WHAT ARE DANGEROUS DRUGS ?  

Dangerous drugs include those listed in the Schedules annexed to the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, and in the Schedules annexed to the 1971 Single Convention on Psychotropic Substances as enumerated in the attached annex of RA9165.

 

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WHAT ARE THE CHEMICALS CONTROLLED UNDER RA 9165?

The controlled chemicals are the following:

TABLE I+ Table II+
ACETIC ANHYDRIDE ACETONE
N-ACETYLANTHRANILIC ACID ANTHRANILIC ACID
ERGOMETRINE ETHYL ETHER
ERGOTAMINE HYDROCHLORIC ACID
ISOSAFROLE METHYL ETHYL KETONE
LYSERGIC ACID PHENYL ACETIC ACID

3,4-METHYLENEDIOXYPHENYL-2 PROPANONE

PIPERIDINE
NOREPHEDRINE SULFURIC ACID
1-PHENYL-2-PROPANONE TOLUENE
PIPERONAL ** THIONYL CHLORIDE
POTASSIUM PERMANGANATE  
SAFROLE  
* PSEUDOEPHERDINE  
* EPHEDRINE  

 

* RECLASSIFIED AS DANGEROUS DRUGS PURSUANT TO B.R. NO. 4, S. 2005

** CLASSIFIED UNDER TABLE II PURSUANT TO B.R. NO. 5,S. 2005

+ THE SALTS OF THE SUBSTANCES LISTED IN THIS TABLE WHENEVER THE EXISTENCE OF SUCH SALTS IS POSSIBLE.

++ THE SALTS OF THE SUBSTANCES LISTED IN THIS TABLE WHENEVER THE EXISTENCE OF SUCH SALTS IS POSSIBLE.THE SALTS OF HYDROCHLORIC ACID AND SULFURIC ACID ARE SPECIFICALLY EXCLUDED.

 

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WHAT ARE THE LICENSES ISSUED AT THE COMPLIANCE SERVICE, PDEA, AND THE SCOPE OF COVERAGE OF EACH LICENSE WITH THE CORRESPONDING FEES?

The following are the dangerous drugs, dangerous drugs preparation/s, Table I controlled chemical/s used in the manufacture of drug preparation/s &/or their preparation/s categorized as S-LICENSE/S and the precursors and essential chemical/s or controlled chemical/s &/or mixture/s categorized as P-LICENSE/S that are issued at said Service:

 

1. For handlers of dangerous drug/s(DD) , dangerous drugs preparation/s(DDP/s), Table I Controlled Chemical/s used in the manufacture of drug preparation/s &/or their preparation/s (DP/s):
Category

Annual Fee (PhP)
S-1 Retail of DP/s containing Table I Controlled Chemical/s 500.00
S-3 Retail of DD/DDP/s & /or DP/s containing Table I Controlled Chemical/s 1,000.00
S-4 Wholesale/Distribution of DD/DDP/s/Table 1 Controlled Chemical/s used in the manufacture of drug preparation/s/ &/or their preparation/s 3,000.00
S-5 C Compounding/Manufacture of DD/ DDPs &/or D P/s containing Table I Controlled Chemical/s 5,000.00
S-5I Importation of DD/DDP/s /Table I Controlled Chemical/s used in the manufacture of drug preparation/s &/or their preparation/s 5,000.00
S-5E Exportation of DDP/s &/or D P/s containing Table I Controlled Chemical/s 5,000.00
S-5D Depot/Storage for S-4 & S-5 license holder (When such address is separate and distinct from the office address of the license holder) 5,000.00
S-6 License to conduct laboratory analysis or technical research using DD/DDPs &/or DP/s 500.00
 

2.For handlers of Precursors and Essential Chemical/s or Controlled Chemical/s &/ or mixture/s (PECS)
Category

