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All Containers›Shop by use case›Compounding›What we publish›Against paragraph (d)Shop all compounding →
What we publish

Against paragraph (d)

By Dwight Davis, Founder

On this page13
Nine labels on most rows. And none of them is an acceptance criterion.

What paragraph (d) asks for

Standards or specifications, methods of testing, and where indicated methods of cleaning, sterilizing and depyrogenation, written and followed for drug product containers and closures.

What we publish

Color on all 486 rows, 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.

Which is a product description

Nine attributes, mostly complete, and useful for selecting a container. None of them is an acceptance criterion with a test method behind it.

The difference is what happens when a lot is out of tolerance

A specification says what the limit is and how it is measured. A description says what the product usually is.

Temperature range is the closest thing to a real spec

Published on 410 of 486 rows, and directly relevant to paragraph (b)'s foreseeable external factors in storage and use.

And liner is the most consequential one

350 of 486, which matters because the liner is the surface in contact and is therefore inside the reactive, additive and absorptive question.

Capacity is published on only 106 rows

Which are the containers. The closures do not have a capacity, so that number is complete rather than thin.

Recyclable on 5 rows is genuinely thin

Out of 486. Which is worth knowing if a recyclability claim is part of the product, and is not relevant to paragraph (d).

What is absent

A certificate of analysis, extractables or leachables data, methods of testing, and any cleaning, sterilization or depyrogenation method. We publish none of those and hold none.

And a lot number is not published either

Which matters for paragraph (d) in practice, because a written standard is only enforceable against identifiable material. Case pack and dc sku are what we publish per product.

Nor is a molder or a resin grade

Two polypropylene jars with the same published material can come from different resins. That is the level a container specification usually reaches and ours does not.

So paragraph (d) has to be satisfied on your side

Written standards, written methods, and whatever qualification the preparation needs. We supply attributes to write them against.

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.