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Companies and industries may apply for a Certification of Non-Controlled Products for substances not included in the list of dangerous drugs and Controlled Precursors and Essential Chemicals (CPECs) or Certificate of Exemption/Board Resolution for Exemption for products/ preparations/ chemical mixtures containing dangerous drugs and/or CPECs that are automatically exempted and/or above the Table of Concentration Limits. (see Table below)

Updated Lists /Scheduled Controlled Substances
as of 29 December 2017

CONTROLLED PRECURSORS AND ESSENTIAL CHEMICALS – include those listed in Table I and Table II of the 1988 UN Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances as at 18 October 2017

1988 United Nation Convention Against illicit Traffic
In Narcotic Drugs and Psychotropic Substance.

TABLE I

1 Acetic anhydride CAS NUMBER: 108-24-7
2 N-Acetylanthranilic acid CAS NUMBER: 89-52-1
3 Ephedrine (Reclassified as DD, Per DDB Reg. No. 4s. 2005) CAS NUMBER: 299-42-3
4 Ergometrine CAS NUMBER: 60-79-7
5 Ergotamine CAS NUMBER: 113-15-5
6 Isosafrole CAS NUMBER: 120-58-1
7 Lysergic acid CAS NUMBER: 82-58-6
8 3,4-Methylenedioxyphenyl-2-propanone CAS NUMBER: 4676-39-5
9 Norephedrine CAS NUMBER: 14838-15-4
10 4-Anilino-N-phenethylpiperidine (ANPP)  
11 N-Phenethyl-4-piperidone (NPP) CAS NUMBER: 14838-15-4
12 Phenylacetic acid (from Table II to Table I effective Jan. 2011) CAS NUMBER: 103-82-2
13 alpha-Phenylacetoacetonitrile (APAAN)  
14 1-Phenyl-2-propanone CAS NUMBER: 103-79-7
15 Piperonal CAS NUMBER: 103-79-7
16 Potassium permanganate CAS NUMBER: 7722-64-7
17 Pseudoephedrine (Reclassified as DD, Per DDB Reg. No. 4s. 2005) CAS NUMBER: 90-82-4
18 Safrole CAS NUMBER: 94-59-7

 

TABLE II

1 Acetone CAS NUMBER: 67-64-1
2 Anthranilic acid CAS NUMBER: 118-92-3
3 Ethyl ether CAS NUMBER: 60-29-17
4 Hydrochloric acid CAS NUMBER: 7647-01-0
5 Methyl ethyl ketone
Butanone
CAS NUMBER: 78-93-3
6 Piperidine CAS NUMBER: 110-89-4
7 Sulphuric acid CAS NUMBER: 7664-93-9
8 Toluene CAS NUMBER: 108-88-3

The salts of the substance listed in Tables I & II whenever the existence of such as salts is possible. (The salts of Hydrochloric acid and Sulfuric acid are specifically excluded)

 

