Investigational
New Drug Application (IND
Clinical Trials
1.Phase 1 Small
Number (20-80 subjects) - Pharmacological Effects, Safety
2. Phase 2 Several Hundred Patients
- Effectiveness, Risks and Side effects<
3. Phase 3 Several Thousand
Patients Clinical Trials
4. Phase 4 Post Marketing Surveillance
ANDA
SNDA
Marketing New Drugs
NDC
Codes 10 digits
1234 5678 90
GMP’S
(good manufacturing practices)
Regulations
that apply to manufacturers
Adulteration
and Misbranding
Adulteration – The Kansas City pharmacist, expired drugs in Ohio, or just plain
old contaminated drugs.
Misbranding
– Something is missing, something is incorrect, etc
Labels
versus Labeling
Labels
are on the products.
Labeling
includes labels and all other printed and promotional materials. Have to be
approved by FDA.
Package
Inserts. (Labeling) 13 Categories of information in package inserts.
Identification
of solid dosage forms.
Every
tablet and capsule must be imprinted in some way.
Pregnancy
Warning Categories.
This
is considered off-label use.
It
is permitted if there is a rationale basis for it.
Cannot
be promoted by manufacturer.
Class
I Most Serious
Class
II Less Serious
Class
III No Problem
Difference
between a drug recall and FDA seizure. Can the FDA order a recall?
Expiration
date applies to Manufacturer.
Beyond
Use Dating applies to pharmacist.
This
means childproof containers.
Applies
to all oral solid dosage forms.
How
can patients waive the childproof containers?
How
does this affect refill processing? Can containers be used over?
Are
any drugs exempted from the PPPA?
Only
required for certain drugs.
Written
Documents in lay terms that explain the drug’s uses, side effects, dangers etc.
Must
accompany every dispensing.
Institutional
patients – every thirty days.
Orange
book. What are “A” rated drugs and “B” rated drugs?
Maintenance
Treatment –
Methadone
Maintenance-
Must
be given to the patient in oral liquid form.
Prescriptions
cannot be written for methadone for maintenance treatment.
Short
Term Detoxification Treatment
Long
Term Detoxification Treatment
Over the Counter (OTC) drugs.
Labeling
Requirements. – Seven Point: Label.
New
regulations now require “Drug Facts”.
Switching from Prescription Status to OTC status.
1.
NDA
2.
FDA grants
exemption
3.
Supplemental
NDA
4.
Nonprescription
Drug Advisory Committee advises that an ingredient is safe for OTC use.
Dietary Supplements
Dietary Supplement Health Education Act.
(DSHEA).
This law exempts health foods, supplements,
and herbal products from FDA controls for OTC and prescription drugs.
No efficacy requirement
No safety requirement.
Products do not have be manufactured
under GMP’S.
Labeling CANNOT claim to cure, treat, or
prevent disease.
Claims to affect bodily function are
permitted.
So “for the prostate” is OK. But “This
drug will cure an enlarged prostate.” Is not acceptable.