DRUG REGULATION AND

CONTROL

DIVINE GRACE M. PARCON, RPH

Federal Food and Drug Cosmetic Act of 1938

“prohibits the distribution and use of any new drug

of drug product without prior filing of a new drug
application(NDA) and approval of the FDA”

Sulfanilamide
Diethylene glycol poisoning
Durham-Humprey Amendment of 1952
“Prescription for legend drugs may not be refilled
without the express consent of the prescriber”

Drugs categorized according to manner in which

they maybe legally obtained
OTC use by lay-man in self-treatment of simple
conditions in which competent medical care is not
sought
 Prescription drugs – drugs that are considered
useful only after expert diagnosis or too dangerous
for use in self medication ( Rx or legend)
 Kefauver Harris Amendments

The sponsor of new drug should file an

investigational new drug application with the FDA
before the drug maybe clinically tested on human
subjects

Thalidomide – sedative and tranquilizer

phocomelia
Comprehensive Drug Abuse Prevention and Control Act of 1970

Consolidate and codify control authority over drugs

of abuse into a single statute
DEA Drug Enforcement Administration
5 Schedule for classification and control for drug
substance
1. Schedule I – no accepted medical use and with high potential
for abuse ( heroin, LSD,marijuana)
2. Schedule II – Drugs with acceptable medical uses and high
potential for abuse that may lead to severe psychologic or
physical dependence ( morphine, Cocaine methamphetamine,
amobarbital)
3. Schedule III – with acceptable medical use low potential for
abuse ( Codeine, hydrocodone)
4. Schedule IV – acceptable medical use and low potential for
abuse relative to those in schedule III (diphenoxin, diazepam,
oxazepam)
5. Schedule 5 – with acceptable medical uses and law potential
for abuse relative to those in schedule IV (dihydrocodeine and
diphenoxylate)
 Drug Listing Act of 1972

Provide FDA legislative authority to compile a list of

marketed drugs to assist in the enforcement of
federal laws requiring that drugs be safe and
effective and not adulterated or misbranded
Drug Price Competition and Patent Term Restoration Act of 1984

Applications for generic copies of an originally

approved new drug can be filed through an
abbreviated new drug application (ANDA)
 Prescription Drug Marketing Act of 1987

The act is intended to reduce the risk of adulterated,

misbranded, repackaged and mislabeled drugs
entering the legitimate marketplace through
“secondary sources”
Summary
1. Reimportation
2. Sales Restrictions
3. Distribution of Samples
4. Wholesale distributors
Dietary Supplement Health and Education Act of 1994

Forbids manufacture or distribution of these

products to make anyadvertising or labeling claims
that indicates that the use of the product can
prevent or cure any disease

The product is not intended to diagnose, treat , cure

or prevent any disease
The FDA and the Food and Drug Administration Modernization Act

Enforce Federal Food, Drug and Cosmetic Act with

additional responsibility in enforcing many
additional pieces of legislation
 Code of Federal Regulations and Federal Register

Consists of 8 volumes containing all regulations

issued under the Federal Food, Drug and Cosmetic
Act and other statutes administered by the FDA
9th volume regulation issued under statutes issued
by the DEA
 Drug Product Recall

If the FDA or manufacturer finds that a marketed

product presents a threat or potential threat to
consumer safety product maybe recalled.