Compounding a Drug


Under the Naturopathy Act, 2007, a naturopath is authorized to perform the controlled act of “prescribing, dispensing, compounding or selling a drug designated in the regulations.”

The designated drugs are listed in table 5 of the General Regulation.  A naturopath may only compound a drug that is listed in table 5 and must do so in accordance with any limitations outlined in the table.  

When compounding a drug, the general requirements for performing a controlled act, as outlined on the About Controlled Acts page, do not apply.  Instead, Part II (Controlled Acts) of the General Regulation establishes the requirements that a naturopath must meet to compound a drug for a patient:
  • The naturopath can only compound a drug for their own patient.
  • The naturopath must have the knowledge, skill and judgment to compound drugs safely, competently and ethically.
  • Before compounding a drug, the naturopath must have considered the patient’s condition, the risks and benefits of compounding the drug and other relevant circumstances.
  • The naturopath must ensure that the compounding is performed in an aseptic preparation area, using aseptic techniques to minimize the risk of contamination.
  • The naturopath can only provide a compounded drug to their patient or their patient’s authorized representative.
  • Where a limitation, route of administration or dosage is indicated in table 5, the naturopath can only compound the drug in accordance with those conditions.
  • The naturopath must compound the drug for the purposes of providing a customized therapeutic solution for a particular patient.
  • The naturopath must advise the patient or their authorized representative that the drug may be compounded at a pharmacy.
  • The naturopath shall only compound a drug when a supply of a Health Canada- approved, commercially prepared product, which would meet the patient’s needs, is not reasonably available.
  • The naturopath must ensure that the drugs or other substances used in compounding have been obtained and stored in accordance with applicable laws.
  • The naturopath must ensure that the drugs or substances used on the compounding have not expired and will not expire before the date on which the patient is expected to take the last of the drug.
  • The naturopath must ensure that the container holding the drug (or, if there is not sufficient space, a paper attached to the container) contains the specified information.
  • The naturopath must retain a copy of the information specified to be on the container.

What is on a Container of a Compounded Drug?


The General Regulation requires that a naturopath include certain information on the container of a compounded drug, or on a piece of paper attached to the container (if there is not sufficient room on the container).  The information required includes:
  • Identification number, if applicable.
  • Naturopath’s name and title.
  • Name, address and telephone number of the location where the drug was compounded.
  • Identification of the drugs, substances and any other ingredients used in the compounding, their name, strength and, if available, their manufacturer.
  • Amount or percentage of each drug, substance and any other ingredients used to make the compounded product, and the quantity of the compounded product in the container.
  • Date the drug was compounded.
  • Expiry date of the compounded drug.
  • Name of the patient for whom the drug was compounded.
  • Directions for storage and use of the compounded drug, including its dose, frequency, route of administration and any special instructions.

Additional Education and Training


A naturopath may only compound a drug for a patient if they have met the Standard of Practice for Prescribing. It requires a member to successfully complete a College-approved course and an examination in Therapeutic Prescribing.  The College’s Naturopathic Doctor Registry includes information about whether a member has met this standard of practice.

What Can or Cannot be Compounded?


Substances on the Prescription Drug List or NAPRA Schedule 1 are drugs.  A naturopath can only compound a drug that appears on these lists if it also appears on table 5 of the Controlled Acts Regulation.  

Substances that do not appear on the Prescription Drug List, NAPRA Schedule 1 or table 5 are not drugs.  It is commonly accepted that substances that are not drugs may be used to prepare a compounded product.  For example, purified water may be used in creating a compound for oral or topical use.

Note:  When compounding a bag for IVIT, each substance used must appear on table 2.  For information, see the section on Administering a Substance by Injection.

Table 5


The following includes information in table 5 from the General Regulation.  Every precaution has been made to provide an accurate reproduction; in the case of a discrepancy, defer to the regulation.  Explanatory notes describe how the limitation should apply.  These notes are for information purposes and do not constitute advice from the College of Naturopaths of Ontario.

