Conditional on the label
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What the exemption is from
The requirements of section 352 of the title, which is the misbranding section. Those requirements are not set out on these pages.
With stated exceptions
The paragraph preserves certain requirements rather than exempting a dispensed drug from all of section 352. Which ones is in the statute.
And the whole thing turns on one word
If. Exempt from the requirements of section 352 if the drug bears a label containing the five items.
So the simplified label is a trade
A dispensed drug does not carry everything a packaged drug would, and in exchange it carries the five items that identify the dispensing.
Which is a coherent scheme
A patient does not need a manufacturer's full labeling on a bottle of thirty tablets. They need to know who filled it, who ordered it and what to do.
And it only works while the label is attached
Which is the container consequence. The exemption is available because of something printed on a specific container.
The exclusions narrow it further
Drugs dispensed through mail-order diagnosis and drugs dispensed in violation of the prescription requirements are outside the exemption, described here rather than quoted.
So there are three layers in one paragraph
An exemption, a condition the label has to meet, and exclusions that take it away regardless.
Which is why summaries of it are usually wrong
A conditional exemption with exclusions collapses badly into a sentence. The text is quoted so the layers survive.
The same shape appears across this library
The reloading property finds an exemption from a licensing scheme that is not a safety finding. The adjacent botanicals property finds a gate with two routes through it.
Here the condition is physical
A label on a container. Which is the only one of the three that a packaging decision can disturb.
And it is disturbed by the simplest possible act
Moving the tablets. No tool, no intent, no modification of the product.