Pharmaceutical Regulations

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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?

The dosage instructions and potential side effects

The individual symbol, number, company name, words, letters, marking or National Drug Code (N.D.C.) number identifying the manufacturer or distributor of the drug (correct)

The name and address of the prescribing doctor

The drug's manufacturing date and expiration date

What is the purpose of the National Drug Code (N.D.C.) number on a prescription drug?

To track the drug's manufacturing date and expiration date

To provide dosage instructions and potential side effects

To identify the manufacturer or distributor of the drug

To identify the specific drug or combination of drugs (correct)

What information must be included on the label of a prescription drug product if the distributor does not also manufacture the product?

The manufacturer's name and address only

The distributor's name and address only

The names and places of business of both the manufacturer and distributor (correct)

The drug's manufacturing date and expiration date

Which of the following is an exception to the requirement for marking or imprinting prescription drugs?

Drugs authorized by the Federal Food, Drug and Cosmetic Act Signup and view all the answers

What is the purpose of marking or imprinting prescription drugs in New York State?

To identify the drug's manufacturer or distributor Signup and view all the answers

Which of the following is a requirement for prescription drugs contained in a bottle, vial, carton, or other container?

The container must have clearly and permanently marked or imprinted information identifying the manufacturer or distributor and the drug Signup and view all the answers

What is required to be marked or imprinted on each tablet or capsule of a prescription drug in New York State?

The individual symbol, number, company name, words, letters, marking or National Drug Code (N.D.C.) number identifying the manufacturer or distributor of the drug, and an N.D.C. number, symbol, number, letters, words or marking identifying the drug Signup and view all the answers

Which agency authorizes exceptions to the marking and imprinting requirements for prescription drugs?

The Federal Food and Drug Administration (FDA) Signup and view all the answers

What is the purpose of a plan submitted by a manufacturer or distributor to the commissioner of health?

To provide a timeline for complying with marking and labeling requirements Signup and view all the answers

Who may exempt a particular tablet or capsule from the requirements of this section?

The commissioner of health Signup and view all the answers

What is the minimum fine for a first-time offense of violating the provisions of this section?

$2,500 Signup and view all the answers

What is the purpose of the printed material that manufacturers and distributors must provide to certain entities?

To identify each imprint used by the manufacturer or distributor Signup and view all the answers

Who is responsible for seizing prescription drug products manufactured or prepared in violation of this section?

The state board of pharmacy or a law enforcement officer Signup and view all the answers

What is the term for the entire supply of the finished dosage form of the drug?

Drug product Signup and view all the answers

Who is exempt from the provisions of this section?

Pharmacists who prepare or manufacture tablets or capsules for retail sale Signup and view all the answers

What is the purpose of the Physician's Desk Reference?

To comply with the provisions of this section Signup and view all the answers

What happens to a prescription drug product that is prepared or manufactured in violation of this section?

It is seized by the state board of pharmacy or a law enforcement officer Signup and view all the answers

Who is considered a distributor under this section?

A person, firm, corporation, or entity that distributes a prescription drug product for resale under their own label Signup and view all the answers

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.