[Federal Register Volume 70, Number 169 (Thursday, September 1, 2005)]
[Proposed Rules]
[Pages 52050-52051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17390]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 310

[Docket No. 2005N-0345]
RIN 0910-AF72


Drug Approvals: Circumstances Under Which an Active Ingredient 
May Be Simultaneously Marketed in Both a Prescription Drug Product and 
an Over-the-Counter Drug Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this advance 
notice of proposed rulemaking to request comment on whether to initiate 
a rulemaking to codify its interpretation of section 503(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301, et seq.), 
regarding when an active ingredient may be simultaneously marketed in 
both a prescription drug product and an over-the-counter (OTC) drug 
product.

DATES: Submit written or electronic comments by November 1, 2005.

ADDRESSES: You may submit comments, identified by Docket No. 2005N-0345 
and/or RIN number 0910-AF72, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.

Written Submissions

    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No. or Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm, including any personal 
information provided. For detailed instructions on submitting comments 
and additional information on the rulemaking process, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: For further information contact the 
FDA at 301-827-0002 or by e-mail at [email protected]. This phone 
number and this e-mail account have been set-up to address questions 
relating to this notice.

SUPPLEMENTARY INFORMATION:

I. Background

    Since Congress first enacted the Federal Food, Drug, and Cosmetic 
act (the act) in 1938, there has been a great deal of discussion about 
when drug products should be sold as prescription drugs as opposed to 
OTC drugs.

[[Page 52051]]

    Until 1951, the act did not contain criteria for determining when 
to limit a drug's approval to prescription use. Consequently, different 
manufacturers made different decisions about whether to market a drug 
as prescription or OTC. This resulted in confusion and uncertainty for 
pharmacists and consumers, and made it difficult for FDA to ensure that 
the only drugs available OTC were those that were safe for use without 
the supervision of a licensed medical practitioner.
    To eliminate this confusion and uncertainty, and to protect the 
public health, Congress enacted the Durham-Humphrey Amendments in 1951 
(Public Law 82-215, 65 Stat. 648). Congress had two primary objectives 
in enacting the Amendments: (1) To protect the public from abuses in 
the sale of potent Rx drugs; and (2) to relieve retail pharmacists and 
the public from burdensome and unnecessary restrictions on the 
dispensing of drugs that are safe for use without the supervision of a 
physician. See S. Rep. No. 946, at 1 (1951), reprinted in 1951 
U.S.C.C.A.N. 2454. To this end, the new legislation codified a 
statutory definition of prescription drug in section 503(b) of the act.
    Section 503(b) of the act sets forth the Federal standard used to 
classify drugs as prescription or OTC, and it describes when and how to 
switch a drug from prescription to OTC status. Section 503(b)(1) of the 
act defines a prescription drug as:

    (1) A drug intended for use by man which--
    (A) because of its toxicity or other potentiality for harmful 
effect, or the method of its use, or the collateral measures 
necessary to its use, is not safe for use except under the 
supervision of a practitioner licensed by law to administer such 
drug; or
    (B) is limited by an approved application under section 505 to 
use under the professional supervision of a practitioner licensed by 
law to administer such drug.

    The act does not define ``OTC drug,'' but the term has been adopted 
to refer to any drug that does not meet the definition of prescription 
drug in section 503(b) of the act.
    Given this dichotomy between prescription and OTC drugs, questions 
have arisen over the years about whether there are any conditions under 
which an active ingredient may be simultaneously marketed in both a 
prescription drug product and an OTC drug product. FDA has interpreted 
the language in 503(b)(1) of the act to allow marketing of the same 
active ingredient in products that are both prescription and OTC, 
assuming some meaningful difference exists between the two that makes 
the prescription product safe only under the supervision of a licensed 
practitioner. Examples of such drugs include: Meclizine (prescription 
for vertigo/OTC for nausea with motion sickness); Clotrimazol 
(prescription for candidiasis/OTC for athlete's foot, ring worm, jock 
itch); Loperamide (prescription for chronic diarrhea/OTC for acute 
diarrhea); Nicotine products (prescription for administration through 
inhalers and nasal sprays/OTC in gums, lozenges and patches); 
ibuprofren (prescription at 400mg+ for arthritis/OTC at 400mg and below 
for aches and pains); and H2 blockers (prescription at 300mg+ for 
ulcers/OTC at 200mg for heartburn). The key distinction in these 
examples is that there is some meaningful difference between the two 
products (e.g., indication, strength, route of administration, dosage 
form) that makes the prescription product safe only under the 
supervision of a licensed practitioner. To date, FDA has not allowed 
marketing of the same active ingredient in a prescription product for 
one population and in an OTC product for a subpopulation.

II. Agency Request for Information

    Despite the preceding examples, we recognize that FDA's 
interpretation of section 503(b) of the act has not been explicitly set 
forth in any of the regulations that discuss the process by which FDA 
classifies (or re-classifies) drugs as OTC or prescription. See, e.g., 
21 CFR 310.200 and 310.201.
    To address this concern, we therefore ask for comments on the 
following questions:
1.
    A. Should FDA initiate a rulemaking to codify its interpretation of 
section 503(b) of the act regarding when an active ingredient can be 
simultaneously marketed in both a prescription drug product and an OTC 
drug product?
    B. Is there significant confusion regarding FDA's interpretation of 
section 503(b) of the act?
    C. If so, would a rulemaking on this issue help dispel that 
confusion?
2.
    A. If FDA limited sale of an OTC product to a particular 
subpopulation, e.g., by making the product available to the 
subpopulation by prescription only, would FDA be able to enforce such a 
limitation as a matter of law?
    B. If it could, would it be able to do so as practical matter and, 
if so, how?
3.
    A. Assuming it is legal to market the same active ingredient in 
both a prescription and OTC product, may the different products be 
legally sold in the same package?
    B. If the two products may be lawfully sold in a single package, 
under what circumstances would it be inappropriate to do so?

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m. Monday through 
Friday.

    Dated: August 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17390 Filed 8-26-05; 4:59 pm]
BILLING CODE 4160-01-S