Transcript FEDERAL REGULATIONS OF MEDICATIONS

FEDERAL
REGULATIONS OF
MEDICATIONS
Food, Drug and Cosmetic Act
Protect consumers from adulterated and
misbranded foods, drugs, cosmetics, or
devices
FOOD
 Articles used for food and drink
 Chewing gum
 Articles used for components of any
such article
DRUG
 Listed in USP, Homoeopathic
Pharmacopeia of US, NF or
supplements
 Intended for use in





Diagnosis
Cure
Mitigation
Treatment
Prevention
DRUG (cont)
 Intended to affect structure or function of
body
 Intended for use as a component of the
others
 Achieve intended purpose through
chemical action
DEVICE
 Listed in USP, NF, or supplements
 Intended





Diagnosis of disease or other conditions
Cure
Mitigation
Treatment
Prevention
DEVICE (cont)
 Intended to affect structure or function
 Does not achieve primary intended
purposes through chemical action and is
not dependent on being metabolized
LABEL
Written, printed, or graphic matter upon the
immediate container of any article
LABELING
 All labels
 Other written, printed, or graphic matters
upon article or any of its containers or
wrappers
 Material accompanying such article
ADULTERATION
 Consists of any filthy, putrid, or decomposed





substance
Prepared or held under unsanitary conditions
Does not meet CGMP
Varies from USP standards
Contains unapproved color additive
Container leaks or causes drug decomposition
MISBRANDING
 Labeling is false or misleading
 Drug is subject to deterioration, unless
label states precautions
 Drug is subject to but not packaged
according to Poison Packaging Act
 Dispensing of non FDA approved drug
 Dispense Rx drugs or refill without
authorization or prescription
NEW DRUG APPROVAL
 “New drug”

NDA approved by FDA
 Reports
showing drug’ safety and efficacy
 Drug’s components and composition
 Methods, facilities, and controls used
 Samples of the drug and its components
 Proposed labeling of the drug
NEW DRUG TESTING (IND)
 Phase I (to detect adverse effects)


Small number of people
Examines
 Toxicity
 Metabolism
 Bioavailability
 Elimination
 Other
pharmacologic activities
NEW DRUG TESTING (Cont)
 Phase II (determine efficacy and
dosages)


Patients with the disease
Continue pharmacological testing to
ensure safety
NEW DRUG TESTING (Cont)
 Phase III


Given to large numbers of patients to
further determine safety and efficacy
If successful may submit NDA
OTC LABEL
 1. The name of the product;
 2. The name and address of the manufacturer, packer, or





distributor;
3. The net contents of the package;
4. The established name of all active ingredients, and the
quantity of certain other ingredients whether active or not;
5. The name of any habit-forming drug contained in the
preparation;
6. Cautions and warnings needed for the protection of the
user; and
7. Adequate directions for safe and effective use.
Rx DRUG
A statement of the drug’s identity in terms of its established name and
quantity and portion of each active ingredient.
2 A declaration of net quantity.
3 A statement of the usual dosage.
4 The federal caution legend.
5 The route of administration if it is not for oral use.
6 If it is a habit forming drug, the federal warning, “Warning: May be
habit forming.”
7 If other than oral use, the names of all inactive ingredientsexceptions are made for flavorings, perfumes, and color
additives.
8 An identifying lot or control number.
9 A statement to the pharmacist specifying the type of container to be
used in dispensing.
10 The name and place of business of the manufacturer, packer, or
distributor.
11 The expiration date unless exempted.
1
Rx DRUG LABELING
1 Description
2 Clinical pharmacology
3 Indications and usage
4 Contraindications
5 Warnings
6 Precautions
7 Adverse reactions
8 Drug abuse and dependence
9 Overdosage
10 Dosage and administration
11 How supplied
DURHAM-HUMPHREY AMENDMENT OF 1951




Only upon the written prescription of a physician
licensed by law to administer such drugs;
Upon the physician’s oral prescription, which is
reduced promptly to writing and filled by the
pharmacist;
By refilling a written or oral prescription if the refill is
authorized by the prescriber either on the original
prescription or orally and then reduced to writing
and filled by the pharmacist; or
By administration (dispensing) directly by the
physician.
KEFAUVER-HARRIS AMENDMENTS OF 1962
Before marketing any new drug, manufacturers were required to
supply: a) proof of safety, and b) proof of effectiveness.
 Current Good Manufacturing Practices, the so-called CGMP,
were established, and if a manufacturer produced a drug
without adhering to such practices, that drug was considered
adulterated.
 Prescription drug advertising was placed under the supervision
of the FDA, while the Federal Trade Commission (FTC)
continued to supervise the advertising of OTC items.
 The amendments established a procedure for new drug
applications and for investigational drug procedures which
required assurances of the informed consent of the research
subjects and required reporting of adverse drug reactions.
Qualifications of drug investigators were subject to review.

MEDICAL DEVICE AMENDMENT OF 1976
 All medical devices in Classes I, II, or III,
on the basis of the risk
 Class III devices are subject to premarket approval.
ORPHAN DRUG ACT OF 1983
 Provides tax incentives and a limited exclusive
license (7 years) to manufacturers of drugs for
rare diseases or conditions
 A rare disease or condition is one that affects
less than 200,000 persons in the U. S
 One that affects more than 200,000 persons in
the U. S. and for which there is no reasonable
expectation of recovering the development
costs
DRUG PRICE COMPETITION AND PATENT
TERM RESTORATION ACT OF 1984
 Extended the ANDA process to include
generic versions of all post-1962
approved drugs, except antibiotics,
which already had a generic approval
process in place
 Act permits extension of patent life
PRESCRIPTION DRUG MARKETING ACT OF
1987
 Reduce the potential public health risks that
may result from diversion of prescription drugs
from legitimate commercial channels
 States license wholesale distributors
 The reimportation of prescription drugs
produced in the U. S. is banned
 It also bans sale, trade or purchase of drug
samples and the trafficking in and counterfeiting
of drug coupons