Podcast
Questions and Answers
Which of the following is true about the Precursor Control Regulation?
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?
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?
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?
What do drugs listed under Schedule I of NAPRA Harmonized Schedules require for sale?
What is the significance of the 'Pr' symbol used for most Rx only drugs?
What is the significance of the 'Pr' symbol used for most Rx only drugs?
What is the purpose of the National Association of Pharmacy Regulatory Authorities (NAPRA)?
What is the purpose of the National Association of Pharmacy Regulatory Authorities (NAPRA)?
What does the Precursor Control Regulation classify certain chemicals as?
What does the Precursor Control Regulation classify certain chemicals as?
What is the requirement for keeping forms related to the Precursor Control Regulation?
What is the requirement for keeping forms related to the Precursor Control Regulation?
What is the former name of The Prescription Drug List?
What is the former name of The Prescription Drug List?
Which schedule is a list of radiopharmaceuticals and substances used in the preparation of radiopharmaceuticals?
Which schedule is a list of radiopharmaceuticals and substances used in the preparation of radiopharmaceuticals?
What is the criteria for purchasing FDA Schedule F drugs?
What is the criteria for purchasing FDA Schedule F drugs?
In Ontario, what is the legislated time frame for filling a prescription?
In Ontario, what is the legislated time frame for filling a prescription?
What is the warning label for drugs used as bronchodilators for people who experience difficulty in breathing?
What is the warning label for drugs used as bronchodilators for people who experience difficulty in breathing?
What is the list of biological products such as hormones, allergenic extracts, and immunizing agents?
What is the list of biological products such as hormones, allergenic extracts, and immunizing agents?
What is the current name of the list that was formerly called Schedule F, FDA Part I and Part II?
What is the current name of the list that was formerly called Schedule F, FDA Part I and Part II?
What is the requirement for Rx drugs in the Prescription Drug List?
What is the requirement for Rx drugs in the Prescription Drug List?
What is the criteria for extending a prescription for a patient that is neither a narcotic, controlled, nor targeted drug substance?
What is the criteria for extending a prescription for a patient that is neither a narcotic, controlled, nor targeted drug substance?
What happens to previously authorized unused refills in the event that a prescriber dies, moves away, or has his/her license revoked?
What happens to previously authorized unused refills in the event that a prescriber dies, moves away, or has his/her license revoked?
What is the requirement when increasing the amount of medication to be dispensed when there are authorized repeats?
What is the requirement when increasing the amount of medication to be dispensed when there are authorized repeats?
What is the requirement for the expiration date of unfilled prescriptions in Ontario?
What is the requirement for the expiration date of unfilled prescriptions in Ontario?
Which schedule of drugs in Canada requires professional intervention from the pharmacist and no public access?
Which schedule of drugs in Canada requires professional intervention from the pharmacist and no public access?
Where can Schedule III drugs be stored in a pharmacy according to Canadian regulations?
Where can Schedule III drugs be stored in a pharmacy according to Canadian regulations?
Which regulatory body controls the manufacture, packaging, and advertising standards of foods, drugs, cosmetics, and therapeutic devices in Canada?
Which regulatory body controls the manufacture, packaging, and advertising standards of foods, drugs, cosmetics, and therapeutic devices in Canada?
What is the main purpose of inspectors and analysts appointed by the FDA?
What is the main purpose of inspectors and analysts appointed by the FDA?
Which symbol is used to identify drugs in Schedule N?
Which symbol is used to identify drugs in Schedule N?
What must manufacturer's labels for drugs in Canada include?
What must manufacturer's labels for drugs in Canada include?
How long are prescription records required to be retained by federal legislation?
How long are prescription records required to be retained by federal legislation?
Which drugs in Canada can be sold from any retail outlet and require sufficient labeling for the safe and effective use of the drug?
Which drugs in Canada can be sold from any retail outlet and require sufficient labeling for the safe and effective use of the drug?
What is the schedule for Aspirin 81mg?
What is the schedule for Aspirin 81mg?
What does the FDA control in terms of drug manufacturing conditions?
What does the FDA control in terms of drug manufacturing conditions?
Who determines the expiration date of a drug?
Who determines the expiration date of a drug?
What is the role of the FDA in relation to deceptive advertising of drug products?
What is the role of the FDA in relation to deceptive advertising of drug products?
What does 'parenteral' administration refer to?
What does 'parenteral' administration refer to?
What does the FDA define to encompass various substances and their uses?
What does the FDA define to encompass various substances and their uses?
What is a 'prescription' according to the FDA labeling requirements?
What is a 'prescription' according to the FDA labeling requirements?
What does the FDA provide guidelines for in relation to drug products?
What does the FDA provide guidelines for in relation to drug products?
What is the role of a 'pharmacist' according to the FDA labeling requirements?
What is the role of a 'pharmacist' according to the FDA labeling requirements?
What is the main aim of the FDA in relation to drugs and other products?
What is the main aim of the FDA in relation to drugs and other products?
How is the expiration date of a drug expressed?
How is the expiration date of a drug expressed?
What guidelines are provided by the FDA according to the text?
What guidelines are provided by the FDA according to the text?
What is listed in Schedule A according to the FDA labeling requirements?
What is listed in Schedule A according to the FDA labeling requirements?
What is listed in Schedule B according to the FDA labeling requirements?
What is listed in Schedule B according to the FDA labeling requirements?
What is the purpose of the Excise Act, 2001 in Canada?
What is the purpose of the Excise Act, 2001 in Canada?
What is the primary difference between ethyl alcohol and rubbing alcohol according to the text?
What is the primary difference between ethyl alcohol and rubbing alcohol according to the text?
What is the purpose of denaturing alcohol in lab products?
