EXP. 2 LAWS RELATED TO DRUG DISPENSING Flashcards
THE PHARMACY LAW
RA 10918 (RA 5921)
THE FOODS, DRUGS, DEVICES AND COSMETIC ACT
RA 3720
SPECIAL LAW ON COUNTERFEIT DRUGS
RA 8203
THE GENERICS ACT OF 1988
RA 6675
COMPREHENSIVE DANGEROUS DRUG ACT OF 2002
RA 9165
EXPANDED SENIOR CITIZEN ACT
RA 9994
CONSUMERS ACT
RA 7394
UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY MEDICINES ACT
OF 2008
RA 9502
ENUMERATE THE 2 FDA CIRCULAR’S AND 3 A.O. NO.’S
FDA CIRCULAR NO. 2014-025
FDA CIRCULAR NO. 2014-028 A.O. NO. 2013-0027
A.O. NO. 2016 – 0003
A.O. NO. 220 S. 1974
This law is the reason why we have FDA
RA 3720 - FOODS, DRUGS
AND DEVICES, AND
COSMETICS ACT
AN ACT TO ENSURE THE SAFETY AND PURITY OF
FOODS, DRUGS AND COSMETICS BEING MADE
AVAILABLE TO THE PUBLIC BY CREATING THE
FOOD AND DRUG ADMINISTRATION WHICH
SHALL ADMINISTER AND ENFORCE THE LAWS
PERTAINING THERETO.
RA 3720 - FOODS, DRUGS
AND DEVICES, AND
COSMETICS ACT
ADULTERED FOOD OR MISBRANDED FOOD
- IF IT BEARS OR
CONTAINS ANY POISONOUS OR DELETERIOUS
SUBSTANCE WHICH MAY RENDER IT INJURIOUS TO HEALTH - IT IS NOT ADULTERATED IF THE QUANTITY IS NOT ____TO BE
INJURIOUS
ADULTERATED FOOD
ENOUGH
ADULTERED FOOD OR MISBRANDED FOOD
- IT BEARS OR CONTAINS ANY ADDED POISONOUS OR ADDED
DELETERIOUS SUBSTANCE - EXCEPT_____
ADULTERATED FOOD
PESTICIDES
ADULTERED FOOD OR MISBRANDED FOOD
IT CONSISTS IN WHOLE OR IN PART OF ANY FILTHY, PUTRID, OR IN
PART DECOMPOSED SUBSTANCE, OR IF IT IS OTHERWISE
FOR FOOD
ADULTERATED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
IT HAS BEEN PREPARED, PACKED, OR HELD UNDER UNSANITARY
CONDITIONS
ADULTERATED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
IT IS A PRODUCT OF A DECEASED ANIMAL
ADULTERATED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
CONTAINER IS COMPOSED OF ANY POISONOUS OR
DELETERIOUS SUBSTANCE
ADULTERATED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
ANY VALUABLE CONSTITUENT HAS BEEN, IN WHOLE OR IN PART
OMITTED OR ABSTRACTED
ADULTERATED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
ANY SUBSTANCE INJURIOUS TO HEALTH HAS BEEN ADDED
ADULTERATED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
DAMAGE OR INFERIORITY HAS BEEN CONCEALED IN ANY MANNER
ADULTERATED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
ANY SUBSTANCE HAS BEEN SO AS TO INCREASE ITS BULK OR WEIGHT,
OR REDUCE ITS QUALITY OR STRENGTH, OR MAKE
IT APPEAR BETTER
OR
OF GREATER VALUE
ADULTERATED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
.IT BEARS OR CONTAINS A _____ COLOR OTHER THAN
ONE WHICH IS PERMISSIBLE
ADULTERATED FOOD
COAL-TAR
ADULTERED FOOD OR MISBRANDED FOOD
IT IS A -CONFECTIONARY
, AND IT BEARS OR CONTAINS ANY
ALCOHOL OR NON-NUTRITIVE ARTICLES OR SUBSTANCE
* EXCEPT______,______
ADULTERATED FOOD
HARMLESS COLORING, HARMLESS FLAVORING
ADULTERED FOOD OR MISBRANDED FOOD
IT IS OLEOMARGARINE OR MARGARINE
OR BUTTER
AND ANY OF
THE RAW MATERIAL USED IS FILTHY, PUTRID OR DECOMPOSED
ADULTERATED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
ITS LABELING
IS FALSE OR MISLEADING
MISBRANDED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
IT IS OFFERED FOR SALE
UNDER THE NAME OF ANOTHER
FOOD
MISBRANDED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
IT IS AN IMITATION OF ANOTHER FOOD
1. EXCEPT IF WITH THE WORD ______
MISBRANDED FOOD
“IMITATION”
ADULTERED FOOD OR MISBRANDED FOOD
CONTAINER IS SO MADE AS TO BE MISLEADING
MISBRANDED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
IF IN PACKAGE FORM
* UNLESS LABEL CONTAINS
1.
