What goes wrong

The table was read as a specification

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Our spec table was treated as a specification A certificate of analysis was expected So paragraph (d) was assumed to be covered Sterility was assumed to come with the container And temperature range was read as an autoclave tolerance The cGMP scope was assumed in both directions An oral liquid was planned without a dosing device And an 18DIN bottle was chosen A suppository shell was searched for The recyclable field was read as meaningful And the capacity field was read as a fill Read the four paragraphs, then ask us for attributes References

A description says what a product usually is. A specification says what the limit is.

Our spec table was treated as a specification

Color, material, case pack, neck finish, height, temperature range, liner, width, capacity. Nine attributes and no test method behind any of them.

A certificate of analysis was expected

We issue none. There is no certificate, no extractables or leachables data, and no methods of testing on our side.

So paragraph (d) was assumed to be covered

It requires written standards or specifications and methods of testing for drug product containers and closures. Those have to exist on the compounder's side.

Sterility was assumed to come with the container

Nothing in this catalog is supplied sterile or depyrogenated. That is a catalog-wide check and the answer is none.

And temperature range was read as an autoclave tolerance

It is a storage and use range, published on 410 of 486 rows. It says nothing about a sterilization cycle.

The cGMP scope was assumed in both directions

Part 211 is current good manufacturing practice for finished pharmaceuticals, and compounding under section 503A carries conditional exemptions from certain requirements including cGMP. Neither assuming it applies nor assuming it does not is safe.

An oral liquid was planned without a dosing device

No oral syringe and no bottle adapter exist in this catalog, so the system has to be completed elsewhere.

And an 18DIN bottle was chosen

8 of the containers here carry that neck, and the tinctures property measures that our catalog holds no 18DIN closure at all.

A suppository shell was searched for

It is a dosage form shipped in its own mold. A primary container catalog does not hold one.

The recyclable field was read as meaningful

It is published on 5 of the 486 rows in this group. Which is thin enough that it should not be relied on either way, and it has nothing to do with paragraph (d).

And the capacity field was read as a fill

It is a nominal container volume. What a preparation is filled to, and the surface to volume ratio that follows, is a compounding decision.

Read the four paragraphs, then ask us for attributes

We are a source of container attributes. The standards, the methods and the qualification are the compounder's, and saying so is more useful than implying otherwise.

References

The Davis Pack Supply catalog, measured 19 October 2026. Specification labels present on the 486 rows indexed to this group: Color on 486, Material on 484, Case pack on 482, Neck finish on 473, Height on 454, Temperature range on 410, Liner on 350, Width on 126, Capacity on 106, Recyclable on 5.

The Davis Pack Supply catalog, checked catalog-wide on 19 October 2026. No container or closure in this catalog is supplied sterile or depyrogenated, and we publish no sterilization or depyrogenation data. There is no oral dosing syringe and no bottle adapter anywhere in the catalog. We publish no certificate of analysis, no extractables or leachables data and no methods of testing.

21 CFR 211.94, "Drug product containers and closures". (a) "Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements." (b) "Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product." (c) "Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. Such depyrogenation processes shall be validated." (d) "Standards or specifications, methods of testing, and, where indicated, methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures." Part 211 is current good manufacturing practice for finished pharmaceuticals; compounding under section 503A of the Federal Food, Drug, and Cosmetic Act carries conditional exemptions from certain requirements including cGMP, and nothing here asserts that this section applies to any particular compounder. law.cornell.edu

Written from 21 CFR 211.94 and from the catalog as it stood on 19 October 2026. Part 211 is current good manufacturing practice for finished pharmaceuticals; compounding under section 503A of the Federal Food, Drug, and Cosmetic Act carries conditional exemptions from certain requirements including cGMP, and nothing here asserts that 211.94 applies to any particular compounder. Our chemical resistance figures are a five-point rating on a resin family, not a compatibility finding for a formulation. No container in this catalog is supplied sterile or depyrogenated, and we publish no extractables data and no certificate of analysis.