Packaging system (also referred to as a Container–closure system): The sum of Packaging components and materials that together contain and protect the article. This includes Primary packaging components as well as Secondary packaging components when such components are required to provide additional protection.
Container: A receptacle that holds an intermediate compound, API, excipient, or dosage form, and is in direct contact with the article (e.g., ampules, vials, bottles, syringes, and pen injectors).
Closure: A material that seals an otherwise open space of a Container and provides protection for the contents. It also provides access to the contents of the Container (e.g., screw caps and stoppers).
Packaging component: Any single part of the Package or Container–closure system, including the
- Container (e.g., ampules, syringes, vials, and bottles);
- Closures (e.g., screw caps and stoppers);
- ferrules and overseas;
- Closure liners (e.g., tube cartridge liners);
- inner seals;
- administration ports;
- overwraps;
- administration accessories;
- labels;
- cardboard boxes; and
- shrink wrap.
Primary packaging component: A Packaging component that is in direct contact with or may come into direct contact with the article.
Secondary packaging component: A Packaging component that is in direct contact with a Primary packaging component and may provide additional protection for the article.
Tertiary packaging component: A Packaging component that is in direct contact with a Secondary packaging component and may provide additional protection for the article during transportation and/or storage.
Ancillary component: A component or entity that may come into contact with a Tertiary packaging component during the distribution, storage, and/or transportation of the packaged article (e.g., pallets, skids, and shrink wrap).
Associated component: A Packaging component that is typically intended to deliver the drug article to the patient but is not stored in contact with the article for its entire shelf life (e.g., spoons, Dosing cups, and dosing syringes).
Materials of construction: The materials (e.g., glass, plastic, elastomers, and metal) of which a Packaging component consists.
Small-volume injection (Small-volume parenteral): An injectable dosage form that is packaged in Containers labeled as containing 100 mL or less.
Large-volume injection (Large-volume parenteral): An injectable dosage form that is packaged in Containers labeled as containing more than 100 mL.
Child-resistant packaging: A Packaging system designed or constructed to meet CPSC standards for opening by children.
Senior-friendly packaging: A Packaging system designed or constructed to meet CPSC standards for opening by senior adults.
Restricted delivery system: A Packaging system designed or constructed to restrict (control) the amount of the drug product that may be delivered to limit unintended access by children and other similarly vulnerable populations. Restricted delivery systems should meet and may exceed CPSC standards for special packaging.
For oral medicinal liquids, surface and flow characteristics vary. It is the responsibility of the manufacturer to ensure that all components of the Restricted delivery system provide the intended safety protection. One component of the Restricted delivery system is the flow restrictor, which is a Packaging component that restricts the flow of liquid.
The flow restrictor may be used as part of a Restricted delivery system or as an adaptor to facilitate the use of a measuring device for oral medicinal liquids. A flow restrictor should not compromise CPSC standards for special packaging.
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Tamper-evident packaging: A Packaging system that may not be accessed without obvious destruction of the seal or some portion of the Packaging system. Tamper-evident packaging must be used for sterile drug products intended for ophthalmic or otic use, except where extemporaneously compounded for immediate dispensing on prescription.
Drug products intended for sale without prescription are also required to comply with the Tamper-evident packaging and labeling requirements of the Food and Drug Administration (FDA) where applicable.
Preferably, the immediate Container and/or the outer Container or protective packaging used by a manufacturer or distributor for all dosage forms that are not specifically exempt is designed to show evidence of any tampering with the contents.
Reclosable packaging: A package that after it has been initially opened is capable of being reclosed with a similar degree of security and is capable of being used a sufficient number of times to dispense the total contents without loss of security. Re- closable packaging may incorporate child-resistance capabilities.
Non-reclosable packaging: A package or part of a package that cannot be closed again after all or part of the contents have been removed. Examples of Non-reclosable packaging are blisters, sachets, strips, and other Single-unit containers.
Non-reclosable packaging may include cold-formed foil blisters, foil strip packs, and PVC/Aclar combining multilayer materials that are thermo-formed or cold-formed foil blisters. Non-reclosable packaging may be child-resistant depending on the intended use and place of use. Household non-reclosables are subject to the PPPA.
Hermetic container: A Container–closure system that is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution.
Tight container: A Container–closure system that protects the contents from contamination by extraneous liquids, solids, or vapors; from loss of the article; and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution, and is capable of tight reclosure.
Where a tight container is specified, it may be replaced by a hermetic container for a single dose of an article.
[NOTE—Where packaging and storage in a tight container or well-closed container is specified in the individual monograph, the container used for an article when dispensed on prescription meets the requirements in Containers—Performance Testing.]
Well-closed container: A Container–closure system that protects the contents from contamination by extraneous solids and from loss of the article under the ordinary or customary conditions of handling, shipment, storage, and distribution.
Light-resistant container: A Container–closure system that protects the contents from the effects of light by the specific properties of the material of which it is composed, including any coating applied to it. A clear and colorless or a translucent container may be made light-resistant using an opaque covering or by use of secondary packaging, in which case the label of the container bears a statement that the opaque covering or secondary packaging is needed until the articles are to be used or administered. Where it is directed to “protect from light” in an individual monograph, preservation in a light-resistant container is intended.
