OUR LADY OF FATIMA UNIVERSITY
College of Pharmacy
LEGAL PHARMACY AND ETHICS (PLPE 311)
Week 13: Module 15
Generics Act of 1988,
RA 6675
UNIT OUTCOMES:
▷ Demonstrate knowledge on Generics Act of 1988
(RA 6675).
▷ Identify the laws that amends RA 6675.
▷ Identify the different prescription errors.
▷ Summarize the General Provisions, Statement of Policy,
and Important terms.
▷ Enumerate the Rules and Regulations, Prohibited Acts and
Penalties of RA 6675.
▷
2
UNIT OUTLINE:
Section 1. Title
Section 2. Statement of Policy
Section 3. Definition of Terms
Section 4. The Use of Generic Terminology for
Essential Drugs and Promotional Incentives
Section 5. Posting and Publication
UNIT OUTLINE:
Section 6. Who will use Generic Terminology
Section 7. Provision on Quality, Manufacturer’s
Identity and Responsibility.
Section 8. Required Production.
Section 9. Rules and Regulation.
Section 10. Authority to Import.
UNIT OUTLINE:
Section 11. Education Drive
Section 12. Penalty
CHECKLIST:
◎ Read required
course notes in RA
6675.
◎ Attend and
proact ively
part icipate on t he
Online Lect ure.
TERM INOLOGIES:
Generic Name / Generic Terminology
The identification of drugs and
medicines by their scientifically and
internationally recognized active
ingredients or by their official
generic name as determined by
the FDA of the Department of
Health.
TERM INOLOGIES:
Brand Name
The proprietary name
given by the
manufacturer to
distinguish its product
from those of
competitors.
NOTES:
GENERICS ACT OF 1988
RA 6675
GENERICS ACT OF 1988
RA 6675
A p p r ove d d at e :
September 13, 1988
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.
Section 2. Statement of Policy
To promote, encourage and require t he use of
gener ic ter minology
Section 2
To ensure t he
adequate supply of
dr ugs wit h gener ic
names at t he lowest
possible cost
Section 2
• To encourage the ex tensive use of drugs wit h gener ic names
t hrough
rat ional
system
of
procurement
and
dist r ibut ion
• To emphasize t he scient ific basis for t he use of dr ugs, in
order t hat healt h professionals may become more aware
and cogniz ant of t heir t herapeut ic ef fect iveness
• To promote dr ug saf et y by minimiz ing duplicat ion in
medicat ions and/or use of dr ugs wit h potent ially
adver se dr ug interact ions.
Section 4. The Use of Generic
Term inology for Essential Drugs and
Prom otional Incentives
I n t he promot ion of t he gener ic names for
phar maceut ical product s,special considerat ion
shall be given to dr ugs and medicines which
are included in t he Essent ial Dr ugs List.
Section 4.
The exclusive use of
gener ic ter minology in
t he manufact ure,
market ing and sales of
drugs and medicines,
part icular ly t hose in t he
Essent ial Dr ugs
List.
Section 5. Posting and Publication
The Depart ment of Healt h shall publish
annually in at least t wo (2) newspapers of
general circulat ion in t he Philippines t he
gener ic names, and t he cor responding brand
names under which t hey are marketed, of all
dr ugs and medicines availablein t he
Philippines.
Section 6. Who will use Generic Term inology
Section 6.
Any organiz at ion or company
involved in t he manufact ure,
importat ion, repacking, market ing
and/or dist r ibut ion of dr ugs and
medicines shall indicate prominent ly
t he gener ic name of t he product.
Section 7. Provision on Quality,
Manufacturer’s Identity and Responsibility.
Name and Country of
Manufacture
Dates of Manufacture and
Expiration
Section 8. Required Production.
S ubj ect to t he r ules and regulat ions
promulgated by t he S ecretar y of Healt h, ever y
dr ug manufact ur ing company operat ing in t he
Philippinesshall be required to produce,
dist r ibute and make available to t he general
public t he medicine it produces, in t he for m of
gener ic dr ugs.
