Canadian Drug Regulations and Labeling Quiz

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Questions and Answers

Which of the following is true about the Precursor Control Regulation?

It applies to packages/bottles purchased from wholesalers containing over 3 grams pseudoephedrine or 400mg ephedrine. (correct)

It came into effect on July 7th, 2003.

It only applies to retail pharmacy chains.

It requires pharmacists to submit annual reports to Health Canada.

What is the purpose of the end-use declaration required by the Precursor Control Regulation?

To notify Health Canada about any adverse effects of the regulated chemicals.

To ensure accountability and track the use of specified chemicals. (correct)

To restrict the sale of all chemical products to pharmacies.

To provide evidence of pharmacist qualifications.

What is the role of NAPRA in relation to the national drug schedule model?

NAPRA enforces the national drug schedule model in Quebec.

NAPRA only represents the interests of pharmacists, not regulatory authorities.

NAPRA was instrumental in developing the national drug schedule model adopted across Canada. (correct)

NAPRA has no involvement in drug scheduling decisions.

What do drugs listed under Schedule I of NAPRA Harmonized Schedules require for sale?

They require a prescription for sale and are provided by a pharmacist following professional intervention of a physician or other prescribers. Signup and view all the answers

What is the significance of the 'Pr' symbol used for most Rx only drugs?

It indicates that the drug requires a prescription for sale. Signup and view all the answers

What is the purpose of the National Association of Pharmacy Regulatory Authorities (NAPRA)?

To develop and enforce national standards for pharmacy regulation. Signup and view all the answers

What does the Precursor Control Regulation classify certain chemicals as?

Class A precursors due to their potential use in illegal substance production. Signup and view all the answers

What is the requirement for keeping forms related to the Precursor Control Regulation?

Forms must be kept on file at the wholesaler and renewed annually. Signup and view all the answers

What is the former name of The Prescription Drug List?

Schedule F, FDA Part I and Part II Signup and view all the answers

Which schedule is a list of radiopharmaceuticals and substances used in the preparation of radiopharmaceuticals?

Schedule C Signup and view all the answers

What is the criteria for purchasing FDA Schedule F drugs?

Purchases may be verbal, electronic, or by written or faxed purchase order from a licensed dealer Signup and view all the answers

In Ontario, what is the legislated time frame for filling a prescription?

There is no legislated time frame Signup and view all the answers

What is the warning label for drugs used as bronchodilators for people who experience difficulty in breathing?

Warning: Do not exceed the dose prescribed by your physician Signup and view all the answers

What is the list of biological products such as hormones, allergenic extracts, and immunizing agents?

Schedule D Signup and view all the answers

What is the current name of the list that was formerly called Schedule F, FDA Part I and Part II?

The Prescription Drug List Signup and view all the answers

What is the requirement for Rx drugs in the Prescription Drug List?

All Rx drugs require a prescription for sale Signup and view all the answers

What is the criteria for extending a prescription for a patient that is neither a narcotic, controlled, nor targeted drug substance?

The pharmacist must notify the physician by fax or phone Signup and view all the answers

What happens to previously authorized unused refills in the event that a prescriber dies, moves away, or has his/her license revoked?

They become invalid Signup and view all the answers

What is the requirement when increasing the amount of medication to be dispensed when there are authorized repeats?

Obtaining the approval of the prescriber Signup and view all the answers

What is the requirement for the expiration date of unfilled prescriptions in Ontario?

There is no legislated time frame Signup and view all the answers

Which schedule of drugs in Canada requires professional intervention from the pharmacist and no public access?

Schedule II Signup and view all the answers

Where can Schedule III drugs be stored in a pharmacy according to Canadian regulations?

Self-selection area under pharmacist supervision Signup and view all the answers

Which regulatory body controls the manufacture, packaging, and advertising standards of foods, drugs, cosmetics, and therapeutic devices in Canada?

The Food and Drugs Act (FDA) Signup and view all the answers

What is the main purpose of inspectors and analysts appointed by the FDA?

To examine foods and drugs for undisclosed substances Signup and view all the answers

Which symbol is used to identify drugs in Schedule N?

N Signup and view all the answers

What must manufacturer's labels for drugs in Canada include?

Proper and common names of any drugs contained in the product Signup and view all the answers

How long are prescription records required to be retained by federal legislation?

