational purposes only and is not medical advice.