Over The Counter Drugs
(OTC)
Dina R. Utter
MSN Student
Viterbo University
Prescription vs. Non Prescription
(OTC) Drugs

Determined by the U.S. Food and Drug
Administration (FDA).

FDA also decides when a prescription drug can
be used as an OTC drug.

Center for drug evaluation and Research
(CDER), a branch of FDA oversees OTC drugs
and prescription drugs.
OTC Drug History

1938: Federal Food Drug Cosmetic Act (FFDCA)
drug safety requirement.

1951: Durham-Humphrey Amendments to Federal
Food, Drug and Cosmetic Act (FFDCA)
designated drugs that cannot be used safely
without professional supervision as prescription
drugs and all other drugs as OTC.
OTC Drug History



1962: Drug Amendments to FFDCA added
efficacy requirement. Drug Efficacy Study
Implementation (DESI) retrospective review
of efficacy of 1938 - 1962
New Drug Application (NDA) began in 1966.
1972: FDA established OTC drug review
procedures for classification of all OTC drugs
on the market.
OTC Drug History


In order for an OTC drug active ingredient to be
included in an OTC monograph it must have been
marked prior to May 11, 1972.
Two legal pathways for OTC drug marketing post
1938.



Marketing in compliance with drug monograph
Marketing under the authority of an approved New drug
application (NDA).
Any medication proposed for OTC availability after
May 11, 1972 must undergo the new drug
application (NDA) process.
OTC Drug Review Process

Designed to produce OTC monographs
(regulatory standards) for marketing of
nonprescription drug products not covered by NDA

OTC monographs describe ingredients,
indications, and labeling requirements for OTC
products that are recognized as safe and effective
OTC Drug Review Process
Phase I

First Phase: Accomplished by advisory
review panels

These advisory panels


Review the ingredients to determine safety and
effectiveness for self treatment.
Appropriate labeling: including therapeutic indications,
dosage instructions and warnings about side effects and
preventing misuse
OTC drug review
Phase I cont.

Advisory panel: Classifies drug ingredients
into three categories:



Category I: safe and effective for the claimed therapeutic
indication
Category II: not as safe and effective or unacceptable
indications
Category III: Insufficient data available to permit final
classification.
OTC Drug Review
Phase II

The agency reviews ingredients in each class
of drugs based on.



The panel’s findings, public comment, and any
new data that may have become available.
The agency publishes conclusions in the
Federal Register in the form of a proposed
monograph.
Time is allotted for objections to the proposal
or for request for a hearing before the
commissioner of the FDA.
OTC Drug Review
Phase III

The publication of the final drug monograph.

The monographs establish conditions under
which certain OTC drugs are recognized as
safe and effective.
OTC Drug Monograph

Final OTC monograph establishes the
acceptable:
• active ingredients
• concentration of the active ingredients
• therapeutic claims
• indications
• labeling/warning requirements
• directions for use
Sample OTC Labeling (Monograph)






Drug Facts
Active ingredient
Purpose
XXXXXXXXXXXXXX.............................................................................Antifungal
Uses  cures most athlete’s foot (tinea pedis)  relieves itching, burning, cracking, and
scaling.
WarningsFor external use only Do not use on children under 2 years of age unless
directed by a doctorWhen using this product do not get into eyes. If contact occurs, rinse
eyes thoroughly with water.Stop use and ask a doctor if irritation occurs or if there is no
improvement within 4 weeks.Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right away.
Directions wash the affected area and dry thoroughly.  apply a thin layer of the
product over affected area twice daily (morning and night) or as directed by a doctor
supervise children in the use of this product.  for athlete’s foot:  pay special attention
to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and
socks at least once daily. use daily for 4 weeks. If condition persist longer, ask a
doctor. This product is not effective on scalp or nails
Other information XXXXXXXInactive ingredients XXXXXXXQuestions or comments?
Call 1-800-XXX-XXXX.
Prescription to OTC switch
Examples of OTC switch:
OTC Switch


Occurs when NDA holder of approved
prescription drug files NDA or supplement for
approval of OTC product.
The NDA holder may gain 3 years of
marketing
exclusivity for OTC “conditions of use” if
switch is
based on:



New clinical investigation(s)
Conducted or sponsored by the applicant
Essential to approval
OTC Switch Candidates


Acceptable margin of safety based on prior
prescription
marketing experience.
OTC dosages/indications are relatively safe





low misuse potential
minimal abuse potential
reasonable therapeutic window of safety
Self treatment and monitoring with minimal
physician
supervision.
Adequately labeled to allow safe and effective
use of the
OTC drug and benefits from the switch clearly
outweigh the risks.
OTC Switch
Final Thoughts

Imagine what it would be like if OTC
medications were not so rigoursly monitored.

Wouldn’t you love to call your primary care
provider (PCP) every time you had a cold,
headache or a fever.
References
Federal Food and Drug Administration.
http://www.fda.gov. Retrieved February 22,
2005.
Rules and regulations. Federal Register, 67
(15). Retrieved February 22, 2005,
http://www.fda.gov.