Misbranding a Controlled Substance in New Jersey

The law in New Jersey coincides with the Federal Food, Drug & Cosmetic Act that prohibits selling, distributing, or manufacturing articles that are “adulterated or misbranded.” This applies to products including food, drugs, cosmetics, and other devices. Products may be considered as adulterated or misbranded when the details that list the ingredients are somehow incorrect or misleading. Essentially, labeling or packaging contains a false description of the product's contents. Here, we look specifically at misbranding of controlled substances.

Misbranded Drug

New Jersey considers a drug to be misbranded when the description of ingredients is inaccurate. Misbranding also may occur when the labeling of the product does not have the name and address information for the “manufacturer, packer, or distributor.” A controlled substance is one that is deemed as having the potential to be abused. These are classified in Schedules I through V.

 

Examples

Description

Schedule I

LSD, Peyote, Mescaline, Heroin

Very likely to be abused--no medical purposes

Schedule II

Fentanyl, Methadone, Opium

High potential to be abused--some medical purposes

Schedule III

Amphetamine, Methamphetamine

Some potential for abuse—some medical purposes

Schedule IV

Phenobarbital, Valium

Lower potential for abuse—many medical purposes

Schedule V

Lyrica, Various Cough Suppressants

Low potential for abuse--many medical purposes

Pharmacy Compliance

The New Jersey State Board of Pharmacy assigns some specific responsibilities to the pharmacist-in-charge (PIC). The PIC is responsible for the management of the pharmacy's inventory and staff. One key responsibility is properly labeling all prescription products. The pharmacy must have a written policy in place that is subject to review by the Board when requested and it must be formally reviewed every two years. All pharmacy staff must be properly licensed and adhere to strict recordkeeping requirements. The PIC is ultimately responsible for any drugs that are “misbranded, deteriorated, adulterated, improperly stored, or outdated.” This also applies to any drugs that are designated as samples.

Wholesaler Regulations

Those operating in wholesale distribution also have a specific set of regulations to adhere to.

  • The setting must be an appropriate size to allow for regular cleaning, maintenance, and operations.
  • The setting must have sufficient lighting, be properly ventilated, have the temperature and humidity controlled, and have security in place.
  • A designated quarantine area must be maintained that will store any products that are expired, misbranded, adulterated, or otherwise unsuitable for use.

These facilities must properly examine all materials when drugs are received. The exterior of all containers that have prescription products must be closely inspected for any evidence of damage. This is the first means of preventing any products that are unfit for distribution from being received into the inventory. This applies to any products that may have been deemed as contraband or that are misbranded or counterfeit.

Any products that may be unfit for use are promptly placed into the designated quarantine area. This is to ensure these products are separated physically from the inventory until they are either disposed of or returned to the manufacturer. The term contraband in this context is a general term for any prescription drug that is misbranded, counterfeit, obtained through an act of fraud, stolen, etc. Products in inventory that expire must also be quarantined.

Other Potential Misbranding

A prescription product or device may be considered to be misbranded if any of the details that are required to appear on the labeling are not properly printed. This includes if any details are disproportionate to other words, markings, or symbols marking it difficult to read or to be understood. The New Jersey Department of Health requires that certain substances must be clearly marked with a warning that the product may be habit-forming. These products include anything considered to be narcotic or hypnotic such as barbituric acid, cannabis, coca, cocaine, morphine, etc.

Prescription Labeling Details

Products that are not labeled with their proper name are also deemed as being misbranded. This is the name that it is designated in the official compendium. When the substance has multiple ingredients, any active ingredients must be listed along with the quantity and proportion. The labeling must also contain general directions for use when it may be dangerous for children. This also applies to drugs that may pose a danger if they are taken in an incorrect dosage or if administered in an incorrect way. Any drug that is acknowledged by both the US Pharmacopoeia and the Homeopathic Pharmacopoeia must satisfy the labeling requirements of the US Pharmacopoeia unless specifically being sold as a homeopathic drug.

Role and Responsibilities of the New Jersey Pharmacy Board

When a representative that is an authorized member of the Board determines or has reason to believe that a drug or device does not meet the requirements of the Federal Food, Drug & Cosmetic Act it must be clearly marked as such. The tag or marking serves as an indicator that the product is considered to be “detained or embargoed.” These marked items are not to be removed, sold, or otherwise disposed of unless instructed to do so by the Board or a court. It the product is ultimately confirmed to be expired, misbranded, or adulterated, it will be destroyed under Board supervision.

Any representative that is an authorized member of the Board has the right to access and inspect any facility associated with drug producing, manufacturing, packaging, transporting, etc. This applies to any containers that are locked or sealed. They may confiscate or otherwise take possession of any item if needed for analysis.

In some cases, a seller of products that is subject to regulation under the Federal Food, Drug & Cosmetic Act may not be prosecuted for these types of violations. This applies when the seller receives the product in the original packaging and it has not been opened. The Board has the right to suspend or revoke licenses to operate and criminal penalties are imposed according to the New Jersey Controlled Substances Act.

Attorney Defends Allegations of Drug-Related Offenses

Joseph D. Lento has been representing clients in New Jersey that have been alleged to have committed drug-related offenses for many years. With the potentially harsh penalties that may be imposed, it is critical to retain seasoned legal counsel. Contact the office today at (888) 535-3686.

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