Innovative Approaches for Nonprescription Drug Products

Administrative draft guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

17765437dft
07-13-18
Innovative Approaches
for Nonprescription Drug
Products
Guidance for Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 60 days of
publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit electronic comments to https://www.regulations.gov. Submit written
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the
docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document, contact (CDER) Chris Wheeler at 301-796-0151.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
July 2018
OTC

Innovative Approaches
for Nonprescription Drug
Products
Guidance for Industry
Additional copies are available from:
Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: druginfo@fda.hhs.gov
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
July 2018
OTC

Contains Nonbinding Recommendations
Draft — Not for Implementation
TABLE OF CONTENTS
I. INTRODUCTION............................................................................................................. 1
II. BACKGROUND ............................................................................................................... 2
III. INNOVATIVE APPROACHES FOR NONPRESCRIPTION DRUG PRODUCTS . 3
A. Labeling in Addition to the DFL for Nonprescription Drug Products ..................................... 3
B. Nonprescription Drug Products With Additional Conditions for Safe and Effective Use ...... 3

Contains Nonbinding Recommendations
Draft — Not for Implementation
1
Innovative Approaches for Nonprescription Drug Products	1
Guidance for Industry1
2
3
4
This draft guidance, when finalized, will represent the current thinking of the Food and Drug	5
Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not	6
binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the	7
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible	8
for this guidance as listed on the title page.	9
10
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I. INTRODUCTION	14
15
This guidance describes two innovative approaches that may be useful to consider for	16
demonstrating safety and effectiveness for a nonprescription drug product in cases where the	17
drug facts labeling (DFL) alone is not sufficient to ensure that the drug product can be used	18
safely and effectively in a nonprescription setting: (1) the development of labeling in addition to	19
the DFL, and (2) the implementation of additional conditions so that consumers appropriately	20
self-select and use the product.	21
22
The appropriateness and specific details of either of these approaches will depend on the	23
circumstances that apply to a particular drug product.	24
25
These innovative approaches may be useful for applicants intending to develop and seek	26
approval of certain nonprescription drug products through the submission of a new drug	27
application (NDA), including an application submitted pursuant to section 505(b)(2) of the	28
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355).2	
29
30
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.	31
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only	32
as recommendations, unless specific regulatory or statutory requirements are cited. The use of	33
the word should in Agency guidances means that something is suggested or recommended, but	34
not required.	35
36
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1 This guidance has been prepared by the Office of Medical Policy in the Center for Drug Evaluation and Research
at the Food and Drug Administration at the Food and Drug Administration.
2 The recommendations on the innovative approaches presented in this guidance may also be appropriate for
combination products (as defined at 21 CFR 3.2(e)) subject to review under a new drug application (NDA).

Contains Nonbinding Recommendations
Draft — Not for Implementation
2
II. BACKGROUND	38
39
FDA approves new drugs3 as prescription or nonprescription drug products under section 505 of	40
the FD&C Act (21 U.S.C. 355). A drug product must be dispensed by prescription if it is not	41
safe to use except under the supervision of a practitioner licensed by law to administer the drug	42
(health care practitioner) (see section 503(b)(1) of the FD&C Act (21 U.S.C. 353(b)(1)). If a	43
drug product does not meet the criteria for prescription-only dispensing, it may be marketed as a	44
nonprescription drug product.	45
46
FDA determines whether the information submitted as part of a new drug application (NDA) for	47
a nonprescription drug product is sufficient to ensure that the drug product is safe and effective	48
for nonprescription use under the conditions prescribed, recommended, or suggested in its	49
proposed labeling (see sections 505(d) and 503(b)(1) of the FD&C Act (21 U.S.C. 355(d) and	50
353(b)(1)). Studies regarding self-selection and actual use can help demonstrate that the drug	51
product is safe and effective for use without the supervision of a health care practitioner. Self-	52
selection studies test whether consumers can apply information in the drug product’s labeling to	53
their personal medical situations and make correct decisions to use or not use the drug product,	54
and actual use studies provide information on how consumers will use the drug product.4	
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Nonprescription drug products must comply with applicable labeling requirements for over-the-	57
counter (OTC) drug products under 21 CFR part 201, including, but not limited to, the format	58
and content requirements for OTC drug product labeling under § 201.66. Labeling created to	59
satisfy the requirements in § 201.66 is commonly referred to as the DFL. The DFL is intended to	60
enable consumers to appropriately self-select and use the nonprescription drug product safely	61
and effectively. In instances where the DFL alone would not be sufficient, an applicant may	62
consider proposing innovative approaches, in addition to the DFL, to ensure that the drug	63
product is safe and effective for use as a nonprescription drug product.	64
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FDA believes the innovative approaches described in this guidance could lead to the approval of	66
a wider range of nonprescription drug products, including drug products that may treat chronic	67
conditions or other conditions for which the limitations of the DFL present challenges for	68
adequate communication of information needed for safe and effective use without the	69
supervision of a health care practitioner. Approval of a wider range of nonprescription drug	70
products has the potential to improve public health by increasing the types of drug products	71
consumers can access and use that would otherwise only be available by prescription.	72
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3 The term new drug is defined at section 201(p) of the FD&C Act (21 U.S.C. 321(p)).
4 See the guidance for industry Self-Selection Studies for Nonprescription Drug Products. We update guidances
periodically. For the most recent version of a guidance, check the FDA guidance web page at
https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.

Contains Nonbinding Recommendations
Draft — Not for Implementation
3
III. INNOVATIVE APPROACHES FOR NONPRESCRIPTION DRUG PRODUCTS	75
76
A. Labeling in Addition to the DFL for Nonprescription Drug Products	77
78
In addition to labeling created to satisfy the DFL requirements,5 FDA may approve additional	79
labeling for nonprescription drug products (see section 505(d) of the FD&C Act (21 U.S.C.	80
355(d)). Examples of nonprescription drug product labeling the Agency may consider approving	81
in addition to the DFL include, but are not limited to, the following:	82
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 Information leaflets or other documents contained inside the carton or container for the	84
nonprescription drug product	85
86
 Text or images on a video display, including interactive displays for consumers to review	87
88
 Information displayed on websites	89
90
 Statements or questions in a mobile application	91
92
B. Nonprescription Drug Products With Additional Conditions for Safe and	93
Effective Use	94
95
Applicants may consider proposing one or more additional conditions that consumers must fulfill	96
to ensure that the drug product is safe and effective for nonprescription use, when labeling alone	97
is not sufficient for this purpose.	98
99
Examples of additional conditions for safe and effective use that the Agency may consider,	100
particularly with regard to appropriate self-selection and actual use, include, but are not limited	101
to, the following:	102
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 Prior to purchase, the consumer is required to respond to a set of questions on a self-	104
selection test in a mobile application, and the outcome of the self-selection test	105
affirmatively indicates that the consumer is an appropriate candidate to use the	106
nonprescription drug product.	107
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 Prior to purchase, the consumer is required to view and affirm that they viewed text or	109
images in a video that describes how to appropriately use the nonprescription drug	110
product.	111
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As part of the development process for a nonprescription drug product for which an additional	113
condition for nonprescription use will be proposed, applicants should consider how to ensure	114
proper implementation of any additional condition necessary for safe and effective use.	115
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5 21 CFR 201.66

Contains Nonbinding Recommendations
Draft — Not for Implementation
4
We encourage applicants to meet with FDA staff to discuss any questions that arise during the	117
development of a nonprescription drug product for which an additional condition for safe and	118
effective use will be proposed.	119
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