Section 11. Education Drive
Section 12. Penalty
Any person who shall violate S ec.6 of t his Act shall:
st
1Convict ion
REPRIMAND
Section 12. Penalty
Any person who shall violate S ec.6 of t his Act shall:
nd
2
Convict ion
NLT P2,000.00 but
NMT P5,000.00
Section 12. Penalty
Any person who shall violate S ec.6 of t his Act shall:
3r d
Convict ion
NLT P5,000.00 but NMT
P10,000.00
S uspension for 30 days
Section 12. Penalty
Any person who shall violate S ec.6 of t his Act shall:
th
4
Convict ion
and
NLT P10,000.00
S uspension for 1 year or longer
Section 12.
Any j ur idical personwho violates S ec 6(c), 6 (d), 7
or 8 shall:
Penalt y:
NLT P5,000.00 but NMT
P10,000.00
And S uspension or
revocat ion of license to
operate
Section 12.
Any j ur idical personwho violates S ec 6(c), 6 (d), 7
or 8 shall:
Penalt y:
NLT P5,000.00 but NMT
P10,000.00
And S uspension or
revocat ion of license to
operate
Or impr isonment of NLT 6
mont hs NMT 1 year
Departm ent Memo 2009-0009
• Gener ics Only Prescr ibing
• Is sued on J anuar y 7, 2009
• This prohibit s gover nment physicians to
prescr ibe branded medicines.
•
A.O. 62 s. 1989
• S ubj ect : Rules and Regulat ions to I mplement
Prescr ibing Requirement s under RA 6675
Sec 3.
1. Gener ic names shall be used i n al l
pr escr i pt i ons.
2. The gener ic name must be w r i t t en i n f ul l
but t he salt may be abbreviated.
3. The gener ic name of t he dr ug must be
cl ear l y w r i t t en on t he prescr ipt ion
immediately after t he Rx symbol
Sec 4.
• I NCORRECT PRESCRI PTI ONS
1. Erroneous prescr ipt ion
2. Violat ive prescr ipt ion
3 . I mpossible prescr ipt ion
1. Erroneous prescr ipt ion
2. Violat ive prescr ipt ion
“NO S UBS TI TUTI ON”
3. I mpossible prescr ipt ion
A.O. 90 s. 1990
• S ubj ect : Amendment to A.O. 62 s. 1989
• Rules and Regulat ions to I mplement
Prescr ibing Requirement s
A.O. 90 s. 1990
• As amended A.O. 62,
per mit s t he wr it ingof
t he gener ic names of
more t han one dr ug
product in one
prescr ipt ion for m.
A.O. 63 s. 1989
• S ubj ect : Rules and Regulat ions to I mplement
Dispensing Requirement s under RA 6675.
Sec 4. Guidelines on what to do with
violative, erroneous, and im possible Rx
• Violat ive and impossible Rx .
• The prescr ipt ions shall be kept and reported
by t he phar macist or ot her interested
part ies to t he nearest DOH office for
appropr iate act ion.
Sec 4.
• Erroneous Rx
• The prescr ipt ions shall be filled, but it shall
also be kept and reported to t he nearest
DOH office for appropr iateact ion.
Sec 5. Violations on the part of dispensers
and outlets
• I mposing a part icular brand or product on
t he buyer
• I naccurate dispensing
• Failure to post or make accessible
required up- to- date info on dr ug product
• Failure to adequately infor m t he buyer
on available product s t hat meet
t he prescr ipt ion.
Sec 5. Violations on the part of dispensers
and outlets
• Failure to indicate t he gener ic name
• Failure to record and keep prescr ipt ions
filled.
• Failure to report to t he nearest DOH
office cases
of violat ive,
er roneous, and/or wrong prescr ipt ions
wit hin 3 mont hs after receipt
of such
prescr ipt ions.
Sec 5. Violations on the part of dispensers
and outlets
• Failure to report to t he nearest DOH office
cases of violat ive,er roneous, and/or wrong
prescr ipt ions wit hin 3 mont hs after receipt of
such prescr ipt ions.
REFERENCE:
◉ Tubon, N. (2018). Pharmaceutical
Jurisprudence and Ethics. Maxcor Publishing
House Inc.
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