N.J. