Three words, three different things going wrong.
The clause
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.
Reactive
The container and the contents chemically attack each other. A solvent crazing a resin, an acid etching a wall, a preservative degrading a liner. The visible failure mode.
Additive
The container puts something into the product. Leachables from a resin, plasticizer, mold release, slip agent, or something from the liner adhesive.
Absorptive
The container takes something out. An active or a preservative sorbed into the wall or the liner, leaving the product under strength.
The third is the one nobody plans for
A reactive failure is visible and an additive failure shows up in testing. An absorptive failure produces a product that looks perfect and is weak.
And preservative loss is the common version
A preservative sorbed into a polyolefin wall over months leaves a product that passed release testing and no longer has the preservative system it was designed with.
The clause is qualified, which matters
Not reactive, additive or absorptive SO AS TO ALTER the listed attributes beyond the official or established requirements. Some interaction is tolerated; interaction that moves the product outside its requirements is not.
No resin is forbidden. The question is what happens between a particular formulation and a particular container over a particular shelf life.
Which is why a catalog rating cannot answer it
Our Chemical Resistance figure is 4 or 5 out of 5 on a resin family. The clause asks about a pairing and a duration.
The answer comes from a study
Fill the actual container with the actual formulation, store it, and assay. There is no shortcut and a catalog is not one.
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.eduThe Davis Pack Supply catalog, measured 19 October 2026. Our published material properties are a five-point rating on five attributes, per material class rather than per product: Chemical Resistance, Clarity, Impact Resistance, Rigidity and Scratch Resistance. For the two materials on this shelf, glass is rated Chemical Resistance 5 of 5, Clarity 5, Rigidity 5, Scratch Resistance 5 and Impact Resistance 1; polypropylene is rated Chemical Resistance 4, Clarity 5, Rigidity 5, Scratch Resistance 5 and Impact Resistance 4. Ten material classes are rated in total. These are a screening tool on a resin family and not a compatibility finding for a formulation.