2.
MISBRANDED FOOD
- NAME AND PLACE OF MANUFACTURER
- ACCURATE STATEMENT OF CONTENTS
ADULTERED FOOD OR MISBRANDED FOOD
IF ANY WORD REQUIRED BY OR UNDER AUTHORITY OF THE ACT TO APPEAR ON
THE LABEL OR LABELING IS NOT PROMINENTLY PLACED
MISBRANDED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
IF IT PURPORTS TO BE FOOD
1. UNLESS IT CONFORMS TO SUCH DEFINITION AND STANDARD
2. ITS LABEL BEARS THE NAME OF THE FOOD SPECIFIED IN
THE DEFINITION AND STANDARD
MISBRANDED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
IF IT PURPORTS TO BE FOOD
1. BUT QUALITY FALLS BELOW SUCH FOOD UNLESS LABEL BEARS
2. BUT STANDARDS OF FILL FALLS BELOW UNLESS LABEL BEARS
MISBRANDED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
IF NOT SUBJECT TO THE ABOVE PROVISIONS UNLESS ITS LABEL
BEARS
1. USUAL NAME OF THE FOOD
2. USUAL NAME OF EACH SUCH INGREDIENT; EXCEPT THE SPICES, FLAVORING
AND COLORINGS
MISBRANDED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
PURPORTS TO BE OR IS PRESENTED FOR SPECIAL DIETARY
USE, UNLESS ITS LABEL BEARS SUCH INFORMATION
MISBRANDED FOOD
ADULTERED FOOD OR MISBRANDED FOOD
IF IT BEARS OR CONTAINS ANY ARTIFICIAL FLAVORING,
ARTIFICIAL COLORING, OR CHEMICAL PRESERVATIVE,
UNLESS IT BEARS
MISBRANDED FOOD
When was RA 9165 – COMPREHENSIVE
DANGEROUS DRUG ACT OF 2002 signed into law?
June 7, 2002
safeguard or to protect the integrity of its territory and the well being of its citizens especially the youth
from the harmful effects of drugs
RA 9165 – COMPREHENSIVE
DANGEROUS DRUG ACT OF 2002
RA 9165 – COMPREHENSIVE
DANGEROUS DRUG ACT OF 2002
AN ACT INSTITUTING THE
COMPREHENSIVE DANGEROUS DRUGS
ACT OF 2002, REPEALING REPUBLIC ACT
NO. _____, OTHERWISE KNOWN AS THE
______, AS
AMENDED, PROVIDING FUNDS
THEREFOR, AND FOR OTHER PURPOSES
6425
DANGEROUS DRUGS ACT OF 1972
AS BASED ON WHO DEFINITION,
IT IS A CLUSTER OF PHYSIOLOGICAL, BEHAVIORAL AND COGNITIVE PHENOMENA OF VARIABLE INTENSITY, IN
WHICH THE USE OF PSYCHOACTIVE DRUG TAKES ON A HIGH PRIORITY THEREBY INVOLVING, AMONG OTHERS,
A STRONG DESIRE OR A SENSE OF COMPULSION TO
TAKE THE SUBSTANCE AND THE DIFFICULTIES IN
CONTROLLING SUBSTANCE-TAKING BEHAVIOR IN
TERMS OF ITS ONSET, TERMINATION OR LEVELS OF USE
DRUG DEPENDENCE
if you stop taking drugs, you will not function physiologically well
DRUG DEPENDENCE
ANY PERSON WHO SELLS, TRADES,
ADMINISTERS, DISPENSES, DELIVERS OR GIVES AWAY
TO ANOTHER, ON ANY TERMS WHATSOEVER, OR
DISTRIBUTES, DISPATCHES IN TRANSIT OR TRANSPORTS
DANGEROUS DRUGS OR WHO ACTS AS A BROKER IN
ANY OF SUCH TRANSACTIONS, IN VIOLATION OF THIS
ACT
PUSHER
you cannot stop the
medication even though you know
that it is more harmful than
beneficial
DRUG ADDICTION
ANY ACT OF GIVING AWAY ANY
DANGEROUS DRUG AND/OR
CONTROLLED PRECURSOR AND
ESSENTIAL CHEMICAL WHETHER FOR
MONEY OR ANY OTHER CONSIDERATION
SELL
ANY ACT OF INJECTING
INTRAVENOUSLY OR INTRAMUSCULARLY,
OF CONSUMING EITHER BY CHEWING,
SMOKING, SNIFFING, EATING,
SWALLOWING, DRINKING OR
OTHERWISE INTRODUCING INTO THE
PHYSIOLOGICAL SYSTEM OF THE BODY,
ANY OF DANGEROUS DRUGS
USE
e.g. when there are lot of available drugs but gave a regulated drug
UNNECESSARY PRESCRIPTIONS
e.g. giving a dangerous drug because they just want to
UNLAWFUL PRESCRIPTIONS
AN ACT OF PROHIBITING COUNTERFEIT DRUGS,
PROVIDING PENALTIES FOR VIOLATIONS AND
APPROPRIATING FUNDS.
