Attachment VIII - CLAT Labeling Review Examples.xlsx

Labeling Review Activities

Is the established (proper) name at least ½ the size of the proprietary name? (Rx only)

• Proprietary name

• Established name

• Product strength

• Identifying lot or control number

• Name of manufacturer, packer, or distributor of the drug Note: the label should also include the expiration date and NDC number whenever possible.

For Specified Biologic [21 CFR 201.10(g)(2)] Mydrug (drugozide) Injection

For Non-Specified Biologic [21 CFR 610.62(a)] drugozide Mydrug Injection

For example:

• Must be diluted. For intravenous infusion.

• Must be reconstituted and further diluted. For intravenous infusion.

• Discard within XX hours after opening or after assembly

• After first use, refrigerate or keep at a temperature not greater than XX for XX days.

• [DRUG NAME] may be kept at room temperature (up to 25°C (77°F)) in the original carton and must be used within XX days. Use space below to record the date removed from the refrigerator.

All products BOTH Container Label and Carton Labeling Principal display panel (PDP) Dosage Form For NDA: Is the finished dosage form present and located either in the same line as the active ingredient (established name) or directly below the active ingredient (established name)?

For BLA: Is the finished dosage form present and located below the proper name?

New Molecular Entity (NME) BOTH Container Label and Carton Labeling Principal display panel (PDP) Strength For New Molecular Entity (NME): Does the strength match the established name?

• Dose/kg/day for a set amount of days (e.g., 30 mg/kg daily for 5 days)

• Dose/kg/dose every XX hours (e.g., 10 mg/kg every 8 hours) Product with diluent BOTH Container Label and Carton Labeling Principal display panel (PDP) Dilution For products co-packaged with a diluent:

FOR CONTAINER LABEL: Is the presentation on the container for the DILUENT similar to the example below where the word “diluent” is most prominently displayed on the PDP?

Diluent For DRUGNAME for Injection

Notes:

• Ensure the net quantity statement for the Diluent appears away from the drug name and have less prominence on the PDP.

• Add the statement “For drug diluent use only – reconstitute as directed” to the bottom of the PDP (space permitting) or on the side panel.

FOR CARTON LABELING: Does the carton labeling include the amount (net quantity) of diluent included in the kit (see example below)?

This carton contains:

- 1 vial of DRUGNAME (established name) dosage form, strength

- 1 vial of Diluent for DRUGNAME, XX mL

• Avoid recommending the use of insulin syringes to deliver doses for non-insulin drug products.

• Insulin syringes are marked in units, and medication errors have occurred when patients or healthcare providers have converted units to mL or mg or vice versa.

All products BOTH Container Label and Carton Labeling Principal display panel (PDP) NDC Number For products packaged in a container and a carton: Ensure that the NDC number assigned to the container label and the NDC number assigned to the carton labeling is appropriate. • If a carton contains multiple containers, then the carton labeling should have a different NDC package code (last 2 digits of the NDC) than the containers within the carton. However, they could have the same NDC number if the quantity within the carton is equal to the quantity in the container. For example:

o 1 carton containing 1 vial/unit can have same NDC number o 1 carton containing more than 1 vial/unit should have different NDC package codes All products Prescribing Information (PI) Section 16: How supplied/storage and handling NDC Number For products packaged in a container and a carton: Ensure that the NDC number assigned to the inner label (container) and the NDC number assigned to the outer labeling (carton) is appropriate. • 1 carton containing 1 vial can have same NDC number

• 1 carton containing more than 1 vial/unit should have different NDC number

ONCE DAILY

Drug Name XL (established name) capsules XX mg

Ensure information on post-opening expiration date and space for patients to write the post-opening expiration date is available on the label.

• E.g. “Date of first opening __/__/__. Discard unused portion XX days/weeks/months after first opening.”