10 years Signup and view all the answers

Which drugs in Canada can be sold from any retail outlet and require sufficient labeling for the safe and effective use of the drug?

Schedule IV Signup and view all the answers

What is the schedule for Aspirin 81mg?

Schedule III Signup and view all the answers

What does the FDA control in terms of drug manufacturing conditions?

Safety and sanitary conditions of manufacturing plants Signup and view all the answers

Who determines the expiration date of a drug?

Manufacturer Signup and view all the answers

What is the role of the FDA in relation to deceptive advertising of drug products?

Prohibits deceptive advertising of drug products Signup and view all the answers

What does 'parenteral' administration refer to?

Injection into the skin or mucous membrane Signup and view all the answers

What does the FDA define to encompass various substances and their uses?

Food, drug, cosmetic, and therapeutic device Signup and view all the answers

What is a 'prescription' according to the FDA labeling requirements?

An order by a practitioner for a stated amount of drug Signup and view all the answers

What does the FDA provide guidelines for in relation to drug products?

Coloring and flavoring agents Signup and view all the answers

What is the role of a 'pharmacist' according to the FDA labeling requirements?

Operating a pharmacy and dispensary Signup and view all the answers

What is the main aim of the FDA in relation to drugs and other products?

To ensure the safety and appropriate use of drugs and other products Signup and view all the answers

How is the expiration date of a drug expressed?

Month/year Signup and view all the answers

What guidelines are provided by the FDA according to the text?

Child-resistant packaging guidelines and safety testing standards Signup and view all the answers

What is listed in Schedule A according to the FDA labeling requirements?

Diseases, disorders, or abnormal physical states for which drugs can be advertised or labeled for treatment, prevention, or cure Signup and view all the answers

What is listed in Schedule B according to the FDA labeling requirements?

Established sources on drugs accepted as a set of standard purity Signup and view all the answers

What is the purpose of the Excise Act, 2001 in Canada?

To regulate the manufacture, purchase, and sale of alcohol and alcohol products Signup and view all the answers

What is the primary difference between ethyl alcohol and rubbing alcohol according to the text?

Ethyl alcohol is for internal use, while rubbing alcohol is for external use Signup and view all the answers

What is the purpose of denaturing alcohol in lab products?

To prevent human consumption Signup and view all the answers

Under the Natural Health Products Regulation, 2004, what is required for the sale of natural health products in Canada?

Product and site licences Signup and view all the answers

What is the main scope of natural health products (NHPs) as per the text?

Maintaining or promoting health, treating or preventing diseases or conditions in humans Signup and view all the answers

What is the role of the National Association of Pharmacy Regulatory Authorities (NAPRA) in Canada?

Developing and maintaining the national drug schedule model Signup and view all the answers

What is the significance of the 'Pr' symbol used for most Rx only drugs?

It signifies that the drug is a prescription medication Signup and view all the answers

What is the requirement for keeping forms related to the Precursor Control Regulation in Canada?

Record-keeping for the use of precursor chemicals Signup and view all the answers

What does the Precursor Control Regulation classify certain chemicals as?

Precursor chemicals Signup and view all the answers

What is the former name of The Prescription Drug List?

Schedule F Signup and view all the answers

What is the role of the FDA in relation to deceptive advertising of drug products?

Enforcing regulations to prevent deceptive advertising Signup and view all the answers

What regulatory body controls the manufacture, packaging, and advertising standards of foods, drugs, cosmetics, and therapeutic devices in Canada?

Health Canada Signup and view all the answers

What is the requirement for obtaining signing privileges to order narcotics, controlled drugs, and targeted controlled substances in Ontario?

A pharmacist must obtain signing privileges from the Ontario College of Pharmacists by requesting authorization in writing Signup and view all the answers

What is the purpose of the Narcotic and Controlled Drug Register?

To record all purchases and bulk compounding of narcotics and controlled drugs Signup and view all the answers

What is the source of supply for narcotics, controlled drugs, and targeted controlled substances in pharmacies?

Wholesale/distributors such as McKesson Canada and direct from the manufacturer Signup and view all the answers

What information is required to be included in the purchase records for narcotics and controlled drugs in pharmacies?

Date, name of the drug, quantity, size, and name/address of the supplier Signup and view all the answers

What is the purpose of the sales entry in the Narcotic and Controlled Drug Register or computer system records?