RA 8203 – SPECIAL LAW ON
COUNTERFEIT DRUGS
MEDICINAL PRODUCT WITH THE
CORRECT INGREDIENTS BUT NOT IN THE AMOUNTS AS
PROVIDED HEREUNDER, WRONG INGREDIENTS, WITHOUT
ACTIVE INGREDIENTS, WITH INSUFFICIENT QUANTITY OF
ACTIVE INGREDIENT, WHICH RESULTS IN THE REDUCTION
OF THE DRUG’S SAFETY, EFFICACY, QUALITY, STRENGTH
OR PURITY
COUNTERFEIT DRUG
equipments used for capsules
PUNCH, DYE, PLATE
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.
RA 6675 – GENERICS ACT OF
1988
IS THE IDENTIFICATION OF DRUGS AND MEDICINES BY THEIR
SCIENTIFICALLY AND INTERNATIONALLY RECOGNIZED AI OR BY
THEIR OFFICIAL GENERIC NAME AS DETERMINED BY BFAD
GENERIC NAME
IS THE DESCRIPTION OF THE CHEMICAL STRUCTURE OF THE DRUG
OR MEDICINE AND SERVES AS THE COMPLETE IDENTIFICATION OF
A COMPOUND
CHEMICAL NAME
IS THE PROPRIETARY NAME GIVEN BY THE MANUFACTURER TO
DISTINGUISH ITS PRODUCTS FROM THOSE OF COMPETITORS
BRAND NAME
THE POLICY OF THE STATES TO PROTECT THE
INTEREST OF THE CONSUMER, PROMOTE HIS
GENERAL WELFARE AND TO ESTABLISH
STANDARDS OF CONDUCT FOR BUSINESS AND
INDUSTRY.
RA 7394 – CONSUMER ACT OF
THE PHILIPPINES
EVERY PRODUCERS SHOULD LABEL THEIR
PRODUCTS IF THOSE ARE?
HAZARDOUS OR
DANGEROUS.
BANNED HAZARDOUS PRODUCTS BUT
STILL DELIVERED BY PRODUCERS ARE
STRICTLY?
PROHIBITED
AN ACT GRANTING ADDITIONAL
BENEFITS AND PRIVILEGES TO SENIOR
CITIZENS, FURTHER AMENDING RA ______
AS AMENDED, OTHERWISE KNOWN AS
“AN ACT TO MAXIMIZE THE
CONTRIBUTION OF SENIOR CITIZENS TO
NATION BUILDING, GRANT BENEFITS AND
SPECIAL PRIVILEGES AND FOR OTHER
PURPOSES.
RA 9994 – EXPANDED SENIOR
CITIZEN ACT
7432
REFER TO ANY RESIDENT
CITIZEN OF THE PHILIPPINES WHO IS AT
LEAST 60 YEARS OLD.
SENIOR CITIZENS
REFER TO THE BRANCH OF
MEDICAL SCIENCE DEVOTED TO THE STUDY
OF THE BIOLOGICAL AND PHYSICAL
CHANGES AND THE DISEASES OF OLD AGE.