For example:

• 30-tablets bottle: NDC 11111-222-30

• 90-tablets bottle: NDC 11111-222-90

• Use “only” if there is a safety concern and not for routine placement on newly approved products (e.g. For Ophthalmic Use Only)

• Ensure that the concentration per milliliter (mL) is expressed as XX mg/mL (not XX mg/1 mL). **The following situations are exceptions to this USP requirement for expression of strength for these drug products:

• Insulin drug products: the only expression of strength is strength/mL because only a portion of the supplied total volume is typically administered at a time. (i.e. 100 units/mL (U-100)

• Drug products that are ordered and administered by percentage strength [e.g., drug products for local anesthesia (e.g., lidocaine injection)]: e.g., 1% or 2%. Three expressions of strength are required for products in which the total volume is greater than 1 mL (percentage strength, strength per total volume, and strength/mL). For example: 1% (100 mg/10 mL) (10 mg/mL)

• Autoinjectors in which the entire content is administered and there is no possibility of administering a partial dose: Only include the strength per total volume (not the strength/mL). (i.e.150 mg/1.14 mL)

• Dry solids (e.g.; lyophilized powders) that must be reconstituted prior to administration: Only list the total strength of the drug (not the strength per total volume nor strength/mL).

• Ensure the total quantity per total volume is prominently displayed.

• Ensure the dosing instructions clearly indicate whether the weight-based dosing is based on actual vs. ideal body weight.

Risk of Death due to Medication Errors Inadvertent administration of DRUG NAME to a patient for whom it is not intended can result in paralysis, respiratory arrest, and death. Ensure proper selection of intended product and avoid confusion with other injectable solutions that may be present in critical care settings. Ensure that the dose is communicated clearly, and that the intended product is properly selected.

At the bottom of the DOSAGE AND ADMINISTRATION section, does the PI contain the subsection, Risk of Medication Errors: Store DRUG NAME with the cap and ferrule intact. Accidental administration of neuromuscular blocking agents may be fatal. Store these products in a way that minimizes the possibility of selecting the wrong product

• For parental dosage forms (e.g., injection, for injection) include information about color (e.g., clear solution) and other identifying characteristics

• For currently marketed products, is the established name on the FDA tall man list? If yes, recommend tall man lettering for the established name on all labels and labeling for both brand and generic products.

• For new generics that use tall man lettering, use a lower case letter for the first letter in the established name unless it is part of the tall man lettering.

• Strength

• Package configuration

• Description of container

• Information to facilitate identification of the dosage forms

• NDC number

• Special handling and storage conditions

• Single-dose vial

• Multiple-dose vial

• Single-patient-use container (e.g. pen, cartridge)

• Unit-dose blister pack

• Wallet card contain XX tablets

• Pharmacy Bulk Package – Not for Direct Infusion (should be on PDP)

Is the strength expressed with the use of a leading zero? (i.e., 0.5 mg rather than .5 mg) All products Prescribing Information (PI) Section 3: Dosage Forms and Strengths Strength Is the strength expressed without the use of a terminal zero? (i.e., 1 mg rather than 1.0 mg) Is the strength expressed with the use of a leading zero? (i.e., 0.5 mg rather than .5 mg) All products BOTH Container Label and Carton Labeling Principal display panel (PDP) Strength Is the strength expressed without the use of confusing abbreviations, acronyms, and symbols?

(see ISMP’s List of Error Prone Abbreviations)

• If dose is constant but space does not permit: “See prescribing information”

• If dose is variable: “See prescribing information”

If yes, ensure that the graphic design does not compete in prominence with the proprietary name.

Resources Resources

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM349009.pdfhttp://www.ismp.org/tools/errorproneabbreviations.pdfhttp://www.ismp.org/tools/highalertmedications.pdfhttp://www.ismp.org/tools/highalertmedications.pdfhttp://www.ismp.org/tools/drugnamesuffixes.pdfhttp://www.ismp.org/tools/DoNotCrush.pdfhttp://www.ismp.org/tools/tallmanletters.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM331810.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM379753.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075066.pdfhttp://www.fda.gov/downloads/Drugs/Guidances/UCM188992.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075082.pdfhttp://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm389069.pdfhttps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM621044.pdfhttps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM569607.pdf Legend