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U.S. Department of Health and Human Services

Drugs

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LRB QbR for Oral Solutions and Suspensions

INTRODUCTION:                          

ANDA Number
Date of Submission
Applicant’s Name
Established Name of the Drug Product
Proprietary Name of the Drug Product (include date proposed)
Labeling Submissions
 
QbR Questions:
 
Model Labeling 
1.       What model labeling is your product labeling based upon?
 
USP Monograph 
2.       Is there a USP Drug Product Monograph and if so, does your product’s labeling meet the USP requirements?
 
Patents and Exclusivities 
3.       What are the currently approved patents and exclusivities for the reference listed drug as listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) and what impact do they have on the labeling submitted? 
                             
4.       What are the certifications and labeling impacts for each patent and exclusivity?
 
Inactive Ingredients 
5.       Is the listing of inactive ingredients in the DESCRIPTION section of the package insert consistent with the listing of inactive ingredients found in the statement of components and composition and SPL data elements?
 
6.       Are the proposed inactive ingredients consistent with the inactive ingredients of the Reference Listed Drug (RLD)?
 
7.       Do any of your inactive ingredients require special labeling statements or have regulatory requirements?
 
Manufacturing Facility 
8.       Who manufactures the drug product?
 
9.       Who distributes the drug product?
 
Product Description 
10.     How does your product description in the insert labeling compare with the product description in the Finished Product Specifications?
 
11.     Must the product be diluted prior to administration?  If so, how is this made clear to the health care provider? Is the volume needed for reconstitution to reach the target concentration different than the RLD?  If so, please justify. 
 
12.     What warnings or instructions are present in the labeling about the product and how does it compare with the reference product? (e.g., patient instructions for use).
 
13.     How do flavorings compare with those present in the RLD product?
 
Container/ Closure System 
14.     How does your container/closure system compare with the container/closure system of the RLD?
 
15.     Are there measuring markings, or measuring tools (cups/syringes) that the RLD provides with their product, and if so how does your product compare?
 
16.     Please discuss any child-resistant feature(s) are utilized for each of your proposed packaging configurations?
 
17.     Are proposed bottles sizes the same sizes marketed by the RLD? 
 
Product Line 
18.     How do your packaging configurations compare with the packaging configurations of the RLD? (e.g., use of individual cartons)
 
Storage Conditions 
19.     How does your storage temperature statement, including storage after reconstitution, compare with the storage temperature statement of the RLD?
 
20.     Is this product light sensitive?  If so, do the labeling recommendations and/or special packaging address light sensitivity? 
 
Dispensing Recommendations
 
21.     How do your dispensing recommendation statements compare with the dispensing recommendation statements of the RLD?
 
SPL Data elements 
22.     Are the SPL Data Elements consistent with information provided in your application and in the insert labeling?
 
Medwatch 
23.     Are the FDA Toll Free Number, MedWatch web address and manufacturer’s phone number present in the labeling?
 
REMS 
24.     Is a Risk Evaluation and Mitigation Strategy (REMS) required for the proposed product?
 
25.     Is a non-REMS risk mitigation strategy in place for the RLD, e.g., a Riskmap?
 
Petitions 
26.     Is your proposed product subject to any petitions? 
 
Pregnancy Registry 
27.     Does RLD labeling reference a pregnancy registry and if so, do you also propose a pregnancy registry. Please provide your rationale for not including a registry that appears in the labeling of the RLD. 
 
 
Additional Questions:
 
Over-The-Counter 
1.       Is your product an Over-the-Counter medication?
 
2.       If so, explain how it meets content and format regulations set forth in the regulations?
 
3.       Have you included a legend with your submission?
 
4.       How does your product meet tamper-resistant requirements set forth in 21 CFR 211.132?
 
Controlled Substance Labeling
1.       Controlled Substance Labeling
 
2.       Is your product a controlled substance?
 
3.       If yes, does labeling meet regulatory requirements for location and size of symbol?
 
4.       Does the proposed packaging meet requirements for tamper-evident sealing?
 
NDC Codes 
1.       Is your drug product registered?
 
2.       Does your product meet the conditions of 21 CFR 207.35(b)(3)(i), regarding the proper  placement of the NDC code on labeling?
 
Lot Numbers
Does a lot number, control number, or batch number appear on the label as described in 21 CFR 201.18?
  
Bar Coding 
How are the conditions of 21 CFR 201.25 met?    
                                           
Formatting, wording preferences 
1.       Do your labels and labeling meet formatting requirements set forth in the regulations, e.g., font size?
 
2.       Is the route of administration prominently displayed on the principal display panel?
 
Instruction for Use 
1.        How do the instructions for use differ from those of the RLD?
 
2.       If the instructions differ from the RLD, have similar instructions been approved for another of your approved drug products? 
 
Medication Guide 
1.       How does the Medication Guide for this product differ from that approved for the RLD?
 
2.       How will the Medication Guide be provided with the product and how many will accompany each package size?
 
3.       Are the conditions of 21 CFR 208.20 met with regard to proper Medication Guide formatting?
 
4.       Do the proposed container labels direct the health care provider to dispense the Medication Guide as required by 21 CFR 208.24(d)?
 
5.       Have requirements for providing a toll-free number for reporting adverse events been met by including the following text with the Medication Guide?
 
Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA 1088.
 
Patient Information Leaflet 
1.       How does the Patient Information Leaflet for this product differ from that approved for the RLD?
 
2.       How will the Patient Information Leaflet be provided with the product and how many will accompany each package size?
 
3.       Have requirements for providing a toll-free number for reporting adverse events been met by including the following text with the patient information?
 
Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA 1088.
 
Differentiation
1.       Are your product strengths sufficiently differentiated to reduce chance of medication errors?
 
2.       Where there is a possibility the products will be stored in close proximity, is there adequate differentiation between your proposed product and your approved products?  (For example, 250mg/5mL vs 500mg/5mL formulations)   
 
3.       Is there sufficient contrast between the expression of strength and background color on container labels and carton labeling? 
  
4.      Are you proposing a product with Tall Man Lettering?