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Questions and Answers
What must be clearly marked or imprinted on each tablet or capsule of a prescription drug in New York State?
What must be clearly marked or imprinted on each tablet or capsule of a prescription drug in New York State?
What is the purpose of the National Drug Code (N.D.C.) number on a prescription drug?
What is the purpose of the National Drug Code (N.D.C.) number on a prescription drug?
What information must be included on the label of a prescription drug product if the distributor does not also manufacture the product?
What information must be included on the label of a prescription drug product if the distributor does not also manufacture the product?
Which of the following is an exception to the requirement for marking or imprinting prescription drugs?
Which of the following is an exception to the requirement for marking or imprinting prescription drugs?
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What is the purpose of marking or imprinting prescription drugs in New York State?
What is the purpose of marking or imprinting prescription drugs in New York State?
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Which of the following is a requirement for prescription drugs contained in a bottle, vial, carton, or other container?
Which of the following is a requirement for prescription drugs contained in a bottle, vial, carton, or other container?
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What is required to be marked or imprinted on each tablet or capsule of a prescription drug in New York State?
What is required to be marked or imprinted on each tablet or capsule of a prescription drug in New York State?
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Which agency authorizes exceptions to the marking and imprinting requirements for prescription drugs?
Which agency authorizes exceptions to the marking and imprinting requirements for prescription drugs?
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What is the purpose of a plan submitted by a manufacturer or distributor to the commissioner of health?
What is the purpose of a plan submitted by a manufacturer or distributor to the commissioner of health?
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Who may exempt a particular tablet or capsule from the requirements of this section?
Who may exempt a particular tablet or capsule from the requirements of this section?
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What is the minimum fine for a first-time offense of violating the provisions of this section?
What is the minimum fine for a first-time offense of violating the provisions of this section?
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What is the purpose of the printed material that manufacturers and distributors must provide to certain entities?
What is the purpose of the printed material that manufacturers and distributors must provide to certain entities?
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Who is responsible for seizing prescription drug products manufactured or prepared in violation of this section?
Who is responsible for seizing prescription drug products manufactured or prepared in violation of this section?
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What is the term for the entire supply of the finished dosage form of the drug?
What is the term for the entire supply of the finished dosage form of the drug?
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Who is exempt from the provisions of this section?
Who is exempt from the provisions of this section?
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What is the purpose of the Physician's Desk Reference?
What is the purpose of the Physician's Desk Reference?
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What happens to a prescription drug product that is prepared or manufactured in violation of this section?
What happens to a prescription drug product that is prepared or manufactured in violation of this section?
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Who is considered a distributor under this section?
Who is considered a distributor under this section?
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Study Notes
Prescription Drug Labeling Requirements
- Drugs requiring a prescription must be labeled with:
- An individual symbol, number, company name, words, letters, marking, or National Drug Code (N.D.C.) number identifying the manufacturer or distributor
- An N.D.C. number, symbol, number, letters, words, or marking identifying the drug or combination of drugs
Container Labeling Requirements
- Containers or packages of prescription drugs must be labeled with:
- An individual symbol, N.D.C. number, company name, number, letters, words, or marking identifying the manufacturer or distributor
- An N.D.C. number, symbol, number, letters, words, or marking identifying the drug or combination of drugs
- The names and places of business of both the manufacturer and distributor, if they are different entities
Manufacturer and Distributor Compliance
- Manufacturers and distributors must submit a proposed plan to the commissioner of health to comply with labeling requirements
- The plan must include:
- A timetable for compliance
- Reasons for the proposed compliance date
- Other relevant information
- The commissioner of health may approve, amend, or promulgate a plan for the manufacturer or distributor
Information Availability
- Manufacturers and distributors must publish and make available to requesters a list of imprints used
- Updated materials must be provided as changes occur, upon annual request
- This provision is deemed complied with if the drug product is included in the Physician's Desk Reference
Penalties and Exemptions
- Violations of this section are punishable by a fine of $2,500 to $10,000
- Drugs prepared or manufactured in violation of this section are considered contraband and subject to seizure
- Exemptions may be granted for tablets or capsules containing controlled substances, prepared by licensed pharmacists, or deemed unfeasible to label due to size or texture.
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Description
This quiz covers the laws and regulations related to manufacturing and distribution of prescription drugs in tablet or capsule form.
