When a labeling exemption runs out

Why some containers say almost nothing

Drug labeling law generally requires adequate directions for use. A short list of situations is exempted, and each one describes a container that is not going to a patient yet.

A companion piece here covers two of them in detail: material shipped for processing or repacking, and drugs supplied for teaching, law enforcement, research and analysis. This one is about what happens at the other end.

Every one of those exemptions has a stopping point. Section 201.127 is where the stopping points are written, and it is short enough to read in full.

Its practical importance is that an exemption is not a property of a substance. It is a property of a shipment, a purpose and a possessor, and any of the three can change.

The exemption expires when the shipment leaves its purpose

Paragraph (a) of section 201.127 states the rule, and the timing in it is unusual.

Where a shipment of an exempt drug is made "to a person in whose possession the article is not exempt, or is made for any purpose other than those specified," the exemption expires.

It does not expire on arrival. The exemption "shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery."

And the consequence is named. Causing an exemption to expire "shall be considered an act which results in such drug being misbranded unless it is disposed of under circumstances in which it ceases to be a drug or device."

Read together, that means the moment the wrong shipment starts, the article was already misbranded when it started. There is no window in which it was in transit and still fine.

Otherwise, it lasts until the drug is used or relabeled

Paragraph (b) covers the ordinary case, where nothing goes wrong.

The exemptions conferred by the named sections "shall continue until the drugs are used for the purposes for which they are exempted, or until they are relabeled to comply" with the adequate directions requirement.

So the exemption ends at consumption or at relabeling, whichever comes first. Both are events, not dates.

There is a further step for anything that becomes a dosage form. If the drug "is converted, compounded, or manufactured into a dosage form limited to prescription dispensing, no exemption shall thereafter apply" unless the dosage form carries prescription labeling.

That sentence is the bridge between a bulk container and a dispensed one. The moment raw material becomes a prescription dosage form, the bulk exemptions stop being available to it.

The exemption for prescription chemicals

Section 201.120 covers a category that reads directly onto how compounding material moves. It applies to a drug "prepared, packaged, and primarily sold as a prescription chemical or other component for use by registered pharmacists in compounding prescriptions."

It attaches conditions, and they are cumulative. The first is a physical form test: the drug must be an official liquid acid or alkali, "or is not a liquid solution, emulsion, suspension, tablet, capsule, or other dosage unit form."

The second is a required label statement, prescribed word for word. The label must bear a statement that the regulation prints in quotation marks: For prescription compounding.

A second statement depends on the substance. Where it is subject to the prescription-only provision in substantially all dosage forms in which it may be dispensed, the label must also bear a second prescribed statement: Rx only.

And there is a stop that mirrors the one in the neighboring sections. The exemption "shall not apply to any substance intended for use in compounding which results in a new drug, unless an approved new-drug application covers such use."

The quiet exemption for inactive ingredients

Section 201.117 is one sentence and covers material almost nobody thinks about.

A harmless drug "ordinarily used as an inactive ingredient, such as a coloring, emulsifier, excipient, flavoring, lubricant, preservative, or solvent, in the preparation of other drugs" is exempt from the adequate directions requirement.

The same limit applies here as everywhere in this family. The exemption "shall not apply to any substance intended for a use which results in the preparation of a new drug, unless an approved new-drug application provides for such use."

The list in that sentence is worth keeping. Coloring, emulsifier, excipient, flavoring, lubricant, preservative, solvent. Those are the categories a formulation is built out of besides the active substance, and a separate piece here covers what they do in an injectable.

The repacking exemption, and the agreement behind it

Section 201.150 covers a shipment sent to be processed, labeled or repacked at a different establishment. Its structure is different from the others, and the difference is instructive.

Where the shipper is not the operator of the receiving establishment, the exemption depends on a written agreement, "signed by and containing the post-office addresses of such person and such operator."

That agreement has to do real work. It must contain "such specifications for the processing, labeling, or repacking, as the case may be, of such drug in such establishment." Those specifications must be enough that, if followed, "such drug will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking."

Both sides keep a copy "until 2 years after the final shipment or delivery of such drug from such establishment," and must make it available for inspection "at any reasonable hour" to a requesting official.

Refusing to produce it is itself a trigger. The exemption becomes void or expires on a refusal by either the shipper or the operator to make a copy available.

Void ab initio, and why the phrase matters

Section 201.150 uses a phrase the other sections do not, and it has a specific effect.

One case turns on who ships. Where the shipper operates the receiving establishment, the exemption "shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment, become void ab initio." The condition is that "the drug comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed."

Void ab initio means void from the beginning. Not ended, not lapsed, but treated as never having applied.

The practical consequence is that a problem discovered at the end of a repacking operation reaches backwards over the whole time the material sat there. It does not merely change the status of the goods going forward.

The same section also uses ordinary expiry language for the other route, so both mechanisms appear side by side in one place, which is a useful thing for a reader to see.

What this is good for, and what it is not

Three things follow that a reader can actually use.

A container with almost nothing on it is not evidence of anything by itself. Several exemptions permit exactly that, each with its own prescribed wording, and one of them requires the words For prescription compounding to appear.

An exemption is tied to a purpose and a possessor. The same material in a pharmacy and the same material sent somewhere it should not be are in different legal positions, and the second one was misbranded from the moment the shipment began.

And an exemption stops at the dosage form. Once material is compounded into something limited to prescription dispensing, the bulk exemptions are gone.

What this page does not do is read a statute. The underlying statutory provisions these exemptions run from were not pulled for this piece, so it describes what the regulations say and not what the Act says. It names no seller, assesses nobody's compliance, and is not legal advice.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. Title 21 Code of Federal Regulations section 201.127, Drugs; expiration of exemptions — Electronic Code of Federal Regulations, Office of the Federal Register, February 1976
2. Title 21 Code of Federal Regulations section 201.117, Inactive ingredients — Electronic Code of Federal Regulations, Office of the Federal Register, March 1975
3. Title 21 Code of Federal Regulations section 201.120, Prescription chemicals and other prescription components — Electronic Code of Federal Regulations, Office of the Federal Register, February 2002
4. Title 21 Code of Federal Regulations section 201.150, Drugs; processing, labeling, or repacking — Electronic Code of Federal Regulations, Office of the Federal Register, January 1999