Annual Fee (PhP)
P-1 Retail of Precursor & Essential Chemicals ( PECS) &/or mixture/s 500.00
P-3 End-Use of PECS &/or mixture/s 2,500.00
P-4 Wholesale/Distribution/Trading of PECS&/or mixture/s 3,000.00
P-5-C Compounding/Manufacture/Repack/Recycling of PECS &/or mixture/s 5,000.00
P-5-D Bulk Depot/Storage for P4 & P5-Holders ( Such location is deemed separate& distinct from the office address of the license holder) 3,000.00
P-5-E Exportation of PECS &/or mixture/s 5,000.00
P-5-I Importation of PECS &/or mixture/s 5,000.00
P-5-IM Importation of PECS to End-Use 5,000.00
P-6 License to conduct laboratory analysis or technical research using PECS 500.00
 
3. For Practitioners (Physician, Dentist, Veterinarian)
Category Annual Fee (PhP)
S-2 License to prescribe DD/DDPs, &/or DP/s containing Table I Controlled Chemical/s

 

 

WHAT ARE THE REQUIREMENTS IN THE APPLICATION OF S-1, S-3, S-4, S-5C, S5I, S-5E, S-5D, AND S-6 LICENSES?

 

THE REQUIREMENTS FOR RENEWAL APPLICATION ARE:

A. BFAD LICENSE to OPERATE with current official receipt;

B. Current Mayor’s Permit with official receipt;

C. Current Professional Regulation Commission (PRC) Card of Authorized Pharmacist;

D. Current Professional Tax Receipt of Authorized Pharmacist. For government employed- latest certification of employment ;

E. Current DTI Certificate of Registration of Business Name /Securities & Exchange Commission Registration;

F. Semi-annual report/Record Book ;

G. NBI Clearances of either the Owner or President or General Manager (GM), or Branch Manager (BM) or Hospital Director (HD) (whoever is the head of the company) & Authorized Pharmacist);

H. Projected importation (for importer only )/ Manufacturing quota (for manufacturers of DDP/s,DP/s only);

I. Previous License to Handle (LTH) DD/DDP/s, Table I Controlled Chemical/s/DP/s &/or official Receipt .

 

REQUIREMENTS FOR NEW APPLICATION:

A. BFAD LICENSE to OPERATE with current official receipt;

B. Current Mayor’s Permit with official receipt;

C. Current Professional Regulation Commission (PRC) Card of Authorized Pharmacist;

D. Current Professional Tax Receipt of Authorized Pharmacist. For government employed- latest certification of employment ;

E. Current DTI Certificate of Registration of Business Name /Securities & Exchange Commission Registration;

F. NBI Clearances of either the Owner or President or General Manager (GM), or Branch Manager (BM) or Hospital Director (HD) (whoever is the head of the company) & Authorized Pharmacist);

G. Projected importation (for importer only )/ Manufacturing quota (for manufacturers of DDP/s,DP/s only);

H. Letter of Authorization from the Owner/President/ General Manager or Hospital Director for the Authorized Pharmacist to handle and transact business in DD/ DP/s / Table I Controlled Chemical/s used in the manufacture of drug reparation/s &/or their preparation/s;

I. Sworn Statement of Authorized Pharmacist re compliance to RA 9165 & its implementing regulations ;

J. TIN(Establishment & Owner/President or GM or BM or HD & Authorized Pharmacist);

K. Company Profile;

L. Floor Plan / lay-out indicating exact location of storage area ;

M. Location / vicinity map of the company;

N. Proof of ownership of land/ building /Contract of Lease;

O. Front view pictures of the establishment showing the signage & storage area for DD/DDP/s/Table I
P. Controlled Chemical/s used in the manufacture of drug preparation/s &/or their preparation/s showing the security locks;
Q. Photocopy of Company ID of the owner/President/GM or BM & the Authorized Pharmacist; One (1) 2 X 2 ID picture & (3)specimen signatures of the Owner or President or GM or BM or HD & Authorized Pharmacist.

 

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