• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Topical Dosage Form Questions

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 (proposed labeling pieces, e.g., container, carton, FPL, SPL, etc.)
 
QbR Questions:
 
Model Labeling 
1.      What model labeling(s) 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 Evaluation (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.      Do any of your inactive ingredients require special labeling statements or have regulatory requirements?
 
Manufacturing Facility 
7.      Who manufactures the drug product?
 
8.      Who distributes the drug product?
 
Product Description 
9.      How does your product description in the insert labeling compare with the product description in the Finished Product Specifications?
 
10.     How does your product description compare with the product description of the RLD?
 
Container/Closure System
11.     How does your proposed container/closure system differ from the container/closure system of the RLD?
 
12.     What child-resistant feature(s) are utilized for each of your proposed packaging configurations?
 
Product Line 
13.     How do your packaging configurations compare with the packaging configurations of the RLD? (e.g., use of unit dose cartons).
 
Storage Conditions 
14.     How does your storage temperature statement compare with the storage temperature statement of the RLD and USP (if applicable)? Please justify the differences.
 
Dispensing Recommendations 
15.      How do your dispensing recommendation statements compare with the dispensing recommendation statements of the RLD?
 
SPL Data Elements 
16.      Are the SPL Data Elements consistent with information provided in your application and in the insert labeling?
 
Medwatch 
17.      Are the FDA Toll Free Number, MedWatch web address and manufacturer’s phone number present in the labeling?
 
REMS
18.      Is a Risk Evaluation and Mitigation Strategy (REMS) required for the proposed product?
 
19.      Is a non-REMS risk mitigation strategy in place for the RLD, e.g., a Riskmap?
 
Petitions 
20.      Is your proposed product subject to any petitions?
 
 
Additional Questions:
 
Controlled Substance Labeling
 
1.       Is your product a controlled substance? If yes, does labeling meet regulatory requirements for location and size of symbol?
 
2.       Does the proposed packaging meet requirements for tamper-evident sealing?
 
NDC Codes 
3.       Is your drug product registered?
 
4.       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 
5.       Does a lot number, control number, or batch number appear on the label as described in 21 CFR 201.18?
  
Bar Coding 
6.       How are the conditions of 21 CFR 201.25 (Bar Code Label Requirements) met?
 
Over-The-Counter Products 
7.       How are the conditions of 21 CFR 211.132 (Tamper-evident Packaging Requirements for OTC) met?
 
Formatting, wording preferences
8.       Do your labels and labeling meet formatting requirements set forth in the regulations? (e.g., font size).
 
Medication Guides
9.       How does the Medication Guide for this product differ from that approved for the RLD?
 
10.     How will the Medication Guide be provided with the product and how many will accompany each package size?
 
11.     Are the conditions of 21 CFR 208.20 (Content and Format of a Medication Guide) met with regard to proper Medication Guide formatting?
 
12.     Do the proposed container labels direct the health care provider to dispense the Medication Guide as required by 21 CFR 208.24(d) (Distributing and Dispensing a Medication Guide)?
 
13.     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
14.      How does the Patient Information Leaflet for this product differ from that approved for the RLD?
 
15.      How will the Patient Information Leaflet be provided with the product and how many will accompany each package size?
 
16.      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
17.      Are your product strengths sufficiently differentiated to reduce chance of medication errors?
 
18.      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? 
 
19.      Is there sufficient contrast between the expression of strength and background color on container labels and carton labeling? 
 
20.      Are you proposing a product with Tall Man Lettering?
 

Product-Specific LABELING QUESTIONS

 
21.      Does your product deliver the same amount (delivery rate) when dispense as the reference listed drug?  For examples:  Foams/Sprays/Lotions?
 
22.      Is this an ear drop?  If yes:
            a.   Is the drop size the same as the reference listed drug?  
            b.   Is the ear drop labels clearly marked as ear drop in order to not confused this with eye drops?    
            c.   Is the pH range the same as the reference listed drug?
 
22.       Are you proposing a size that has not been approved for the reference listed drug?  If yes, Please comment/explain.