1961 UNITED NATIONS SINGLE CONVENTION ON NARCOTIC DRUGS AS AMENDED BY THE 1972 PROTOCOL (56th edition, July 2017)

List of Drugs Included in Schedule 1

1 ACETORPHINE
2 ACETYL-ALPHA-METHYLFENTANYL
3 ACETYLFENTANYL
4 ACETYLMETHADOL
5 ALFENTANIL
6 AH-7921
7 ALLYLPRODINE
8 ALPHACETYLMETHADOL
9 ALPHAMEPRODINE
10 ALPHAMETHADOL
11 ALPHA-METHYLFENTANYL
12 ALPHA-METHYLTHIOFENTANYL
13 ALPHAPRODINE
14 ANILERIDINE
15 BENZETHIDINE
16 BENZYLMORPHINE
17 BETACETYLMETHADOL
18 BETA-HYDROXYFENTANYL
19 BETA-HYDROXY-3-METHYLFENTANYL
20 BETAMEPRODINE
21 BETAMETHADOL
22 BETAPRODINE
23 BEZITRAMIDE
24 BUTYRFENTANYL
25 CANNABIS
26 CANNABIS RESIN, EXTRACTS and TINCTURES
27 CLONITAZENE
28 COCA LEAF
29 COCAINE
30 CODOXIME
31 CONCENTRATE OF POPPY STRAW
32 DESOMORPHINE
33 DEXTROMORAMIDE
34 DIAMPROMIDE
35 DIETHYLTHIAMBUTENE
36 DIFENOXIN
37 DIHYDROETORPHINE
38 DIHYDROMORPHINE
39 DIMENOXADOL
40 DIMEPHEPTANOL
41 DIMETHYLTHIAMBUTENE
42 DIOXAPHETYL BUTYRATE
43 DIPHENOXYLATE
44 DIPIPANONE
45 DROTEBANOL
46 ECGONINE
47 ETHYLMETHYLTHIAMBUTENE
48 ETONITAZENE
49 ETORPHINE
50 ETOXERIDINE
51 FENTANYL
52 FURETHIDINE
53 HEROIN
54 HYDROCODONE
55 HYDROMORPHINOL
56 HYDROMORPHONE
57 HYDROXYPETHIDINE
58 ISOMETHADONE
59 KETOBEMIDONE
60 LEVOMETHORPHAN
61 LEVOMORAMIDE
62 LEVOPHENACYLMORPHAN
63 LEVORPHANOL
64 METAZOCINE
65 METHADONE
66 METHADONE INTERMEDIATE
67 METHYLDESORPHINE
68 METHYLDIHYDROMORPHINE
69 3-METHYLFENTANYL
70 3-METHYLTHIOFENTANYL
71 METOPON
72 MORAMIDE INTERMEDIATE
73 MORPHERIDINE
74 MORPHINE
75 MORPHINE METHOBROMIDE
76 MORPHINE-N-OXIDE
77 MPPP
78 MT- 45
79 MYROPHINE
80 NICOMORPHINE
81 NORACYMETHADOL
82 NORLEVORPHANOL
83 NORMETHADONE
84 NORMORPHINE
85 NORPIPANONE
86 OPIUM* (the coagulated juice of the opium poppy (plant species Papaver somniferum L.)
87 ORIPAVINE
88 OXYCODONE
89 OXYMORPHONE
90 PARA-FLUOROFENTANYL
91 PEPAP
92 PETHIDINE
93 PETHIDINE INTERMEDIATE A
94 PETHIDINE INTERMEDIATE B
95 PETHIDINE INTERMEDIATE C
96 PHENADOXONE
97 PHENAMPROMIDE
98 PHENAZOCINE
99 PHENOMORPHAN
100 PHENOPERIDINE
101 PIMINODINE
102 PIRITRAMIDE
103 PROHEPTAZINE
104 PROPERIDINE
105 RACEMETHORPHAN
106 RACEMORAMIDE
107 RACEMORPHAN
108 REMIFENTANIL
109 SUFENTANIL
110 THEBACON
111 THEBAINE (an alkaloid of opium; also found in Papaver bracteatum)
112 THIOFENTANYL
113 TILIDINE
114 TRIMEPERIDINE
115 U-47700

 

  • AND the isomers, unless specifically excepted, of the drugs in this Schedule whenever the existence of such isomers is possible within the specific chemical designation;
  • the esters and ethers, unless appearing in another Schedule, of the drugs in this Schedule whenever the existence of such esters or ethers is possible;
  • the salts of the drugs listed in this Schedule, including the salts of esters, ethers and isomers as provided above whenever the existence of such salts is possible

 

Dextromethorphan and dextrorphan are not under international control.

 

Narcotic Drugs Included in Schedule II of the 1961 Convention

 

1 ACETYLDIHYDROCODEINE
2 CODEINE
3 DEXTROPROPOXYPHENE
4 DIHYDROCODEINE
5 ETHYLMORPHINE
6 NICOCODINE
7 NICODICODINE
8 NORCODEINE
9 PHOLCODINE
10 PROPIRAM

 

  • AND the isomers, unless specifically excepted, of the drugs in this Schedule whenever the existence of such isomers is possible within the specific chemical designation;
  • the salts of the drugs listed in this Schedule, including the salts of the isomers as provided above whenever the existence of such salts is possible

 

For more information on the Updated Lists of Controlled Substances, click here.