To record sales of reportable narcotics and reportable controlled drugs when dispensed Signup and view all the answers

When are manual entries into the sales records of the Narcotic and Controlled Drug Register required?

For emergency sales of controlled drugs from another pharmacy and sales to physicians for their office use Signup and view all the answers

What is the requirement for obtaining emergency supplies of narcotics, controlled drugs, and targeted controlled substances from another pharmacy?

A prescription for the drug is written with the pharmacy name as purchaser, signed by a staff pharmacist Signup and view all the answers

How often does a Narcotic Sales report for reportable narcotics and reportable controlled drugs need to be printed and maintained for audit purposes?

Bi-weekly Signup and view all the answers

What is the filing requirement for narcotic and controlled drug prescriptions according to legislation?

Narcotic and controlled drug prescriptions must be filed separately from non-narcotic and non-controlled drug prescriptions Signup and view all the answers

What is the requirement when 2 prescriptions have been written on the same prescription form, one for a narcotic or a controlled drug, and the other neither a narcotic nor controlled drug?

Both prescriptions must be cross-referenced Signup and view all the answers

What is the requirement for recording the purchase of emergency supplies of narcotics, controlled drugs, and targeted controlled substances by a pharmacy?

The purchase must be recorded in the appropriate section of the Narcotic and Controlled Drug Register Signup and view all the answers

What is the requirement for the sale of verbal narcotic preparations and controlled drug preparations to a practitioner for office use, his/her own use, or for any member of his/her family when the practitioner has issued the prescription?

The sale must be entered in the pharmacy's sales records manually or via the computer Signup and view all the answers

What is the required timeframe for keeping prescription orders as per the new legislation?

10 years from the last dispensing date Signup and view all the answers

How often must physical inventory records of narcotics and controlled drugs be kept?

Twice annually Signup and view all the answers

What is the recommended method for denaturing controlled substances?

Adding water or soap solution Signup and view all the answers

What is the requirement for the return of unopened, unsealed containers of targeted controlled substances?

Authorization required in all cases Signup and view all the answers

How many categories of narcotics are there according to the CDSA?

3 Signup and view all the answers

What can be done with expired narcotics and controlled drugs?

They can be returned to the manufacturer or wholesaler with prior permission Signup and view all the answers

Which type of narcotics requires special guidelines and procedures for prescribing and dispensing due to its use for addiction treatment and pain relief?

Reportable narcotics Signup and view all the answers

Where are reportable (straight) narcotics typically stored in pharmacies?

In a locked cabinet Signup and view all the answers

What symbol must be present on the label of narcotics under Schedule I of the CDSA?

N within a circle Signup and view all the answers

What are the dispensing requirements for reportable narcotics?

Patient information, drug details, directions for use, and prescriber details Signup and view all the answers

How are reportable narcotics allowed to be purchased?

Through written or electronic means, with specific requirements for order submission and recording Signup and view all the answers

What is the requirement for repeats of reportable narcotics?

Repeats are not permitted; a new prescription is required for each fill Signup and view all the answers

Which type of prescription is accepted for narcotic preparations, with the physician's signature verified and faxes verified as per policy?

Verbal, written, and faxed prescriptions Signup and view all the answers

What is the requirement for sales records of verbal prescription narcotics?

No entry required; the filed prescription serves as the sales record Signup and view all the answers

For which type of narcotics are repeat purchases not permitted?

Verbal prescription narcotics Signup and view all the answers

What is the requirement for purchasing reportable controlled drugs?

Written or electronic means, with a record of all purchases required Signup and view all the answers

What is the requirement for maintaining prescriptions for controlled drugs?

Maintained in a dedicated file, with repeat authorizations and restrictions for written and verbal prescriptions Signup and view all the answers

What is the restriction for transfers of authorized repeats for controlled drugs in Part II?

