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U.S. Department of Health and Human Services

Drugs

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Capsule 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?
 
11.    How does your product’s dimensions compare with the dimensions of the RLD capsule?
 
12.    What is your proposed capsule content (e.g., powder filled, pellet filled, or liquid filled) as compared to the RLD?
 
13.    What is your proposed capsule shell (soft or hard), size, sealing, and color of cap and body, as compared to the RLD?
 
14.    How are the conditions of 21 CFR 206 (Imprinting of Solid Oral Dosage Form) met?
 
15.    Does the RLD labeling have any labeling statements related to the release or design of the capsule? If so, how does your proposed statements compare to the RLD?
 
Container/Closure System
16.    How does your proposed container/closure system differ from the container/closure system of the RLD?
 
17.    What child-resistant feature(s) are utilized for each of your proposed packaging configurations?
 
Product Line
18.    How do your package configurations compare with the package configurations of the RLD? (e.g., use of unit dose cartons).
 
Storage Conditions
19.    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 
20.    How do your dispensing recommendation statements compare with the dispensing recommendation statements of the RLD?
 
SPL Data Elements 
21.    Are the SPL Data Elements consistent with the information provided in your application and in the insert labeling?
 
Medwatch 
22.    Are the FDA Toll Free Number, MedWatch web address and manufacturer’s phone number present in the labeling?
 
REMS
 
23.    Is a Risk Evaluation and Mitigation Strategy (REMS) required for the proposed product?
 
24.    Is a non-REMS risk mitigation strategy in place for the RLD, e.g., a Riskmap?
 
Petitions 
25.    Is your proposed product subject to any petitions?
 
Pregnancy Registry
26.    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:
 
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 the 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 the 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 your container labels and carton labeling? 
 
20.     Are you proposing a product with Tall Man Lettering?
  

Product-Specific LABELING QUESTIONS

 
  • Extended-release capsules
 
1.      What warnings and information are present in the labeling about breaking or opening the capsule?
 
2.      How does the kinetic data of your product compare with that of the RLD?
 
3.      How does your product’s release mechanism compare with the RLD’s release mechanism?
 
4.      Does the RLD labeling have any labeling statements related to the release or design of the capsule? If so, how does your proposed statements compare to the RLD?
 
  • Sprinkled capsules
 
1.      How does the labeling of the RLD and your proposed product identify this as a sprinkleable/dispersable capsule?
 
2.      Do the instructions for use differ from those of the RLD? If so, have similar instructions been approved for another of your approved drug applications?