REGULATORY REQUIREMENTS under the Controlled Drugs and Substances Act (CDSA)
PRECURSOR CONTROL REGULATIONS (PCR) Domestic
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CLASS A PRECURSORS
- Acetic anhydride
- N-Acetylanthranilic acid and its salts
- Anthranilic acid and its salts
- 1,4-Butanediol1
- Ephedra
- Ephedrine, its salts and any plant containing ephedrine or any of its salts
- Ergometrine and its salts
- Ergotamine and its salts
- Gamma-Butyrolactone1
- Hydriodic acid1
- Hypophosphorous acid, its salts and derivatives1
- Isosafrole
- Lysergic acid and its salts
- 3,4-Methylenedioxyphenyl-2-propanone
- Norephedrine (Phenylpropanolamine) and its salts
- 1-Phenyl-2-propanone
Phenylacetic acid and its salts
- Piperidine and its salts
- Piperonal
Potassium permanganate
- Pseudoephedrine and its salts
- Red Phosphorus1
- Safrole and any essential oil containing 4% or more safrole
- White Phosphrus1
1 These six new substances come into force on January 31st, 2006
CLASS B PRECURSORS
- Acetone
- Ethyl ether
- Hydrochloric acid
- Methyl ethyl ketone
- Sulphuric acid
- Toluene
CLASS A PRECURSORS
COMING INTO FORCE DATES
January 9, 2003
- a licence is required to import, export, produce, and package
- a permit is required to import, export and transit/transhipment
- only a licensed dealer may apply for an import or export permit
July 7, 2003
- a licence is required to sell/provide
LICENCE REQUIREMENTS
- a licence is required to import, export, produce, package or sell/provide
- an end use declaration is required when selling Class A precursors to non-licensed dealers in quantities or package sizes greater than the threshold in the schedule to the Regulations¹
- it may take up to 150 days for processing applications, due to the criminal record check requirement
EXEMPTION FOR SELL/ PROVIDE (SECTION 5)
The individual or business will be exempted for sell/provide if all of the following criteria are met:
- sells/provides Class A precursors on a retail basis (selling goods for the purpose of end-use and not re-sale);
- sells/provides a selection of goods that is not limited to chemicals or chemicals equipment used in the chemical industry for the production, processing or storage of chemicals; and
To sells/provide:
- a Class A precursor in a quantity or package size, per transaction, that does not exceed the threshold in the schedule (see below) to the Regulations.
- a preparation or mixture containing a Class A precursor in a quantity or package size, per transaction, that does not exceed the threshold in the schedule (see below) to the Regulations
NOTE: If the individual or business sells precursors over the quantity or package size specified in the Schedule, they will NOT meet the requirements for this exemption.
INDIVIDUAL EXEMPTIONS
Section 48, provides a process to exempt preparations and mixtures where the Class A precursor cannot be readily extracted or the product itself cannot be used in the production of a controlled substance
GENERAL EXEMPTIONS
The following are exempted from the application of PCR:
Schedule F Drugs
- domestic distribution (sell/provide) of drugs in dosage form that contain a Class A precursor listed in Schedule F to the Food and Drug Regulations.
Schedules I, III, or IV
- domestic distribution (sell/provide) of drugs in dosage form that contain a Class A precursor and one or more controlled substances listed in Schedule I, III, or IV to the Controlled Drugs and Substances Act .
Fragrances or flavourings
- containing a total concentration no more than 20% by weight or volume in the case of a solid or liquid of anthranilic acid, N-anthranilic acid, gamma-butyrolactone, phenylacetic acid, piperonal or piperidine, AND is intended to be used in a food, drug, cosmetic or household product.
Formulated silicone products
- containing 1% or less of acetic anhydride that is a sealant, adhesive, or coating.
Gamma-butyrolactone (GLB) and 1,4-butanediol (BDO)
- contains GLB or BDO in a total concentration equal or less than 20% by weight or volume in the case of a solid or liquid and is intended to be used for specific industrial uses including cleaning or etching preparations for electronic devices, components and parts; biofermentation for polyester production; and as ingredients in pesticides, melamine coatings, automotive coatings, and resin systems for manufacturing polyurethane.
CLASS B PRECURSORS
COMING INTO FORCE DATE
January 1, 2004 - a registration is required to import, export and produce for sale
- a permit is required to export certain Class B precursors to specific destinations
- no permit is required to import Class B precursors
- only a registered dealer may apply for an export permit
REGISTRATION
- it may take up to 75 days for processing applications, due to the criminal record check requirement
- there are NO registration requirements for sell/provide
INDIVIDUAL EXEMPTIONS
Section 76 provides a process to exempt preparations and mixtures where the Class B precursors can not be readily extracted or the products itself cannot be used in the production of a controlled substance
GENERAL EXEMPTIONS
Preparations or mixtures containing a total concentration of Class B precursors that does not exceed 30% by weight or volume, in the case of a solid or liquid
SCHEDULE
| Class A Precursors |
C l |
Maximum Quantity |
| Acetic anhydride |
|
1000 kg |
| N-Acetylanthranilic acid |
|
1 kg |
| Anthranilic acid |
|
1 kg |
| 1,4-Butanediol |
|
0 |
| Ephedra |
|
20 g/pkg |
| Ephedrine |
|
0.4 g/pkg |
| Ergometrine |
|
0 |
| Ergotamine |
|
0 |
| Gamma-butyrolactone |
|
0 |
| Hydriodic acid |
|
0 |
| Hypophosphorous acid |
|
0 |
| Isosafrole |
|
0.5 kg |
| Lysergic acid |
3 |
0 |
| 3,4-Methylenedioxyphenyl-2-propanone |
N |
0 |
| Norephedrine (Phenylpropanolamine) |
1 |
0 |
| 1-Phenyl-2-propanone |
P |
0 |
| Phenylacetic acid |
P |
1 kg |
| Piperidine |
P |
0.5 kg |
| Piperonal |
P |
0.5 kg |
| Potassium permanganate |
P |
50 kg |
| Pseudoephedrine |
R |
3 g/pkg |
| Red Phosphorus |
S |
0 |
| Safrole |
W |
0.25kg |
| White Phosphorus |
|
0 |
INFORMATION RESOURCES
The
Precursor Control Regulations can be obtained from the Canada Gazette Web site:
http://canadagazette.gc.ca/partII/tempPdf/g2-13621.pdf
(under bookmarks SOR/DORS/2002-359 and 361)
The
Precursor Conrtol Regulations new amendments can be obtained from the Canada Gazette Web site:
http://canadagazette.gc.ca/partII/2005/20051214/pdf/g2-13925.pdf
(pages 2743 to 2786)
A series of guidance documents written as a companion to the Precursor Control Regulations to provide guidance on meeting the regulatory requirements under these Regulations, as well as application forms can be obtained from the Health Canada Web site:
http://www.healthcanada.gc.ca/precursors
or by contacting the Office of Controlled Substances, Drug Strategy and Controlled Substances Programme, Health Canada, at:
613-946-1142