Labels

FDA Drug Product Labels: PACKAGING and LABELING CONTROL Sections 211.122, 125, & 130Drug product labels for high pressure oxygen cylinders

A firm must establish written labeling procedures covering the receipt, identification, storage, handling and examination of all labeling.  Procedures should cover the reconciliation, issuance, returns, and security of labeling.  There must be written procedures to assure that the correct label is used on the drug product, including the identification of each batch with a lot number.

All high pressure cylinders, large cryogenic vessels and cryogenic home vessels are required to bear an adequate drug product label.  This label is usually the responsibility of the manufacturer, filler, transfiller, etc.
There can be only one drug label on a high pressure cylinder or cryogenic vessel, and that label is usually applied by the manufacturer, filler, transfiller, etc. of the drug product.  Cryogenic home vessels come from the manufacturer with a DEVICE label, which should not be confused with the required drug label.  Further, the device label must not be removed.  Cylinders owned by one company, but filled by another company may bear a small ownership or possession sticker in addition to the drug product label.

Upon receipt from the printer, a new batch of labels must be counted to verify the quantity of labels received, and they should be examined and compared against the approved master label to assure correctness.

If a firm uses a small, grocery-store type sticker to contain an expiration date or a lot number, then this practice should be addressed in a firm’s written procedures.  Further, these stickers must not fall off, or the drug product is misbranded.

Section 503 of the Act requires prescription drugs to bear the statement:  “Rx Only.”

Click here to see FDA Compliant Drug Product Labels from Applied.

