OTC drug product, retail sale, public access.
The section was applied to a household cache
It reaches an OTC human drug product packaged for retail sale and accessible to the public while held for sale. A household cache is none of those.
Or to a hygiene kit
Which is not a drug product, so part 211 does not reach it at all.
Or to a water purification product
Which may be a pesticide or a device rather than a drug. The camping property covers that line and this one does not.
And a first aid kit was treated as a single product
It is an assembly of items, some of which may be drug products in their own packaging. The section addresses a package, not a collection.
The exemptions in the section were not read
There are further paragraphs beyond (b) and (c), including exemptions, and this property does not set them out. Anyone relying on the section needs all of it.
cGMP was assumed to apply or not apply wholesale
Part 211 is current good manufacturing practice, and whether it reaches a given activity is a determination. The compounding property makes the same point about 211.94.
And the case pack was discovered last
Case packs here run 270 to 2,178 with a median of 410, which is the highest floor in this library and a poor fit for a household quantity.
Full case only was confused with case size
Only 8 of 94 are flagged full case only. The case figure is large and most of the shelf can be bought in smaller quantity.
Amber was skipped for a long-term store
25 amber and 3 dark amber against 24 clear. For medication held for years, that is the choice the shelf makes easy.
And the statement was assumed to be optional
It is not. Paragraph (c) requires it wherever paragraph (b) applies, and it has three conditions of its own.
Read the conditions, then take the mechanism
The requirement may not reach you and the reasoning about indicators, barriers and distinctiveness is worth having either way.
References
21 CFR 211.132(b)(1): "A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred." The same paragraph requires the packaging to be "distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture)", with distinctive by design meaning packaging that "cannot be duplicated with commonly available materials or through commonly available processes." The section reaches an over-the-counter human drug product packaged for retail sale and accessible to the public while held for sale, and nothing here asserts it binds any particular activity.
law.cornell.eduThe Davis Pack Supply catalog, measured 19 October 2026. Case packs on this shelf run from 270 to 2,178 with a median of 410, so the smallest case pack available is 270 units, which is the highest minimum measured on any shelf in this library. Only 8 of the 94 containers are flagged full case only, so most can be bought in smaller quantity; 73 are flagged available and 22 are quote only.
The Davis Pack Supply catalog, measured 19 October 2026. 222 rows: 94 containers and 128 closures, which are the same rows the travel medication and supplement group returns. 15 to 250 mL with a median of 150; 81 over an ounce, 63 over 4 oz, 11 over 8 oz, and commonest at 16 containers of 150 mL, 11 of 250, 9 each of 30 and 200, 8 of 100. 84 PET and 10 PP, with no glass. 61 PET packer bottles, 9 PET single wall jars, 5 PP single wall jars, 4 HDPE packer bottles, 4 PP round tubs, 3 honey containers. 25 amber, 24 clear, 16 white, 8 blue, 7 green, 6 natural, 5 black, 3 dark amber. Necks: 54 at 38-400, 16 at 45-400, 9 at 33-400, 4 at 43-400, 7 unrecorded. Height is published on 93 containers at 1.33 to 5.43 inches and diameter on 89 at 1.12 to 4.5. Closures: 77 continuous thread polypropylene lids, 18 CT CRC, 14 metal or aluminum CT caps, 6 round tub lids, 5 PS CT lids, 2 PS dome lids, 2 PP dome lids, 2 dairy lids, 1 plug seal lid.
