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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 of Scheduled Controlled Substances
as of 28 June 2018

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 ACRYLOYFENTANYL (ACRYFENTANYL)
6 ALFENTANIL
7 AH-7921
8 ALLYLPRODINE
9 ALPHACETYLMETHADOL
10 ALPHAMEPRODINE
11 ALPHAMETHADOL
12 ALPHA-METHYLFENTANYL
13 ALPHA-METHYLTHIOFENTANYL
14 ALPHAPRODINE
15 ANILERIDINE
16 BENZETHIDINE
17 BENZYLMORPHINE
18 BETACETYLMETHADOL
19 BETA-HYDROXYFENTANYL
20 BETA-HYDROXY-3-METHYLFENTANYL
21 BETAMEPRODINE
22 BETAMETHADOL
23 BETAPRODINE
24 BEZITRAMIDE
25 BUTYRFENTANYL
26 CANNABIS
27 CANNABIS RESIN, EXTRACTS and TINCTURES
28 CARFENTANIL
29 CLONITAZENE
30 COCA LEAF
31 COCAINE
32 CODOXIME
33 CONCENTRATE OF POPPY STRAW
34 DESOMORPHINE
35 DEXTROMORAMIDE
36 DIAMPROMIDE
37 DIETHYLTHIAMBUTENE
38 DIFENOXIN
39 DIHYDROETORPHINE
40 DIHYDROMORPHINE
41 DIMENOXADOL
42 DIMEPHEPTANOL
43 DIMETHYLTHIAMBUTENE
44 DIOXAPHETYL BUTYRATE
45 DIPHENOXYLATE
46 DIPIPANONE
47 DROTEBANOL
48 ECGONINE
49 ETHYLMETHYLTHIAMBUTENE
50 ETONITAZENE
51 ETORPHINE
52 ETOXERIDINE
53 FENTANYL
54 4-FLUOROISOBUTYRFENTANYL (4-FIBF,pFiBFO)
55 FURANYLFENTANYL
56 FURETHIDINE
57 HEROIN
58 HYDROCODONE
59 HYDROMORPHINOL
60 HYDROMORPHONE
61 HYDROXYPETHIDINE
62 ISOMETHADONE
63 KETOBEMIDONE
64 LEVOMETHORPHAN
65 LEVOMORAMIDE
66 LEVOPHENACYLMORPHAN
67 LEVORPHANOL
68 METAZOCINE
69 METHADONE
70 METHADONE INTERMEDIATE
71 METHYLDESORPHINE
72 METHYLDIHYDROMORPHINE
73 3-METHYLFENTANYL
74 3-METHYLTHIOFENTANYL
75 METOPON
76 MORAMIDE INTERMEDIATE
77 MORPHERIDINE
78 MORPHINE
79 MORPHINE METHOBROMIDE
80 MORPHINE-N-OXIDE
81 MPPP
82 MT- 45
83 MYROPHINE
84 NICOMORPHINE
85 NORACYMETHADOL
86 NORLEVORPHANOL
87 NORMETHADONE
88 NORMORPHINE
89 NORPIPANONE
90 OCFENTANIL
91 OPIUM* (the coagulated juice of the opium poppy (plant species Papaver somniferum L.)
92 ORIPAVINE
93 OXYCODONE
94 OXYMORPHONE
95 PARA-FLUOROFENTANYL
96 PEPAP
97 PETHIDINE
98 PETHIDINE INTERMEDIATE A
99 PETHIDINE INTERMEDIATE B
100 PETHIDINE INTERMEDIATE C
101 PHENADOXONE
102 PHENAMPROMIDE
103 PHENAZOCINE
104 PHENOMORPHAN
105 PHENOPERIDINE
106 PIMINODINE
107 PIRITRAMIDE
108 PROHEPTAZINE
109 PROPERIDINE
110 RACEMETHORPHAN
111 RACEMORAMIDE
112 RACEMORPHAN
113 REMIFENTANIL
114 SUFENTANIL
115 TETRAHYDROFURANYLFENTANYL (THF-F)
116 THEBACON
117 THEBAINE (an alkaloid of opium; also found in Papaver bracteatum)
118 THIOFENTANYL
119 TILIDINE
120 TRIMEPERIDINE
121 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.

 

NOTE: The decisions during the 61st Session of the Commission on Narcotic Drugs (CND) shall become fully effective on the date of its receipt (June 11, 2018)

 

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