USP 795 Key Points: Compounding and Formulation records

Share This Post

The formulation record and compounding record is an easy-to-miss area of compliance, but with numerous cases of patient harm related to compounding it is critical that pharmacies, for patient safety and for their own liability, get it right.

Probably the most notable is that of the New England Compounding Center, but even more recently problems with levothyroxine compounded formulations have received public attention and scrutiny.

Are your compounding and formulation records compliant with USP 795? Without further ado, here is your crash course.

Formulation Records

We all know that formulation records are the ‘recipe’ to be followed when compounding. Everything you compound should have a formulation record, but perhaps more importantly that formulation record should be evidence-based. In the first paper I ever published in a peer-reviewed journal, I described my final-year student project to standardize formulation records at the health-system I was on rotation at.

Prior to implementation, the formulation records were on index cards in a form of a ‘recipe box,’ with handwritten notes, sometimes missing sources, and sometimes stating that the formulation record came from another hospital (pictures are in the paper).

I would argue unfortunately this situation is not uncommon, and either developing or buying evidence-based formulation records is one of the easiest things any pharmacy, community or inpatient (or other), can do to improve the safety of compounded medications.

It also provides documentation in the case there is a lawsuit; after all, would you want to be on the stand as the lawyer grills you on why you made a medicine for a patient based on a word-of-mouth recipe? I certainly don’t.

Formulation record components are regulated by USP 795, USP 797 (for sterile compounding), and state Boards of Pharmacy.

Here are the components required:

• Name, strength, and dosage form of the CSP

• Physical description of the final preparation

• Identities and amounts of all ingredients and appropriate container-closure systems

• Complete instructions for preparing the CSP, including equipment, supplies, and a description of the compounding steps

• BUD and storage requirements

• Quality control procedures (e.g., pH, filter integrity, and visual inspection)

• Sterilization method, if applicable (e.g., filter, steam, or dry heat)

• Any other information needed to describe the operation and ensure its repeatability (e.g., adjusting pH and tonicity and temperature)

So now the million-dollar question: where can I find evidence-based formulation records?

Most people who work in compounding know that PCCA is the top-notch provider of compounding resources. They sell products, but to me their biggest value is in the over 9,500 formulation records in their database and the clinical education team to help compounders solve tough problems. If you are planning on really getting into compounding it is worth considering membership. When I rotated through a PCAB accredited compounding pharmacy as a student I saw the value it provided first-hand.

Formulation Records Online

If you really only plan on compounding occasionally and feel that it is not the right choice to join PCCA, you should still get your Formulation Records together for what you do compound.

Also, as a word of caution, it is best not compound complex formulations unless you have the education and experience to do so. Compounding is a specialty and should be treated that way!

In addition, these two websites provide free recipes. The UNC website has recipes already formatted into a Formulation Record, while Secundum Artum provides the recipe with necessary stability data but unfortunately does not create a full Formulation Record.


From the UNC Eshelman School of Pharmacy. A treasure trove of information on compounding, including free formulation records.


One of the best sites to get started in compounding. Their newsletters feature great general compounding information as extensive stability data for compounded formulations using Perrigo products.

Compounding Records

USP 795 and 797 (for sterile preparations), as well as state Boards of Pharmacy (like NC and KY), regulate what components are required in a compounding record:

• Name, strength, and dosage form of the compounded sterile preparation (CSP)

• Master Formulation Record reference for the CSP, when used

• Date and time of preparation of the CSP

• Assigned internal identification number (e.g., prescription or lot number)

• Signature or initials of individuals involved in each step (e.g., technician or pharmacist)

• Name, vendor or manufacturer, lot number, and expiration date of each ingredient and container-closure system

• Weight or measurement of each ingredient

• Documentation of the calculations, made to determine and verify quantities and/or concentrations of components, if appropriate

• Documentation of quality control procedures in accordance with the SOP (e.g., filter integrity, pH, and visual inspection)

• Any deviations from the Master Formulation Record, if used, and any problems or errors experienced during the compounding of the CSP

• Total quantity compounded

• Assigned Beyond Use Date

• Duplicate container label if prepared in a batch

Many pharmacy systems can create printable compounding records from the data entered, which is easier, but in the case your system doesn’t you’ll want to get a compounding record template that has all the required information.

Healthcare Disclaimer: The information provided  on is for educational and informational purposes only and is not intended to serve as medical advice. Our tools are designed to provide general conversion estimations and should not be used as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician, pharmacist, or other qualified health provider with any questions you may have regarding a medical condition or medication. Read More in our Terms of Use.