GERIATRICS
Discount and total Vat % exemption of Senior Citizens
20% & 12%
AN ACT PROVIDING FOR CHEAPER AND
QUALITY MEDICINES, AMENDING FOR THE
PURPOSE REPUBLIC ACT NO. 8293 OR THE
INTELLECTUAL PROPERTY CODE, REPUBLIC ACT
NO. 6675 OR THE GENERICS ACT OF 1988,
AND REPUBLIC ACT NO. 5921 OR THE
PHARMACY LAW, AND FOR OTHER PURPOSES
RA 9502 UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY MEDICINES ACT
OF 2008
AN ACT REGULATING AND MODERNIZING
THE PRACTICE OF PHARMACY IN THE
PHILIPPINES, REPEALING FOR THE PURPOSE
REPUBLIC ACT NUMBERED FIVE THOUSAND
NINE HUNDRED TWENTY-ONE (R.A. NO.
5921), OTHERWISE KNOWN AS THE ?
RA 10918
PHARMACY LAW
When is the RA 10918
PHARMACY LAW signed in to law?
July 21, 2018 - it is already recognized as new “Pharmacy Law”
THE STANDARDIZATION AND REGULATION OF
PHARMACEUTICAL EDUCATION
RA 10918
PHILIPPINE PHARMACY ACT
DEVELOPMENT AND ENHANCEMENT OF
PROFESSIONAL COMPETENCE OF PHARMACISTS
THROUGH CONTINUING PROFESSIONAL
DEVELOPMENT, RESEARCH, AND OTHER RELATED
ACTIVITIES
RA 10918
PHILIPPINE PHARMACY ACT
INTEGRATION OF THE PHARMACY PROFESSION
RA 10918
PHILIPPINE PHARMACY ACT
____PHARMACEUTICAL PRODUCT, OF WHATEVER NATURE AND
KIND, SHALL BE COMPOUNDED, DISPENSED, SOLD OR RESOLD, OR
OTHERWISE BE MADE AVAILABLE TO THE CONSUMING PUBLIC,
EXCEPT THROUGH A RETAIL DRUG OUTLET DULY LICENSED BY THE
FDA.
NO
SHALL BE DISPENSED ONLY WITH A
VALID PRESCRIPTION OF A PHYSICIAN, DENTIST, OR
VETERINARIAN.
PRESCRIPTION MEDICINES
SHALL BE DISPENSED ONLY BY A PHARMACIST,
EXCEPT IN EMERGENCY CASES WHERE THE SERVICES OF A
PHARMACIST ARE NOT AVAILABLE, AND IN SITUATIONS IN
ACCORDANCE WITH THE PROVISIONS IN SECTION 31 (B)
(2),(3). IN WHICH CASE, A DULY CERTIFIED PHARMACY
ASSISTANT OR PHARMACY TECHNICIAN MAY DISPENSE THE
MEDICINE.
PRESCRIPTION DRUGS AND PHARMACIST-ONLY OTC
MEDICINES
SHALL BE DONE ONLY BY
A PHARMACIST, IN ACCORDANCE WITH APPROPRIATE
GUIDELINES.
PATIENT COUNSELING, COMPOUNDING AND DISPENSING
GUIDELINES ON THE IMPLEMENTATION OF
NEW RULES AND REGULATIONS ON THE
LICENSING OF
DRUGSTORE/PHARMACY/BOTICA AND
SIMILAR OUTLETS FOLLOWING
ADMINISTRATIVE ORDER NO. 2014-003
FDA CIRCULAR NO. 2014-025
FDA CIRCULAR NO. 2014-025 IS DATED?
OCTOBER 2014
GUIDELINES ON THE IMPLEMENTATION OF
NEW RULES AND REGULATIONS ON THE
LICENSING OF RETAIL OUTLETS FOR NON
PRESCRIPTIONS DRUGS (RONPDS)
FOLLOWING ADMINISTRATIVE ORDER NO.
2014-0034
FDA CIRCULAR NO. 2014-028
FDA CIRCULAR NO. 2014-028 is dated?
13 OCTOBER 2014
ADOPTION AND IMPLEMENTATION OF
THE WORLD HEALTH ORGANIZATION
ANNEX 5 GUIDE TO GOOD DISTRIBUTION
PRACTICES (GDP) FOR PHARMACEUTICAL
PRODUCTS, AND ANNEX 9 GUIDE TO
GOOD STORAGE PRACTICES FOR
PHARMACEUTICALS
A.O. NO. 2013-0027
GUIDELINES ON THE UNIFIED LICENSING
REQUIREMENTS AND PROCEDURES OF THE
FOOD AND DRUG ADMINISTRATION (FDA)
A.O. NO. 2016 - 0003
