...Remember that you can have a 2 single-dose container or a multi-dose vial in 3 addition to.....I know in the 2 community out there the multiple dose container 3 term is used rather loosely.....So a multiple dose container has a 21 volume limit of 30 ml, but pharmacy bulk pack is 22..
http://www.fda.gov/cder/regulatory/pet/0521pet.doc (score=100)

Human Drug Notes
...Unless the multi-dose container is labeled to yield a specific number of doses of a stated.....The primary concern with multi-dose containers is the potential for contaminating the.....dose container before the drug is depleted or before the drug reaches its expiration date..
http://www.fda.gov/cder/hdn/hdn995.htm (score=52)

ENFORCEMENT REPORT FOR DECEMBER 4, 2002
...CODE 196-2-2 printed on the rim of the lid of the container. It is preceded by a four.....REASON Defective container; delivery system may dispense less than the expected amount of.....90mL) multi-dose container, Lemon Flavor, Sugar Free. Recall # D-057-3; b) Oral Saline..
http://www.fda.gov/bbs/topics/enforce/2002/ENF00772.html (score=52)

X:TRANSFERGUIDANCEFINAL 807FN1.PDF
...products needs to be evaluated over time in the same container-closure system in which the.....warning statements and unit-dose packaging for solid oral drug products that contain 30 mg.....children would be reduced significantly through the use of unit-dose packaging because..
http://www.fda.gov/cder/guidance/1807fn1.pdf (score=37)

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...Patients should also be instructed to avoid allowing the tip of the dispensing container.....There have been reports of bacterial keratitis associated with the use of multiple-dose.....continued use of the multi-dose container. Patients should be advised that if they develop any..
http://www.fda.gov/cder/foi/label/2001/21257lbl.pdf (score=37)

potassium chloride in 5% dextrose and sodium chloride injection in plastic...
...Suspend container from eyelet support. institute appropriate therapeutic countermeasures.....Remove plastic protector from outlet port at bottom of container. fluid for examination if.....The Viaflex® Plus plastic container.. supply in a single dose container for intravenous..
http://www.fda.gov/medwatch/SAFETY/2003/03APR_PI/PotassiumChlorideinD5andNaCl_0.45.pdf (score=22)

Guidance for Industry: Container Closure Systems for Packaging Human Drugs...
...This test measures the water vapor permeation of a single-unit or unit-dose container closure.....guidance document represents the Agency's current thinking on container closure systems.....container upon opening or used only when a dose is to be administered. Measuring spoons, dosing cups, measuring syringes, and vaginal..
http://www.fda.gov/cber/gdlns/cntanr.pdf (score=22)

Guidance for Industry - Container Closure Systems for Packaging Human Drugs...
...This test measures the water vapor permeation of a single-unit or unit-dose container closure.....Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.....The container should have an intrinsically low rate of water vapor permeation, and the..
http://www.fda.gov/cber/gdlns/cntanr.htm (score=22)

Container Closure Systems for Packaging Human Drugs and Biologics
...This test measures the water vapor permeation of a single-unit or unit-dose container closure.....Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.....The container should have an intrinsically low rate of water vapor permeation, and the..
http://www.fda.gov/cder/guidance/1714fnl.htm (score=22)

...20]A container closure system that is considered to control the dose delivered to the patient is a container closure system.....23]A multiple-unit container is a container that permits withdrawal of successive portions of the.....A change from a single unit dose container to a multiple dose container system. Changes that add or delete silicone..
http://www.fda.gov/cder/guidance/3516fnl.doc (score=21)

ENFORCEMENT REPORT FOR OCTOBER 9, 2002
...Tobramycin, per 30mL, Multiple Dose Vial,(40 mg/mL) traypaks of 6, Rx only, NOVAPLUS, USA.....Aunt Heddy's(R) brand Apricot Rugala, packaged in a rigid plastic container, net wt. 12 oz.....Dobutamine per 20 mL, 20 mL Single Dose Vial, Rx only, NOVAPLUS, For I.V. Use Only, USA..
http://www.fda.gov/bbs/topics/enforce/2002/ENF00764.html (score=21)

ENFORCEMENT REPORT FOR July 23, 2003
...9% Sodium Chloride Injection, USP, 100 mL, ADDS Unit Single-dose container, For I.V. use, Rx.....PlumSet, Convertible Pin, 105 Inch; u) Latex-Free Enteral PlumSet with Integral Container.....Container, Nonvented, 105 Inch, list 064920402, lots 031024W, 88046HG; v) Latex-Free..
http://www.fda.gov/bbs/topics/enforce/2003/ENF00805.html (score=21)

Changes to an Approved NDA or ANDA
...A change in the size and/or shape of a container containing the same number of dose units.....A change to a new container closure system when the container closure system is already approved in the NDA or ANDA for.....dose delivered to the patient or the formulation modifies the rate or extent of..
http://www.fda.gov/cder/guidance/2766fnl.htm (score=21)

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...20A container closure system that is considered to control the dose delivered to the patient is a container closure system.....23A multiple-unit container is a container that permits withdrawal of successive portions of the contents.....particle size) of the dose delivered to the patient, including the addition or deletion of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1999d-0529-gdl0003.pdf (score=21)

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...20A container closure system that is considered to control the dose delivered to the patient is a container closure system.....23A multiple-unit container is a container that permits withdrawal of successive portions of the contents.....particle size) of the dose delivered to the patient, including the addition or deletion of..
http://www.fda.gov/cder/guidance/3516fnl.pdf (score=21)

Enforcement Report for August 4, 2004
...Calcitriol Injection, 1 mcg/mL, 1 mL Single Dose Ampul, 10 ampuls per tray, 5 trays per.....container and the almonds are plainly visible on top of the cake. VOLUME OF PRODUCT IN.....5% Dextrose Injection, USP, 2mL ampul ‚ 5 single ampuls, Single-dose Container, NDC 0074-4712..
http://www.fda.gov/bbs/topics/enforce/2004/ENF00859.html (score=21)

Drug Approvals - A
...Aggrastat (tirofiban hydrochloride) Injection Premixed 25 mg per 500 mL single dose.....5 mg per 50 mL vial & Premixed 25 mg per 500 mL single dose container, Rx.. Merck.. NDA 20-913..
http://www.fda.gov/cder/approval/a.htm (score=21)

MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....also known as oral and nasal metered dose inhalers respectively or MDIs) and inhalation.....elastomeric, plastic components or coatings of the container and closure system when in..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=9)

MedWatch - October 2002 Safety-Related Drug Labeling Changes
...At the therapeutic dose of 400 mg, the mean change in post-dose QTc interval from baseline.....The flexible plastic container is fabricated from a specially formulated polyvinylchloride.....Water can permeate from inside the container into the overwrap but not in amounts..
http://www.fda.gov/medwatch/SAFETY/2002/oct02.htm (score=7)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...Additionally, leakage of the propellants may concentrate the contents of the container to a point where dose content.....In addition, a product filler capable of reproducing an exact fill amount from container to container.....This interaction can contribute to inconsistent dose delivery and particle size..
http://www.fda.gov/cder/fdama/difconc.htm (score=7)

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