Choosing a Compounding Pharmacy: 10-Point Checklist

January 27, 2026
Blog
Journal

Authors

Reviewed by Dr. Rasoul Montazeri

Triple Board Certified Physician and The Founder

Niayesh Najafi

Medical student and researcher in Health Sciences

Table of contents

What Compounding Pharmacies Do
The Importance of Safety and Quality in Compounding
Beginner’s Guide to Choosing a Compounding Pharmacy
Building Trust: Key Communication and Transparency Practices
Request a Consultation With Healthon
Frequently Asked Questions

Key takeaways

Personalized medications: Compounding pharmacies make custom medications when standard drugs don’t meet patient needs.
Safety first: Quality depends on strict USP standards to prevent contamination and dosing errors.
Verify compliance: Always check licensing, 503A/503B status, and access to quality documents like COAs.
Transparency builds trust: Reliable pharmacies communicate clearly, manage recalls properly, and prioritize patient safety.

Scientists in protective laboratory gear conducting pharmaceutical research and testing to ensure compound medication quality and safety

When your doctor tells you to use a compounded medication, you will be working with a part of healthcare that is more focused on your own needs. A compounding pharmacy makes medicine just for you. A regular pharmacy cannot do this. Getting medicine made just for you is good, but you also must make sure the pharmacy you pick is safe and trustworthy.

What Compounding Pharmacies Do

Illustration comparing different types of compounding pharmacies, including 503A and 503B facilities, to help patients choose a safe and compliant pharmacy

Compounding pharmacies focus on making compounded medication just for you. If the usual drug does not work for your needs, these pharmacies can help. For example, you may need a different dose, want a liquid and not a pill, or have to avoid something because you are allergic. In these cases, pharmacists will make a special formulation for you.

The Importance of Safety and Quality in Compounding

When it comes to compounded medications, there can’t be any mistakes. Patient safety and product quality matter the most. If there are no strong quality control measures, the medicine may not have the right dose. It may have things in it that should not be there, or worse, it could be contaminated. This can be very risky for people and put their health in danger.

Beginner’s Guide to Choosing a Compounding Pharmacy

Healthcare professional holding compliance checkmark representing USP standards, quality control, and pharmacy accreditation

With a clear picture of what defines a high-quality compounding pharmacy, the next step is putting that knowledge to use. Start by preparing the right questions and knowing where to find reliable information. This approach helps compare options and choose a pharmacy that meets quality and safety standards.

Verify Pharmacy Licensing and 503A Compliance

The first thing you need to do is make sure the place is a licensed pharmacy. You cannot skip this step. Regulatory compliance is a must. The best way to check is to go to your state board of pharmacy website. There, you will see if the pharmacy’s license is active and if there has been any trouble before.

If you need prescriptions made just for a patient, you will work with a 503A pharmacy. These pharmacies are watched by boards of pharmacy at the state level. You want to be sure they are doing things right.

Assess Sterility Practices and USP Standards Adherence

For medications that are given by injection or used in the eyes, it is important to follow sterile compounding practices. This helps stop serious infections. Pharmacies have to follow strict USP rules for this, called USP Chapter <797>, so they do not get any contamination. They use cleanrooms, special equipment, and good staff training to keep things safe.

For nonsterile compounding, like making creams or capsules, there are inspection rules and standards too in USP Chapter <795>. These rules help make sure the medication is made the right way and is not contaminated. State boards of pharmacy check these standards by doing regular inspections.

Building Trust: Key Communication and Transparency Practices

Patient intake and medication information form highlighting documentation and transparency required in reputable compounding pharmacies

Trust starts with being open. A quality compounding pharmacy will show you how it does things and will answer your questions. The compounding pharmacy should also make sure you know about its rules for quality assurance, proper documentation, and the way it talks with patients.

How Pharmacies Should Handle Recalls and Patient Communication

A pharmacy’s approach to recalls offers insight into its commitment to patient safety. Reputable pharmacies maintain clear, written procedures for handling recalls and notifying patients. Asking how recall alerts are managed helps confirm that safeguards are in place.

Also, pharmacies need to keep track of and report adverse events to the FDA and other groups that look over safety. They should talk to you about any problems as soon as they come up instead of keeping things quiet. This kind of openness from the pharmacy is very important for your safety and helps you trust them. Being clear is a big part of transparency.

Request a Consultation With Healthon

Doctor consulting overweight patient about personalized compounded medication options and the importance of choosing a trusted pharmacy

Picking the right compounding pharmacy is a big part of your healthcare, but you do not have to do it by yourself. If you want help to understand your option or if you want to know how to check if a compounding pharmacy follows the best practices, Healthon can help you.

Frequently Asked Questions

What questions should I ask a compounding pharmacy before filling a prescription?

Ask them if they are licensed and if they have a PCAB approval. You should also check if they use strong quality control steps, like if they follow USP rules. See if they do third-party checks on what they make. Ask them if they can give a Certificate of Analysis (COA) for the parts used in your prescription drug. They should be able to show their certificate when you ask.

How can I use a COA checklist when choosing a compounding pharmacy?

When you check a pharmacy, ask them for a COA for the main part in your compounded medication. This helps with quality control. It shows the ingredient is strong and pure, and it meets the needed specifications. If a pharmacy is open to give you a COA, it proves they are clear and care about transparency.

What is the difference between 503A and 503B compounding pharmacies?

503A pharmacies mix medications for a single patient when they get a prescription. Their work is watched over by state boards of pharmacy. 503B facilities make medicines in big batches. They do this even if there is no prescription. Boards of pharmacy and the FDA keep an eye on what they do. 503B places need to follow tighter oversight from the FDA. They also must meet cGMP rules.

Are there specific inspection requirements for nonsterile compounding pharmacies?

Yes. Nonsterile compounding is managed by USP Chapter <795>. State boards of pharmacy enforce these rules during their checks. The requirements include the way ingredients are chosen, how the preparation happens, and quality assurance steps. This is done to make sure the finished product is safe and right.