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Equivalent container–closure system: A Container–closure system that is as protective as or more protective than the original manufacturer’s Packaging system in terms of moisture-vapor transmission rate, oxygen transmission, light transmission, and compatibility. System equivalency extends to any special protective materials, such as those for seals or desiccants associated with the original packaging system.
Injection versus Noninjection
Injection | Non-injection |
Multiple-dose | Multiple-unit |
Single-dose | Single-unit |
— | Unit-dose |
— | Unit-of-use |
Pharmacy bulk package | — |
Imaging bulk package | — |
Multiple-dose container: A Container–closure system that holds a sterile medication for parenteral administration (injection or infusion) that has met antimicrobial effectiveness testing requirements, or is excluded from such testing requirements by FDA regulation. A Multiple-dose container is intended to contain more than one dose of a drug product. When space permits, a Multiple-dose container is labeled as such.
Multiple-dose containers are generally expected to contain 30mL or less of medications. The beyond-use date for an opened or entered (e.g., needle-punctured) Multiple-dose container is 28 days unless otherwise specified by the manufacturer on the label. An example of a Multiple-dose container is a vial.
Single-dose container: A Container–closure system that holds a sterile medication for parenteral administration (injection or infusion) that is not required to meet the antimicrobial effectiveness testing requirements. A Single-dose container is designed for use with a single patient as a single injection/infusion. When space permits, a Single-dose container is labeled as such and should include on the label appropriate discard statements. Examples of Single-dose containers are vials, ampules, and prefilled syringes.
Pharmacy bulk package: A Container–closure system of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes.
The Closure must be penetrated only one time after constitution, if necessary, with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. The Pharmacy bulk package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean-air compounding area). Designation as a Pharmacy bulk package is limited to injection.
Pharmacy bulk packages, although containing more than one single dose, are exempt from the Multiple-dose container volume limit of 30 mL and the requirement that they contain a substance or suitable mixture of substances to prevent the growth of microorganisms.
Imaging bulk package: A container of sterile preparation for parenteral use that contains many single doses of a contrast agent (medical imaging drug product) for use with a medical imaging device. The contents are restricted to use in direct conjunction with a device with features to mitigate the risk of cross-contamination (i.e., an automated contrast injection system or contrast management system approved or cleared for use with an Imaging bulk package).
The sterility assurance of the Imaging bulk package contents in part is dependent upon the automated contrast injection system or the contrast management system.
The Imaging bulk package is to be used only in a room designated for radiological procedures that involve intravascular administration of a contrast agent. Using an aseptic technique, the Imaging bulk package closure must be penetrated only one time with a suitable sterile component of the automated contrast injection system or contrast management system.
If the integrity of the Imaging bulk package and the delivery system cannot be assured through direct continuous supervision, the Imaging bulk package and all associated disposables for the automated contrast injection system or contrast management system should be discarded.
Designation as an Imaging bulk package is limited to injection, for injection, or injectable emulsion dosage forms. Imaging bulk packages, although containing more than one single dose, are exempt from the multiple-dose container volume limit of 30 mL. The contents of the Imaging bulk package must have demonstrated the ability to limit the growth of microorganisms over the labeled period of use.
Where a container is offered as an Imaging bulk package, the label must
- state prominently “Imaging Bulk Package” and, in juxtaposition with this statement, include the following use statement: “For use only with an automated contrast injection system or contrast management system approved or cleared for use with this contrast agent in this Imaging Bulk Package”;
- bear a statement limiting the time frame in which the container may be used once it has been entered, provided it is held under the labeled storage conditions; and
- bear the statement, “See drug and device labeling for information on devices indicated for use with this Imaging Bulk Package and techniques to help assure safe use”.
Non-injection Packaging Systems
Multiple-unit container: A Container–closure system that permits withdrawal of successive portions of a non-injection article without changing the safety, strength, quality, or purity of the remaining portion (e.g., bottle of capsules, tablets, and oral or topical liquids).
Single-unit container: A Container–closure system that holds a quantity of a non-injection article intended for administration as a single dose or a single finished device intended for use promptly after the Packaging system is opened.
Unit-dose container: A single-unit Container–closure system for an article intended for administration by other than the parenteral route as a single dose.
Unit-of-use container: A Container–closure system that contains a specific quantity of an article that is intended to be dispensed as such without further modification except for the addition of appropriate labeling. It is not permitted to repackage Unit-of-use containers for sale.
Miscellaneous
Repackaging: The act of removing a drug product from the original manufacturer’s Packaging system and placing it into another Packaging system, usually one of a smaller size.
Repackager: A firm that repackages drug products or medical devices for distribution (e.g., for resale to distributors, hospitals, or pharmacies). For drug products, this applies to a function that is beyond the regular practice of a pharmacy. The distribution is not patient-specific, in that there are no prescriptions. Repackagers and relabelers of medical devices are also required to register and list and meet the provisions.
Contract packager/contract repackager: A firm that is contracted by another organization, such as a manufacturer, to package bulk into a marketed Container of a drug product. A Contract packager does not take ownership from the manufacturer and generally receives the assigned expiration date from the manufacturer.
Dispenser: A licensed or registered practitioner who is legally responsible for providing the patient with a preparation that is in compliance with a prescription or a medication order and contains a specific patient label. In addition, dispensers may prepare limited quantities in anticipation of a prescription or medication order from a physician. Dispensers are governed by the board of pharmacy of the individual state. The terms “dispenser” and “pharmacy” are used interchangeably.
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