Share This Post

Recent Articles

Share On:

More To Explore

Designing Your Pharmacy Labels for Safety and Efficiency

My guess is that you probably haven’t given much thought to your labels since your pharmacy opened. After all, it has everything on there

What to Know About CLIA Waivers and Point-of-Care-Testing

Note: This post is from 2020 and was originally on We are posting to provide you with as much information as possible on

What’s in the EPA Pharmacy Standards?

The Resource Conservation and Recovery Act (RCRA) governs the disposal of solid and hazardous waste, and under RCRA pharmacies are considered hazardous waste generators.

Pharmacogenomics in the Community Pharmacy

It’s no secret that pharmacies are going to have to diversify their revenue streams and continue to expand on non-dispensing revenue in order to

An interview with Tyler Taylor, PharmD, of St. Louis Hills Pharmacy

St. Louis Hills Pharmacy has actually implemented compostable prescription vials in their store. In addition, they have an entire page of their website dedicated

Drug Supply Chain and Security Act Infographic

This infographic is a visual representation of the post Top Things to Know About the Drug Supply Chain and Security Act (DSCSA). Get your

Optimize Your Pharmacy Software System [18 Ways]

Making the most of your computer system is one of the easiest, no-cost ways you can improve your workflow, save time, and reduce the

Hazardous Drug Handling in the Community Pharmacy

One of the most commonly overlooked areas of community pharmacies I have either managed or worked in involves the handling and dispensing of hazardous

How Does the Inventory Adjustment Work? [With Examples]

If you’re confused about the adjustment made to your income statement after inventory, you’re not alone. Here, we’ll look at …

9 Tips for Managing Controlled Substances in the Pharmacy

It’s no secret controlled substances are one of the biggest subjects of any pharmacy inspection, so if your pharmacy doesn’t have a good handle

HIPAA and Drug Reps: What Info Can I Release?

I got an interesting email recently from a pharmacist who read an article I wrote in the past for Pharmacy Times about drug reps

Responding to a State Board of Pharmacy Complaint

This article is by Jeffrey Baird, esq., a healthcare attorney who practices with Brown and Fortunato, PC. I thought it gave a great overview

Best Practices: The Compliance Binder

The Compliance Binder is a pharmacy best practice that will really make your life easier. While not legally required, the compliance binder has everything

How to Manage a Drug Recall

Systems to quickly manage recalls are an important, but often overlooked, area of pharmacy operations. This was brought to the forefront of the public’s

Maximizing Your Pharmacy Switch

Your pharmacy switch routes the claim from your pharmacy to the insurance company. Here’s what you need to know.

6 Top Tips to Know about DSCSA (Drug Supply Chain Security Act)

Here’s what you need to know about DSCSA to stay compliant and avoid fines.

3 Most Frequently Asked Questions About the 340b Program

If you’re wondering where to get started with the 340b program, this is a great place to get started.

What is a Surety Bond?

What is a surety bond? Let’s look a little more closely at why you should get one for your pharmacy.

The Ultimate Guide to DMEPOS Accreditation for Pharmacies

Need to get DMEPOS Accreditation? Here’s a step-by-step guide.

How to Read an Income Statement

If you’re new to accounting and finance, the income statement can be confusing. Here’s what to look for.

Tips to get started with pharmacy sustainability

I’m sure you can guess from the title what this post is about. Today we’re going to talk about greening the community pharmacy. Why

5 Great Pharmacy Organization Ideas

If you’ve been putting off getting your pharmacy organized, there’s never been a better time to get started. Here are a list of ideas

Tracking Licenses and Certifications

This state law also requires all pharmacy technicians to ultimately obtain certification from NCCA-accredited organizations (i.e., PTCB or NHA) after a provisional grace period.

Infographic: USP 800 Visual Guide

This one guides you through a very brief overview of each chapter of USP 800.

The 7 BEST Shoes for Pharmacy Staff [2024]

Pharmacists spend a long time on their feet, and in such a demanding environment, a good pair of shoes becomes more than just an

The Pharmacy Equipment Marketplace

This week’s Quick Tip comes from Shawn Earl, PharmD. Dr. Earl is the founder of Pinnacle Pharmacy Group and specializes in pharmacy mergers and

Are you tracking exclusions?

This Quick Tip is a reminder for pharmacies that they need to be checking all their staff at hire and at least monthly to

The Correct Medical Refrigerator Temperature Range

According to the CDC Vaccine Storage and Handling Toolkit, the correct medical refrigerator temperature range is 36-46 Fahrenheit.
error: Content is protected !!