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A regulation about containers

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Every other spine in this library is about something else This one is about the container Paragraph (a) is the chemistry Paragraph (b) is the physics Paragraph (c) is the cleanliness Paragraph (d) is the paperwork Which gives a packaging catalog a scorecard The short version of our answers And the scope note belongs here, not in a footnote So this is quoted as the clearest statement, not as the rule for you References

"Drug product containers and closures." That is the whole title.

Every other spine in this library is about something else

A label, a serving, a quantity, a mark, a definition. The container is reached sideways, as the thing that happens to hold a regulated product.

This one is about the container

Four paragraphs, all of them addressed to containers and closures, and all four quoted on these pages because all four are short and load-bearing.

Paragraph (a) is the chemistry

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.

Paragraph (b) is the physics

Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination.

Paragraph (c) is the cleanliness

Clean, and where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties, with the depyrogenation validated.

Paragraph (d) is the paperwork

Standards or specifications, methods of testing, and where indicated methods of cleaning, sterilizing and depyrogenation shall be written and followed.

Which gives a packaging catalog a scorecard

Four requirements about the thing we sell, and an honest answer available for each. That is what the rest of this property does.

The short version of our answers

On (a) we publish a five-point rating on a resin family. On (b) we publish a temperature range on most rows. On (c) we have nothing at all. On (d) we publish a spec table rather than a specification.

And the scope note belongs here, not in a footnote

Part 211 is current good manufacturing practice for finished pharmaceuticals. Compounding under section 503A carries conditional exemptions from certain requirements including cGMP.

So this is quoted as the clearest statement, not as the rule for you

Whether it applies to a particular compounder is a determination this property does not make. What a container must not do is worth knowing either way.

References

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

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.

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.