 Drug  Limitations, routes of administration, dosages  Explanatory note
Adenosine triphosphate  Only if compounded for intravenous injection.  This drug may only be compounded for administration by Intravenous Infusion Therapy.
Colchicine  Must not be compounded unless the drug is botanical colchicine compounded from the corm of colchicum autumnale.  This drug may only be compounded using the botanical version of colchicine that is compounded from the corm of colchicum autumnale. 
Dextrose Injection  Only if compounded when in concentrated solution for intravenous injection.  This drug may only be compounded in concentrated solution for administration by Intravenous Infusion Therapy. 
Digitalis Purpurea and its glycosides  Only if compounded in conjunction with monitoring of the patient’s serum levels by the member.  This drug can only be compounded in conjunction with monitoring the patient’s blood serum levels by the member. 
Estrogen (bioidentical)  Only if compounded in topical or suppository form.  This drug may only be compounded for use in a topical or suppository form. 
Folic Acid  Only if compounded in oral dosage containing more than 1.0 mg of folic acid per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1.0 mg of folic acid.  This is only a drug when compounded in a dosage of more than 1 mg per dose or more than 1 mg of daily dose.  A ND may compound at this level or higher where indicated and a prescription is provided.  Folic acid below 1 mg per dose or per daily dose is not a drug and does not require a prescription for compounding. 
L-Tryptophan  Only if compounded for patient’s use in oral dosage form at a concentration of more than 220 mg per dosage unit or per daily dose.   Recommended daily dose must not exceed 12g and must be provided in 3 to 4 equally divided doses. May also be compounded as a single ingredient intended for intravenous injection.  This is only a drug when compounded in oral dosage at a concentration of more than 220 mg per dosage unit or per daily dose.  The daily dose must not exceed 12g and must be provided in the dosed identified.  This drug may also be compounded as a single ingredient intended for IVIT. 
Levocarnitine and its Salts  Only if compounded for the treatment of primary or secondary levocarnitine deficiency.  This is only a drug when compounded for the treatment of primary or secondary levocarnitine deficiency in which case a prescription is required. If recommended for any other condition, it is not a drug and a prescription is not required. 
Pancreatin  Only if compounded in a dosage that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency.  This is a drug only when compounded in a form that provides more than 20,000 USP of lipase activity per dosage or at any dosage amount when compounded for the treatment of pancreatic exocrine insufficiency. Lower dosages for other conditions do not require a prescription for compounding. 
Pancrelipase  Only if compounded in a dosage that provides more than 20,000 USP units of lipase activity per dosage unit or for the treatment of pancreatic exocrine insufficiency.  This is a drug only when compounded at more than 20,000 USP of lipase per dose or when it is being compounded for treatment of pancreatic exocrine insufficiency. Lower dosages for other conditions do not require a prescription for compounding. 
Pilocarpine and its salts  Must not be compounded unless, 1. the drug is botanical pilocarpine, compounded from the leaves of pilocarpus microphyllus, 2. the member monitors his or her patient’s serum levels during treatment with the drug and, 3. the drug is never compounded to treat a patient with glaucoma.  This drug may only be compounded in its botanical form as identified and requires that the naturopath monitor the patient’s serum levels during treatment.  The drug cannot be compounded to treat a patient with glaucoma. 
Podophyllotoxin  Must not be compounded unless, 1. the drug is botanical podophyllotoxin, compounded from podophyllum peltatum and, 2. the drug is never compounded to treat a patient with rheumatoid arthritis.  This drug may only be compounded in its botanical form and cannot be compounded to treat a patient with rheumatoid arthritis. 
Progesterone (bioidentical)  Only if compounded in topical or suppository form.  This drug may only be compounded for use in a topical or suppository form. 
Rauwolfia  No limitation, etc., specified.   
Thyroid  No limitation, etc., specified.
 
Vitamin A
Only if compounded in oral dosage containing more than 10,000 International Units of Vitamin A per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 10,000 International Units of Vitamin A.  This is a drug only when compounded for oral use at more than 10,000 IU per dose or where the largest daily does would be more than 10,000 IU.  At lower levels for oral use, it is not a drug. 
Vitamin D Only if compounded in oral dosage containing more than 1,000 International Units of Vitamin D per dosage or, where the largest daily dosage would, if consumed by a patient, result in the daily intake by that patient of more than 1,000 International Units of Vitamin D.  This is a drug only when compounded for oral use at more than 1,000 IU per dose or where the largest daily does would be more than 1,000 IU.  At lower levels for oral use, it is not a drug. 
Vitamin K1 Only if compounded in oral dosage where the maximum daily dose is more than 0.120 mg.  This is a drug only when compounded for oral use at more that .120 mg per day.  At lower levels, it is not a drug. 
Vitamin K2  Only if compounded in oral dosage where the maximum daily dose is more than 0.120 mg.  This is a drug only when compounded for oral use at more that .120 mg per day.  At lower levels for oral use, it is not a drug. 
Yohimbine and its salts  Must not be compounded unless the drug is botanical yohimbine, compounded from the bark of pausinystalia yohimbine.  This is always a drug and always requires a prescription.  It may only be compounded in its botanical form as identified. 


For a copy of the General Regulation, see the Resources section of the College’s website.