Subject: packages
From: Uka <[email-masked]>
To: Ketevan Tatoshvili <[email-masked]>, Alexander Turdziladze <[email-masked]>, Alexander Nodia <[email-masked]>, Tamta Kobakhidze <[email-masked]>
Date: Mon, 18 Jun 2012 10:50:03 +0000

შეფუთვები თავისი დეფინიციებით.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/DataStandardsManualmonographs/ucm071748.htm

imeilshic aris gadmoopirebuli.

Package Type

FDA Data Element Number.

CDER Data Element Number.  C-DRG-00907

Data Element Name.  Package Type

Data Element OID: 2.16.840.1.113883.3.26.1.1.3
Data Element NCI Concept ID: C43164

Version Number.  003

Description.  This standard provides for all types of packages that bulk drug substances and final drug dosage forms are contained in, including both the immediate (or primary) and secondary containers.

Source.  Drug registration and Listing System

Relationship.  C-DRG-00201 is for drug dosage forms.

FDA Specifications.  None.

CDER Specifications.  Package Type (abbreviated as DRLS_PKG_TYPE in the MIS reference table) shall consist of an alphabetic term which has a maximum length restricted to 240 characters, with the comma and hyphen being the only punctuation permissible.  FDA Codes representing these package types shall consist of a maximum of eight letters.  SPL shall use the NCI Concept ID as its code.

All package types shall comply with any applicable 21 CFR regulations, CDER guidances, and compendial monographs.  The container is that which holds the article and is or may be in direct contact with the article. The immediate container is that which is in direct contact with the article at all times. The closure is a part of the container.

FDA Approved Date.

CDER Approved Date.  March 9. 1998

FDA Revised Date.

CDER Revised Date.  July 26, 1999, January 11, 2006; January 25, 2006

Data Values.  See next page.

NAME

DEFINITION

FDA CODE

NCI
CONCEPT ID

AMPULE

A container capable of being hermetically sealed, intended to hold sterile materials.

AMP

C43165

APPLICATOR

A pre‑filled non‑injectable pipette, syringe or tube.

AP

C43166

BAG

A sac or pouch.

BAG

C43167

BLISTER PACK

A package that consists of molded plastic or laminate that has indentations (viewed as “blisters” when flipped) into which a dosage form, is placed.  A covering, usually of  laminated material, is then sealed to the molded part.  A strip pack is a specialized type of blister pack where there are no pre-formed or molded parts; in this case there are two flexible layers that are sealed with the dosage form in between.  Suppositories that are strip packed between two layers of foil are also considered a blister pack.

BLPK

C43168

BOTTLE

A vessel with a narrow neck designed to accept a specific closure.

BOT

C43169

BOTTLE, WITH APPLICATOR

A bottle which includes a device for applying its contents.

BOTAP

C43177

BOTTLE, DISPENSING

A bottle that is used by the pharmacist to dispense the prescribed medication.  It includes preparations for which a dropper accompanies the bottle.

BOTDIS

C43170

BOTTLE, DROPPER

A bottle that has a device specifically intended for the application of a liquid in a drop by drop manner, or a device intended for the delivery of an exact dose (e.g., calibrated dropper for oral medications).

BOTDR

C43171

BOTTLE, GLASS

A glass vessel with a narrow neck designed to accept a specific closure.

BOTGL

C43172

BOTTLE, PLASTIC

A plastic vessel with a narrow neck designed to accept a specific closure.

BOTPL

C43173

BOTTLE, PUMP

A bottle that is fitted with a pumping mechanism for the administration of drug product.

BOTPU

C43174

BOTTLE, SPRAY

A bottle that is fitted with an atomizer or a device which produces finely divided liquid carried by air.

BOTSPR

C43175

BOTTLE, UNIT-DOSE

A bottle that contains a single whole dose of a non-parenteral drug product.

BOTUD

C43176

BOX

A square or rectangular vessel, usually made of cardboard or plastic.

BOX

C43178

BOX, UNIT-DOSE

A box that contains a single dose of a non-parenteral drug product. [Note: Boxes that contain 100 unit dose blister packs should be classified under blister pack, since this is the immediate container into which the dosage form is placed.]

BOXUD

C43179

CAN

A cylindrical vessel, usually made of metal.

CAN

C43180

CANISTER

A type of can for holding a drug product.

CSTR

C43181

CARTON

A cardboard box or container which is usually considered a secondary packaging component.

CRTN

C43182

CARTRIDGE

A container consisting of a cylinder with a septum at one end, and a seal at the other end, which is inserted into a device to form a syringe which contains a single dose of a parenteral drug product.

CTG

C43183

CASE

A receptacle for holding something (e.g., that into which some oral contraceptive blister packs are placed).

CASE

C43184

CELLO PACK

A plastic "clamshell" [thin plastic pre‑formed structure for a device].

CELLO

C43185

CONTAINER

A receptacle designed to hold a specific dosage form.

CTR

C43186

CUP

A bowl-shaped container.

CUP

C43187

CUP, UNIT-DOSE

A cup intended to hold a single dose of a non-parenteral drug product.