Recommended Products

Applied Inside
What's New?
Categories
OxyGo (21)
General (11)
Oxygen (10)
Oxygencylinders (9)
OxySafe (8)
(8)
OSHA (7)
POC (7)
DOT (6)
Cylinders (6)
Deliveringoxygen (5)
Servomex (5)
FDA (5)
Medtrade (4)
GHS (4)
Medicaloxygen (4)
Fillingoxygen (4)
Cannula (3)
CGMP (3)
Leaktesting (3)
Carriers (2)
Financing (2)
Gastogas (2)
Concentrator (2)
Valves (2)
Competitivebidding (2)
Oxygen Safety (2)
Trainingaids (2)
Oxygo (2)
Brassandvitonwashers (2)
Liquidtogas (2)
Nosmokingsigns (2)
oxygen (2)
Oxygensafety (2)
Seminars (2)
Pigtails (2)
Mask (2)
Labels (2)
Training (2)
Portableoxygenconcentrator (2)
Tips And Tricks (2)
Transfilling (2)
Cylindervalveconnections (1)
Supplytubing (1)
Warehousesignage (1)
fillingoxygen (1)
transfilling (1)
LiquidtoGas (1)
FDAregistration (1)
LeakDetectionSolution (1)
Hazardousmaterial (1)
Servicearea (1)
Deliverybusinessmodel (1)
profit (1)
Oxygendeliveryarea (1)
Postvalveconnections (1)
Threadedvalveconnections (1)
CGA870 (1)
oxygendelivery (1)
Connections (1)
NPT (1)
Quickconnectors (1)
Improvingbusiness (1)
Hiringemployees (1)
medicaloxygen (1)
FDAguidance (1)
CGA540 (1)
HBS (1)
harvardbusinessschoolaward (1)
portableoxygenconcentrator (1)
oxygencylinders (1)
oxygenlabels (1)
planning (1)
budget (1)
Medicaloxygenregulator (1)
Conservers (1)
Medtradeseminar (1)
Privatebranding (1)
Investment (1)
Costreduction (1)
Comparisonchart (1)
Oximeter (1)
Non Deliverymodel (1)
Fingertip (1)
Pulserate (1)
Oxygensaturation (1)
refillingoxygencylinders (1)
Regulatoryrequirements (1)
liquidtogas (1)
gastogas (1)
driverdeliveryvehicles (1)
DMEcompanies (1)
oxygenprofits (1)
Oxygentraining (1)
Employeetraining (1)
FDAtraining (1)
Refillingyouroxygencylinders (1)
DOTtraining (1)
Oxygencleaning (1)
Cleaningequipment (1)
Disinfectingoxygenequipment (1)
Oxygenlabels (1)
Testingregulators (1)
Oxygencompressedlabels (1)
Labelupdate (1)
business (1)
DOTfines (1)
Shipping Papers (1)
Drivers (1)
DMEs (1)
Safety (1)
Oxysafe (1)
Tradeshows (1)
Trade Shows (1)
Spring (1)
Testimonals (1)
PatientStories (1)
IndustryNews (1)
Fire Stop Valves (1)
Travel (1)
POCs (1)
AppliedUniversity (1)
Industry News (1)
Trade Show (1)
OxyCareAdvantage (1)
Smart Delivery (1)
Bi Directional (1)
Firebreaks (1)
Fire Safety Valves (1)
Nuvo (1)
portableoxygen (1)
Snoring (1)
EPAP Mask (1)
EPAP (1)
OptiPillow (1)
OptiPillows (1)
OxyGoFit (1)
FIT (1)
poc (1)
Disposables (1)
bluetooth (1)
Technology (1)
Portable Oxygen (1)
Bluetooth (1)
FIT Connect (1)
OxyGo FIT (1)
Oxycare (1)
Tubing (1)
Nebulizers (1)
SOC (1)
Respiratorytherapists (1)
Teamwork (1)
Compliant Labels (1)
Cylinder Labels (1)
Misbranding Medical Oxygen (1)
Job (1)
Wantedad (1)
Salesrepresentative (1)
Westlakeinbloom2015 (1)
Westlake (1)
oxygenanalyzers (1)
Cylinder (1)
Corporatechallenge (1)
Boxes (1)
Bags (1)
Racks (1)
Carts (1)
Compressedgascylinders (1)
Warehousepersonnel (1)
Compressed USP (1)
handheldanalyzer (1)
OxyHome (1)
Smoking Cigarettes (1)
Portable Oxygen Concentrator (1)
Amazon Gift Card (1)
2016 (1)
Issue 3 (1)
Home HealthCare Today (1)
Oxygen Expenses (1)
Oxygen Costs (1)
Competitive Bidding (1)
Oxygen 101 (1)
rebateoffer (1)
Medtrade Spring 2016 (1)
Analyzer (1)
Oxystat (1)
Non Delivery Model (1)
Warranty (1)
continuingtraining (1)
DOTseminar (1)
MedtradeFall2015 (1)
Employees (1)
Fillingparts (1)
Disposablerespirator (1)
GHS and OSHA (1)
Oxygenconcentrators (1)
ISO8359 (1)
Fdacgmptraining (1)
Oxygentrainingbypersonnel (1)