Not permitted Signup and view all the answers

Study Notes

Food and Drugs Act, 1990 (FDA) Labeling Requirements

The manufacturer's label should include the name and address of the manufacturer, a list of medicinal ingredients, lot #, directions for use, quantity, and expiration date of the drug.
The label should also include the Drug Identification Number (DIN) or "GP" for proprietary medicines, potency, and cautionary or warning statements if required.
Symbols such as "Pr", "C", or "N" are used to identify drugs in Schedule F, G, or N respectively.
Retention of prescription records for 10 years is required by federal legislation, while the Canada Revenue Agency requires sales transaction records to be kept for 7 years.
Aspirin 81mg is scheduled III, while 325mg and 500mg per dosage unit aspirin products are unscheduled.
Definitions of terms like "common name," "internal use," and "official drug" are provided by the FDA.
"Parenteral" administration refers to injecting a drug into the skin or mucous membrane, and a "practitioner" is a licensed medical professional.
A "prescription" is an order by a practitioner for a stated amount of drug, and a "pharmacist" is a licensed professional who operates a pharmacy and dispensary.
The expiration date of a drug is determined by its labeled potency, purity, and physical characteristics, and is expressed as month/year.
Child-resistant packaging guidelines and safety testing standards are provided by the FDA.
Schedule A lists diseases, disorders, or abnormal physical states for which drugs can be advertised or labeled for treatment, prevention, or cure.
Schedule B lists established sources on drugs accepted as a set of standard purity, such as the British Pharmacopeia (PH.F).

Canadian Drug Regulations and Health Product Laws

Prescription Drug List Warning labels should be applied to specific drugs, including Epinephrine, Formoterol, Ipratropium, Salmeterol, and others.
FDA has various drug schedules like Schedule G, H, I, J, and N, each with specific restrictions and guidelines.
Drug scheduling recommendations follow a "cascading principle" where drugs are assessed against factors for different schedules.
The Excise Act, 2001 is a federal law controlling the manufacture, purchase, and sale of alcohol and alcohol products in Canada.
The Act outlines record-keeping procedures and reporting requirements for the use of ethyl alcohol, including perpetual inventory records.
Ethyl alcohol can only be purchased by pharmacists for internal use and is closely monitored, while rubbing alcohol is used externally.
The Act also regulates the manufacture and sale of specially denatured alcohol and outlines guidelines for other forms of alcohol.
Methyl alcohol preparations like methanol and Sterno may be sold in pharmacies, but ingesting methanol can be extremely poisonous.
The alcohol used in lab products is denatured with methanol and must be disposed of within the lab period.
Health Canada regulates natural health products (NHPs) under the Natural Health Products Regulation, 2004, requiring product and site licences for sale.
The regulation includes schedules of natural health product substances and botanicals with a history of safe use in specific populations.
NHPs encompass products for maintaining or promoting health, treating or preventing diseases or conditions in humans.

Controlled Substances Regulations Summary

Verbal, written, and faxed prescriptions are accepted for narcotic preparations, with the physician's signature verified and faxes verified as per policy.
Sales records for verbal prescription narcotics do not require entry; the filed prescription serves as the sales record, and repeats are not permitted.
Part-fills of narcotic prescriptions are allowed, with the total and part-fill quantities indicated, and transfers are not permitted.
OTC narcotics, such as those containing codeine phosphate, are exempted from prescription requirements but must be stored in the dispensary, with sales involving pharmacist involvement.
Examples of OTC narcotics include Tylenol #1, AC&C 8mg, Mersyndol, and Robaxacet-8, and they may be purchased by written, verbal, or electronic means.
Reportable controlled drugs, containing substances listed under Schedule III, Part I, CDSA, may be purchased by written or electronic means, with a record of all purchases required.
Prescription requirements for reportable controlled drugs include acceptance of written, verbal, or faxed prescriptions, with the physician's signature verified and sales records required.
All prescriptions for controlled drugs must be maintained in a dedicated file, with repeat authorizations and restrictions for written and verbal prescriptions.
Part-fills are allowed for certain categories of controlled drugs, but transfers of authorized repeats are not permitted.
Purchasing of reportable controlled drugs requires the identification number of a pharmacist with signing authority for electronic orders.
A record of all purchases for controlled drugs is required in the Narcotic and Controlled Drug Register, and a copy of all reportable drugs may be obtained using the computer system's report function.
For controlled drugs in Part II, transfers of authorized repeats, including part-fills and logged prescriptions, are not permitted.

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Description

Test your knowledge of Canadian drug regulations and labeling requirements with this quiz. Explore the Food and Drugs Act (FDA) requirements for drug labeling, prescription drug list warnings, drug scheduling, and regulations for alcohol and natural health products.