CUPUD

C43188

CYLINDER

A container designed specifically to hold gases.

CYL

C43189

DEWAR

A container, usually made of glass or metal, that has at least two walls with the space between each wall evacuated so as to prevent the transfer of heat.  The inside of the container often has a coating (as silvering) on the inside to reduce heat transfer, and is used especially for storing liquified gases or for experiments at low temperatures.  The size can vary from that of a small thermos bottle up to that which may be mounted upon a large truck (also known as a “cryogenic truck”).

DEW

C43190

DIALPACK

A dose pack container designed to assist with patient compliance.  The patient turns a dial to the correct day and the correct dose is made available and the container indicates that the dose has been removed.

DLPK

C43191

DOSE PACK

A container in which a preselected dose or dose regimen of the medication is placed.

DSPK

C43192

DRUM

A straight‑sided cylindrical shipping container with flat ends; one of which can be opened/closed.

DRUM

C43193

INHALER

A device by means of which a medicinal product can be administered by inspiration through the nose or the mouth.

INHL

C16738

INHALER, REFILL

A container of medication intended to refill an inhaler.

INHLRE

C43194

JAR

A rigid container having a wide mouth and often no neck which typically holds solid or semisolid drug products.

JAR

C43195

JUG

A large, deep container that has a narrow mouth, is typically fitted with a handle, and is used to hold liquids.

JUG

C43196

KIT

A package which includes a container of drug product(s) and the equipment and supplies used with it.

KIT

C43197

NOT STATED

The package type is not stated or is unavailable.

NS

C48626

PACKAGE

The drug product container with any accompanying materials or components.  This may include the protective packaging, labeling, administration devices, etc.

PKG

C43233

PACKAGE, COMBINATION

A package in which two or more drug products that are normally available separately are now available together.

PKGCOM

C43198

PACKET

An envelope into which only one dose of a drug product, usually in the form of granules or powder, has been directly placed.  An example includes glassine powder paper containing aspirin.  Other examples include aluminum foil packets into which alcohol swabs and pledgets are placed.

PKT

C43199

POUCH

A flexible container used to protect or hold one or more doses of a drug product (e.g. a pouch into which oral contraceptive blister packs are inserted, and an overwrap pouch for large volume parenterals).

POU

C43200

SUPERSACK

A multilayer paper bag for shipping some solid bulk excipients, usually in the form of powder or granules.

SUPSACK

C43201

SYRINGE

A device for the administration of parenteral drug products that consists of a rigid barrel fitted with septum with a plunger at one end and a seal or needle at the other end.  The needle assembly may be part of the device or separate.

SYR

C43202

SYRINGE, GLASS

A device for the administration of parenteral drug products that consists of a rigid glass barrel fitted with septum with a plunger at one end and a seal or needle at the other end.  The needle assembly may be part of the device or separate.

SYRGL

C43203

SYRINGE, PLASTIC

A device for the administration of parenteral drug products that consists of a rigid plastic barrel fitted with septum with a plunger at one end and a seal or needle at the other end.  The needle assembly may be part of the device or separate.

SYRPL

C43204

TABMINDER

A specialized package; it registers each time it is opened and is used for checking patient compliance to prescribed medication regimens.

TABMIND

C43205

TANK

A large receptacle used for holding, transporting, or storing liquids or gases, and often referred to as a reservoir.

TANK

C43206

TRAY

A shallow flat receptacle, with a raised edge or rim, used for carrying, holding, or displaying finished drug product in its primary or market package.  A tray and its contents may be encased in shrink-wrapped plastic for shipping, or with a cover or an overwrap as part of a unit of use package or kit.

TRAY

C53438

TUBE

A flexible container for semisolid drug products which is flattened and crimped or sealed at one end and has a reclosable opening at the other.

TUBE

C42794

TUBE, WITH APPLICATOR

A tube which is provided with a device (the applicator) for administering the dosage form.  The applicator may be part of the tube closure or be separate.

TUBEAP

C43207

VIAL

A container designed for use with parenteral drug products.

VIAL

C43226

VIAL, DISPENSING

A vial that is used by the pharmacist to dispense the prescribed medication.

VIALDIS

C43208

VIAL, GLASS

A glass container designed for use with parenteral drug products.

VIALGL

C43209

VIAL, MULTI-DOSE

A vial intended to contain more than one dose of the drug product.

VIALMD

C43210

VIAL, PATENT DELIVERY SYSTEM

A vial that has a patented delivery system.

VIALPAT

C43211

VIAL, PHARMACY BULK PACKAGE

A container of a sterile preparation whose 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.

VIALPHR

C43212

VIAL, PIGGYBACK

A vial that contains a parenteral preparation that can be attached directly to the tubing of a parenterally administered fluid.

VIALPIG

C43213

VIAL, PLASTIC

A plastic container designed for use with parenteral drug products.

VIALPL

C43214

VIAL, SINGLE-DOSE

A vial containing a single unit of a parenteral drug product.

VIALSD

C43215

VIAL, SINGLE-USE

A vial where a single dose of a parenteral drug product can be removed, and then the vial and its remaining contents can be disposed.

VIALSU

C43216