What is the purpose of denaturing alcohol in lab products?
Under the Natural Health Products Regulation, 2004, what is required for the sale of natural health products in Canada?
Under the Natural Health Products Regulation, 2004, what is required for the sale of natural health products in Canada?
What is the main scope of natural health products (NHPs) as per the text?
What is the main scope of natural health products (NHPs) as per the text?
What is the role of the National Association of Pharmacy Regulatory Authorities (NAPRA) in Canada?
What is the role of the National Association of Pharmacy Regulatory Authorities (NAPRA) in Canada?
What is the significance of the 'Pr' symbol used for most Rx only drugs?
What is the significance of the 'Pr' symbol used for most Rx only drugs?
What is the requirement for keeping forms related to the Precursor Control Regulation in Canada?
What is the requirement for keeping forms related to the Precursor Control Regulation in Canada?
What does the Precursor Control Regulation classify certain chemicals as?
What does the Precursor Control Regulation classify certain chemicals as?
What is the former name of The Prescription Drug List?
What is the former name of The Prescription Drug List?
What is the role of the FDA in relation to deceptive advertising of drug products?
What is the role of the FDA in relation to deceptive advertising of drug products?
What regulatory body controls the manufacture, packaging, and advertising standards of foods, drugs, cosmetics, and therapeutic devices in Canada?
What regulatory body controls the manufacture, packaging, and advertising standards of foods, drugs, cosmetics, and therapeutic devices in Canada?
What is the requirement for obtaining signing privileges to order narcotics, controlled drugs, and targeted controlled substances in Ontario?
What is the requirement for obtaining signing privileges to order narcotics, controlled drugs, and targeted controlled substances in Ontario?
What is the purpose of the Narcotic and Controlled Drug Register?
What is the purpose of the Narcotic and Controlled Drug Register?
What is the source of supply for narcotics, controlled drugs, and targeted controlled substances in pharmacies?
What is the source of supply for narcotics, controlled drugs, and targeted controlled substances in pharmacies?
What information is required to be included in the purchase records for narcotics and controlled drugs in pharmacies?
What information is required to be included in the purchase records for narcotics and controlled drugs in pharmacies?
What is the purpose of the sales entry in the Narcotic and Controlled Drug Register or computer system records?
What is the purpose of the sales entry in the Narcotic and Controlled Drug Register or computer system records?
When are manual entries into the sales records of the Narcotic and Controlled Drug Register required?
When are manual entries into the sales records of the Narcotic and Controlled Drug Register required?
What is the requirement for obtaining emergency supplies of narcotics, controlled drugs, and targeted controlled substances from another pharmacy?
What is the requirement for obtaining emergency supplies of narcotics, controlled drugs, and targeted controlled substances from another pharmacy?
How often does a Narcotic Sales report for reportable narcotics and reportable controlled drugs need to be printed and maintained for audit purposes?
How often does a Narcotic Sales report for reportable narcotics and reportable controlled drugs need to be printed and maintained for audit purposes?
What is the filing requirement for narcotic and controlled drug prescriptions according to legislation?
What is the filing requirement for narcotic and controlled drug prescriptions according to legislation?
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?
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?
What is the requirement for recording the purchase of emergency supplies of narcotics, controlled drugs, and targeted controlled substances by a pharmacy?
What is the requirement for recording the purchase of emergency supplies of narcotics, controlled drugs, and targeted controlled substances by a pharmacy?
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?
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?
What is the required timeframe for keeping prescription orders as per the new legislation?
What is the required timeframe for keeping prescription orders as per the new legislation?
How often must physical inventory records of narcotics and controlled drugs be kept?
How often must physical inventory records of narcotics and controlled drugs be kept?
What is the recommended method for denaturing controlled substances?
What is the recommended method for denaturing controlled substances?
What is the requirement for the return of unopened, unsealed containers of targeted controlled substances?
What is the requirement for the return of unopened, unsealed containers of targeted controlled substances?
How many categories of narcotics are there according to the CDSA?
How many categories of narcotics are there according to the CDSA?
What can be done with expired narcotics and controlled drugs?
What can be done with expired narcotics and controlled drugs?
Which type of narcotics requires special guidelines and procedures for prescribing and dispensing due to its use for addiction treatment and pain relief?
Which type of narcotics requires special guidelines and procedures for prescribing and dispensing due to its use for addiction treatment and pain relief?
Where are reportable (straight) narcotics typically stored in pharmacies?
Where are reportable (straight) narcotics typically stored in pharmacies?
What symbol must be present on the label of narcotics under Schedule I of the CDSA?
What symbol must be present on the label of narcotics under Schedule I of the CDSA?
What are the dispensing requirements for reportable narcotics?
What are the dispensing requirements for reportable narcotics?
How are reportable narcotics allowed to be purchased?
How are reportable narcotics allowed to be purchased?
What is the requirement for repeats of reportable narcotics?
What is the requirement for repeats of reportable narcotics?
Which type of prescription is accepted for narcotic preparations, with the physician's signature verified and faxes verified as per policy?
Which type of prescription is accepted for narcotic preparations, with the physician's signature verified and faxes verified as per policy?
What is the requirement for sales records of verbal prescription narcotics?
What is the requirement for sales records of verbal prescription narcotics?
For which type of narcotics are repeat purchases not permitted?
For which type of narcotics are repeat purchases not permitted?
What is the requirement for purchasing reportable controlled drugs?
What is the requirement for purchasing reportable controlled drugs?
What is the requirement for maintaining prescriptions for controlled drugs?
What is the requirement for maintaining prescriptions for controlled drugs?
What is the restriction for transfers of authorized repeats for controlled drugs in Part II?
What is the restriction for transfers of authorized repeats for controlled drugs in Part II?
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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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