The display of written, printed or graphic matter on the Immediate container of the excipient (inactive ingredient) product. [7]


The process of applying the correct label to the container following completion of line-clearance.


All written, printed or graphic matter accompanying an excipient at any time while it is in-transit to the customer or being held for sale after shipment or delivery to the customer. [7]

Large-volume Parenterals

Sterile solutions intended for parenteral application with a volume of 100ml or more in one container of the finished dosage form. [20]

Letter of Access

A written statement by the CEP holder permitting a customer to refer to the CEP information in a Marketing Authorization application.

Letter of Authorization

A written statement by the holder or designated agent or representative permitting FDA to refer to information in the DMF in support of another company's submission. [7]


All phases in the life of a product from the initial development through marketing until the product's discontinuation. [9]


An agent with a strong affinity to a metal ion. [15]


The linearity of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample. [14]


Lowest-Observed Effect Level

Long Term Testing

Stability studies under the recommended storage condition for the re-test period or shelf life proposed (or approved) for labeling. [13]


A batch or a specific identified portion of a batch. (see "Batch")

Lot Number

See "Batch Number"

Low- to medium-shear Process

The limits within which a tool or process operates based upon minimum variability as governed by the prevailing circumctances. [31]

Lowest-Observed Effect Level (LOEL)

The lowest dose of substance in a study or group of studies that produces biologically significant increases in frequency or severity of any effects in the exposed humans or animals. [16]