WEEK 16 emehn

• Center for Drug Regulation and Research

• Center for Food Regulation and Research

• Center for Cosmetics Regulation and Research

• Center for Device Regulation, Radiation Health, and Research

FDA ACT OF 2009 ORGANIZATION

lifetime imprisonment

5 to 10 Million

PENALTY in dangerous drug act

• social pension

• mandatory PhilHealth Coverage

• Social Safety nets

COVERAGE OF RA 9994

Social Pension

"Indigent senior citizens shall be entitled to a monthly stipend amounting to Five hundred pesos (Php500.00) to augment the daily subsistence and other medical needs of senior citizens, subject to a review every two (2) years by Congress, in consultation with the DSWD.

Mandatory PhilHealth Coverage

All indigent senior citizens shall be covered by the national health insurance program of PhilHealth.

• allocate the necessary funds to ensure the enrollment of their indigent senior citizens in accordance with the pertinent laws and regulations.

Social Safety Nets

intended to cushion the effects of economic shocks, disasters, and calamities shall be available for senior citizens.

Licensing and Registration Division

which shall be responsible for evaluating health products and establishments as covered by this Act for the purpose of issuance of authorizations and conditions to be observed;

Product Research and Standards Development Division,

which shall be responsible for the conduct of research, development of standards and regulations, compliance monitoring, and the oversight and audit of related researches that would ensure safety, quality, purity and efficacy of health products, as covered in this Act

Laboratory Support Division

responsible for the conduct of research and appropriate tests and calibration, analyses and trials of product,s including, but not limited to, assays, and the conduct of oversight and/or audit of centers conducting bioavailability and bioequivalence tests and other tests as covered by this Act.

• Possession 

• Manufacture, sale, donate, import 

• Import a banned product

Prohibited in SPECIAL LAW ON COUNTERFEIT DRUG

• Certificate – import and export 

• Present duplicates showing purchase or import or export

• Drugs must not appear to be counterfeit

Exempted of liability in SPECIAL LAW ON COUNTERFEIT DRUG

100,000php to 500,000php

HOW MUCH THE PENALTY in SPECIAL LAW ON COUNTERFEIT DRUG

• Permanent closure 

• Revocation of LTO

• Fine 100,000php to 500,000php

• Forfeit, confiscate, destroy products

• Filing of appropriate proceeding against registered RPh with PRC – cancellation of license

• Criminal charges and permanent disqualification from owning or operating any business activity

PENALTIES in SPECIAL LAW ON COUNTERFEIT DRUG

4 TO 6

WHAT class municipal health unit in CATEGORY B

1 TO 3

WHAT class municipal health unit in CATEGORY A

IV

WHAT ARTICLE of REGULATION OF THE PRACTICE OF PHARMACY

REGULATION OF THE PRACTICE OF PHARMACY

ARTICLE IV?

twenty-four (24) hours

 report shall be made to the supervising pharmacist within WHAT TIME?

CATEGORY A

direct and immediate control and supervision of a duly registered and licensed pharmacist is required

CATEGORY A

establishment may be allowed to simultaneously work or render pharmacy services

CATEGORY B

supervision and oversight of a duly registered and licensed pharmacist is required

CATEGORY B

establishments, the maximum number of hours of which shall be determined, in accordance with such guidelines as may be established therefore by the Board,

Satellite institutional pharmacies

providing medicines solely to employees of their respective companies or the employees

2 years

when the pharmacy is open, and must be kept for a period of not less than HOW MANY YEARS after the last entry^?

Republic Act No. 9165

Section 37,

pharmacy shall be recorded in the Dangerous Drugs Book or an equivalent recording system as required by