FDAandDOTrequirementsforcylinderstorage (1)
minioxygenstorageaudit (1)
GHS symbols for oxygen labels (1)
OSHA requirements for oxygen cylinder labels (1)
Specifiedgases (1)
oxygen cylinder labels (1)
regulatoryrequirements (1)
oxygensystems (1)
conservers (1)
makingmoney (1)
competitivebidding (1)
transportingcylinderssafely (1)
ISOstandards (1)
Calibrationgases (1)
cylinderbags (1)
Liquidgases (1)
communityservicedaysatApplied (1)
Signageforoxygenmanufacturers (1)
Signageforoxygendistributors (1)
ResMedS9 (1)
Medicaltubing (1)
CPAPtubing (1)
CGAconnections (1)
Cryogenichoses (1)
Calibratingoxygenanalyzers (1)
Transfillingsiterequirements (1)
Vehiclerequirements (1)
Accreditationrequirements (1)
Oxygencertified (1)
Nitrogencertified (1)
Paramagneticoxygenanalyzers (1)
Oxigraf (1)
cylindercarriers (1)
cylinderracks (1)
Accessingonlineclasses (1)
SDS (1)
Oxygraf analyzer (1)
calibration gases (1)
oxygen analyzer (1)
VA (1)
Patient Safety (1)
Product Reviews (1)
Patient Bags (1)
NIST Standards (1)
FDA Compliant Drug Product Labels (1)
Thermometer (1)
High Pressure Gauges (1)
Calibration (1)
QCU (1)
Better Oxygen Business (1)
System (1)
Supplying Medical Oxygen (1)
SOP (1)
New labeling and Hazcom training requirements (1)
cylindercarts (1)
filling oxygen (1)
CPAP (1)
buyingoxygeninbulk (1)
fillingoxygencylinders (1)
medicaloxygenandcuttingcosts (1)
DME (1)
increasingprofitsformedicaloxygen (1)
transfillingmedicaloxygen (1)
filling cylinders (1)
FDA training (1)
DUNs number (1)
transferring oxygen (1)
FDA registration (1)
required training (1)
employee training (1)
Job specific training (1)
DOT training (1)
AppliedUniversityWalkthroughvideo (1)
Onlineclassinstructions (1)
Isolationkits (1)
Oxygenfilling (1)
FederalLawoncGMP (1)
DOTinPlainEnglish (1)
Trainingworkbooks (1)
CGA (1)
Regulators (1)
Cylindercarts (1)
Cylinderbags (1)
Cartsandracks (1)
OxyFillLiquidtoGasOxygenRefillingSystem (1)
Rattle Lessracks (1)
LiquidtoGastransfillsystem (1)
MedtradeFall2014 (1)
Cylinderracks (1)
DOTvehiclerequirements (1)
Oxygenvehicles (1)
CleanerDisinfectant (1)
OxyFillGastoGasRefillingSystem (1)
FDA Registration (1)
ConcentratorCleaner (1)
Oxygenfires (1)
Cleanerdisinfectant (1)
Singlelumenconserver (1)
OxyPulse (1)
Oxygenconserver (1)
USDOT (1)
Driverdailylogbook (1)
Thermalshutoffdevice (1)
Cannulafires (1)
Transfilling Oxygen (1)
Batchproductionrecords (1)
Lotstickers (1)
Fillingaccessories (1)
Cuttingoxygencosts (1)
Gastogassystem (1)
Liquidtogassystem (1)
Drug Listing (1)
OxygenEquipmentCleaner (1)
3GLabelRemover (1)
Leaktestingsolution (1)
Gaugecalibration (1)
Oxygenservice (1)
Oxygenequipmentcleaner (1)
Oxygencompatiblecleaners (1)
Oxygentransfillingsystem (1)
Pigtailinspectionform (1)
Calibrationchart (1)
Thermometercalibration (1)
Equipmentcalibration (1)
Non Flammablegasplacard (1)
ExpirationDate (1)
Lot (1)
LabelGun (1)
Monarch (1)
OxyMark (1)
2014OxygenSeminar (1)
AccreditationSeminar (1)
Oxygenplacard (1)
Oxygenvehicle (1)
Oxygensupplier (1)
Medicaloxygencylinders (1)
Analyzermaintenance (1)
OxygenUSP (1)
Paramagneticoxygenanalyzer (1)
Inhousetraining (1)
Employeetrainingformedicaloxygen (1)
OxyLok (1)
Valveseals (1)
Cylindershoulders (1)
CPAPTherapy (1)
Regulator (1)
Cylindervalve (1)
Plasticwashers (1)
Nylonwashers (1)
Carts And Racks (1)
Oxygen Delivery (1)
Pictograms (1)
FreeCPAPmaskfitting (1)
Sleep (1)
+ Show More
Free Subscription!

Get the latest regulatory info, accreditation news and exclusive discounts!

Applied University