Professional Documents
Culture Documents
6675
September 13,1988
DEFINITION OF TERMS
is the finished product form that contains the active ingredients ,
generally but not necessarily in association with inactive ingredients
DEFINITION OF TERMS
DEFINITION OF TERMS
DEFINITION OF TERMS
DEFINITION OF TERMS
DEFINITION OF TERMS
E.O. 49
A.O. 2012-0023
As amended:
(e) There shall be appear prominently on the label of a generic drug the
following statement: THIS PRODUCT HAS THE SAME THERAPEUTIC
EFFICACY AS ANY OTHER GENERIC PRODUCT OF THE SAME
NAME, SIGNED: BFAD.
1.
SEC
8. Required Production:
2.
THE GENERIC NAME MUST BE WRITTEN IN FULL BUT THE SALT OR CHEMICAL FORM MAY BE ABBREVIATED
3. THE GENERIC NAME OF THE DRUG ORDERED MUST BE CLEARLY WRITTEN ON THE
PRESCRIPTION IMMEDIATELY AFTER THE Rx SYMBOL, OR ON THE ORDER CHART
3.1. In addition to the generic name, a brand name may also be indicated. In such cases,
the following shall be observed:
3.1.1. If written on a prescription pad, the
brand name enclosed in parenthesis shall be
written below the generic name
3.1.2. If written on a patients chart, the
brand name enclosed in parenthesis shall be
written after the generic name
4. ONLY ONE DRUG SHALL BE PRESCRIBED
THINGS TO REMEMBER WHEN BUYING MEDICINES TO CHECK IF IT IS REGISTERED WITH BFAD-DOH AND IF IT
COMPLIES WITH GENERIC LABELING
Bottle/Box (Syrup, Tablet, Capsule, Injectable, Ointment)
- Generic name / Brand name
- Dosage strength / form
- Pharmacologic category
- Company logo
- Name / Address of company
- Rx symbol if prescription drugs
- Net content
Formulation
Indication / Dosage
Warning / contraindication / precaution
DR number
Expiry date
Batch number / Lot number
Manufacturing date
Storage condition
Two
CLASSIFICATION OF DRUGS
Shall be kept in file for two years & recorded in a Rx book duly registered by FDA
Shall be open for inspection to Food & Drug Inspectors at any time during business hours of the
outlet.
Rx book shall be kept for two years after the last entry
Pharmaceutical products or drug preparations that can be dispensed even without the
written order of a validly-registered
validly-registered licensed physician, dentist or veterinarian
for the use of consumers for the prevention or symptomatic relief of minor or self-limiting
ailments.
DANGEROUS DRUGS
Refer to:
Prohibited Drugs
Regulated Drugs
-
DANGEROUS DRUGS
Prohibited Drugs
Include:
Other drugs, natural or synthetic, with the physiological effects of a narcotic drug
DANGEROUS DRUGS
Prohibited Drugs
DANGEROUS DRUGS
Regulated Drugs
Include:
Sleep-inducing sedatives
- secobarbital, phenobarbital, barbital,
amobarbital
Hypnotic drugs
- methaqualone or any other compound producing
barbituric acid
similar to amphetamine
similar pharmacologic effects
DANGEROUS DRUGS
Regulated Drugs
DANGEROUS DRUGS
Regulated Drugs
Requirements in the dispensing & compounding of dangerous
drugs
List of Products
Use
List of Products
Use
List of Products
Use
List of Products
Use
List of Products
Use
DISPENSING
a prescription
GENERIC DISPENSING
means dispensing the patients/ buyers choice among the generic equivalents, i.e. finished
pharmaceutical products having the same active ingredient(s) same dosage form and same
strength as the prescribed drug
PARTIAL FILLING OF Rx
1 copy retained by the buyer or by the person to whom the drug is delivered until such drug is
consumed.
2nd copy shall be retained by the person issuing the prescription (Sec. 25, R.A. 6425, as amended)
Exercise 1
Prescription without specification on the Generic name of the prescribed
product is a violation of:
A. R.A. 5921
B. R.A. 3720
C. R.A. 6675
D. R.A. 8203
Exercise 2
An act to promote, require, and ensure the production of an adequate supply,
distribution, use and acceptance of drugs and medicines identified by their
generic names
A.
B.
C.
D.
R.A. 3720
R.A. 5921
R.A. 6675
R.A. 9502
Exercise 3
Sudafed 200 mg Tablet prescription is
A. Violative prescription
B. Erroneous prescription
C. Impossible prescription
D. Intentional prescription
Exercise 4
The objective of Generic Law is to
A. provide regulated drugs
B. use of habit forming drugs
C. provide prohibited drugs
D. provide the patient choice of the drug at the lowest cost
Exercise 5
Considered as violative Rx
A. Mefenamic (Ponstan)
B. Ibuprofen (Brufen)
C. Nystatin (Mycostatin)
D. Rx Loviscol