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flashcards Nehku_Cee
RA 8203
Special Law on Counterfeit Drugs
September 4, 1996
RA 8203 was approved
Counterfeit drugs
Net content is 80% lower than the label content
100,000-500,000
Administrative sanction for violators of counterfeit drugs
6-10 years
Imprisonment for administrative case of counterfeit drugs
Permanent closure, Revocation of LTO
Other punishments for administrative case for counterfeit drugs
100,000-500,000, 12-15 years
If counterfeit drug caused illness:
500,000-5 million, reclusion perpetua
If counterfeit drug caused death:
RA 5921
Pharmacy Law
June 23, 1969
Date approved of RA 5921
Ferdinand Marcos
President who signed RA 5921
Gil Puyat
Senate President who signed RA 5921
Corazon Aquino
President who enunciated National Drug Policy
Corazon Aquino
President who signed Generics Act of 1988
1 Chairperson and 2 Members
Composition of Board of Pharmacy
Anthony Aldrin Santiago
Chairperson of BOP
Mildred Oliveros and Adelina Royo
Members of BOP
3 yrs
No. of years the chairperson and members of BOP will hold office after appointment
6 months
Suspension for administrative offense of BOP member
10 days after receipt
No. of days to answer against formal complaint
5 years
Book of Poisons
1,000-4,000 and 6 months to 4 years
Penalty for false representation as pharmacist
RA 3720
Food, Drugs, Devices and Cosmetics Act
June 22, 1963
Date RA 3720 was signed
180 days
Duration of waiting for notice of an oppurtunity for a hearing after filing of an application for Licensing and registration of drugs or devices
5 years
Duration for LTO reapplication after revocation
1,000-5,000
Penalty Administrative fine for RA 3720
RA 9165
Comprehensive Dangerous Drugs Act
June 7, 2002
Date RA 9165 was signed
10 g
Morphine
500,000 to 10 million
Fine for morphine users
10 g
Heroin
10 g
Opium
10 g
Cocaine
50 g
Shabu
500 g
Marijuana
1 year
Dangerous drug prescription book
2 years
Ordinary prescription book
100 meters
Distance for school where dangerous drug transaction cause maximum penalty
Mandatory rehab
Penalty for first offense for drug use
Dangerous Drug Board
Advisory for drug use
PDEA
Enforcement agency of DDB
500,000-10 million and life imprisonment to death
Penalty for importing dangerous drug
Death penalty
Penalty for planting dangerous drug
AO 42
Drug registration of herbal and/or traditional drugs both local and imported
10%
Alcohol limit test for QC requirements
1 year
Validity of the initial registration of herbal and traditional drugs
1 year
Validity of the initial registration of LTO
AO 56
Revised rules and regulation for licensing of drug establishment
2 years
Renewal of LTO validity
FDA
Agency that approves LTO
AO 220
Prescribes GMP practice
2
No of people to check critical step in production process
RA 3720
Food, Drug and Cosmetics Act
PD 223
Creation of PRC
EO 851
Abolished FDA, created BFAD
RA 9165
Comprehensive Dangerous Drug Act
PD 881
Labeling, Sales and Distribution of Hazardous Substance
AO 56
Regulation for Licensing of Drug Establishments and Outlet
RA 6675
Generics Act
RA 7394
Consumer Act
RA 7432
Senior Citizens Act
RA 7581
Price Act
AO 42
Drug registration of herbal and/or traditional drugs both local and imported
AO 55
Labeling requirements for pharmaceutical products
AO 62
Generic prescribing
AO 63
Rules and regulations to implement dispensing requirements
AO 67
Revised rules and regulation of registration of pharmaceutical products
EO 226
Institutionalizes the continuing professional education
AO 220
Prescribing GMP practice applied to premises
September 4, 1996
Date of approval of RA 8203
June 23, 1969
Date of approval of RA 5921
June 22, 1963
Date of approval of RA 3720
June 7, 2002
Date of approval of RA 9165
April 13, 1992
Date of approval of RA 7394
April 23, 1992
Date of approval of RA 7432
FDA
Agency that approves LTO
AO 220
Prescribes GMP practice
2
No of people to check critical step in production process
RA 3720
Food, Drug and Cosmetics Act
PD 223
Creation of PRC
EO 851
Abolished FDA, created BFAD
RA 9165
Comprehensive Dangerous Drug Act
PD 881
Labeling, Sales and Distribution of Hazardous Substance
AO 56
Regulation for Licensing of Drug Establishments and Outlet
RA 6675
Generics Act
RA 7394
Consumer Act
RA 7432
Senior Citizens Act
RA 7581
Price Act
AO 42
Drug registration of herbal and/or traditional drugs both local and imported
AO 55
Labeling requirements for pharmaceutical products
AO 62
Generic prescribing
AO 63
Rules and regulations to implement dispensing requirements
AO 67
Revised rules and regulation of registration of pharmaceutical products
EO 226
Institutionalizes the continuing professional education
AO 220
Prescribing GMP practice applied to premises
September 4, 1996
Date of approval of RA 8203
June 23, 1969
Date of approval of RA 5921
June 22, 1963
Date of approval of RA 3720
June 7, 2002
Date of approval of RA 9165