 

REQUIREMENTS for CERTIFICATION (Non-controlled chemicals) and EXEMPTION (with controlled chemicals)

1. Application Form (AF) (Exemption / Certification)

2. Duly notarized Sworn Statement (SS) (Exemption / Certification)

3. Company Profile (CP) (FOR NEW APPLICANT ONLY)

4. Material Safety Data Sheet / or Safety Data Sheet (with complete CAS Number) (MS) or Certification from Supplier/s (for incomplete CAS) (CS) or Certificate of Analysis (complete assay for products with Controlled Chemicals) (CA)

5. Updated PDEA License as required (PL) (FOR EXEMPTION ONLY)

6. Formulation of the product (FP) (for manufacturers /compounders ONLY)

Note: Request for Certification and/or Exemption must be placed in CD or USB Flash Drive together with the complete requirements and in correct format/design (PDF WORD). A maximum of ten (10) items per request is allowed.

Example format: Company name_Document Type (Code)_date of Application (mmddyyyy)

Ex: JT Laboratory_MS_02042015_A (for application number 1)
JT Laboratory_MS_02042015_B (for application number 2)

If an application contains 10 products, indicate a number per MSDS at the end of the file name.

Ex: JT Laboratory_MS_02042015_A_1 (for product number 1 in the application)
JT Laboratory_MS_02042015_A_2 (for product number 2 in the application)

Document Type Code Example
1. Application Form AF JT Laboratory_AF_02042015
2. Sworn Statement SS JT Laboratory_SS_02042015
3. Company Profile CP JT Laboratory_CP_02042015
4a. MSDS MS JT Laboratory_MS_02042015

If more than one application, place letter A in the end of the file name.
JT Laboratory_MS_02042015_A (for application number 1)
JT Laboratory_MS_02042015_B (for application number 2)

If an application contains more than 10 chemicals, indicated a number per MSDS at the end of the file name.
JT Laboratory_MS_02042015_A_1 (for application number 1)
JT Laboratory_MS_02042015_A_2 (for application number 1)

Note: All MSDS should be converted to pdf format from MS office document

4b. Certificate from Supplier CS JT Laboratory_CS_02042015
4c. Certificate of Analysis CA JT Laboratory_CA_02042015
5. PDEA License PL JT Laboratory_PL_02042015
6. Formulation of product FP JT Laboratory_FP_02042015 (for manufacturers /compounders only)

Only Applications with complete requirements and in correct format will be accepted. Upon acceptance of application, a corresponding claim stub is issued.


Procedure

1. Present the CD or USB containing the complete documents in correct format to the DDB Legal officer for evaluation. If approve, a CLAIM STUB WILL BE AUTOMATICALLY ISSUED containing the Transaction Number of the application or request upon approval of the Pharmacist-in-Charge.
2. Application will then be processed. Processing time depends upon the number of items applied for.
3. Wait for the release of the approved Certification or Exemption. The status of the application may now be checked on-line using the Application for Certification and Exemption Database System (ACEDS).
4. Pay the corresponding Fee of P300.00 per request

"NO CLAIM STUB NO CERTIFICATION POLICY"

Substances in Table I and Table II of the 1988 Convention

Table I

Acetic anhydride

N-Acetylanthranilic acid

Ephedrine

Ergometrine

Ergotamine

Isosafrole

Lysergic acid

3,4-Mythylenedioxyphenyl-2-propanone

Norephedrine

Phenylacetic acid (from Table II to Table I effective Jan. 2011)

1-Phenyl-2-propanone

Piperonal

Potassium permanganate

Pseudoephedrine

Safrole

Table II

Acetone

Anthranilic acid

Ethyl ether

Hydrochloric acid

Methyl ethyl ketone

Piperidine

Sulphuric acid

Toluene