News You Can Use: Vol. 1, No. 1: Compounding Operations - General: 795, 797, 800

March 3, 2026

This is the first of many editions of this newsletter that will systematically review all Risk-Based auditing Topics. The intent is to provide the 503A world with “tips” concerning compliance with all such Topics.

Feedback is welcome! Email: LRD@CCE-team.com

1.1 - All required quality assurance and control steps have been conducted and documented on compounding records.

Compounding records usually have a field for "Description [of final preparation]," but pharmacies often have rather "wimpy" information entered in this field.

What should appear here is every trait that the checking pharmacist expects the final preparation to have; if not present, it would be reworked or discarded.

Even if the compounding record does a good job at listing these traits, a specific verification that the final preparation actually possesses them is often lacking.

In other words, the compounding record should include something like the matrix shown below:

Table 2 of USP <1163> can provide some inspiration for what traits each such table should include - although this list is going to be pretty standard for a given dosage form: what will vary are the specific desired traits. (BTW, my suggestions here do not imply that they are required by any USP chapter unless specifically stated.)

BTW, many or even all of these traits might not be verifiable in the final container closure system, meaning that an intermediate quality control check must be inserted.

Turning to capsules, troches, suppositories, tablets, or any other compounded discrete dosage forms, pharmacies sometimes fail to properly assess weight uniformity.

Unfortunately, it is not uncommon for ten randomly selected capsules (or whatever) to be weighed as a group, and this number to be divided by ten. If the resulting number is within ± 10% of the expected weight, the batch is "passed."

The problem here is that some of these capsules could be significantly too heavy and some too light - nonetheless resulting in an acceptable average weight.

You need to weigh each of the ten capsules individually, then determine if any weigh more or less than 10% of the expected weight. USP <1163> includes detailed instructions on this, as well as what to do in the event of a failure.

An alternative approach is to determine the standard deviation of the sample and similarly determine if it is acceptably small.

Turning to sterile preparations, the desired trait list is going to be pretty standard - but the results of the final inspection must still be specifically documented, see below:

Concerning both sterile and nonsterile compounding, many pharmacies have not noticed a provision appearing in the latest revisions of USP <795> and <797>: preparations must receive a final visual inspection before release if this is not done the same day as compounded.

This inspection need not be "invasive," instead focusing on such things as absence of leaks, cracked or compromised containers, and color when applicable. It needs to include the labeling and the container in general.

Neither chapter stipulates that this must be performed by a pharmacist, meaning that adequately trained and competency-assessed supportive personnel, e.g. front-end clerks or back-end warehouse staff, may do this.

Should you document this step? It's not required or even mentioned, but not a bad idea.

A final comment about compounding records. These documents are often covered with check marks, initials, circles, hand-written numbers, and signatures. When I ask people what each of these means, I can get uncertain or even contradictory replies! SOPs simply must carefully describe what all of these marks mean, and who may make them. Your SOP should include some sample compounding records with all required “markup.”

L. Rad Dillon, R.Ph., M.A., ASQ SSGB., GMPro., FACA., ASQ CQA.

Founder, CCE: Coalition for Compounding Excellence

LRD@cce-team.com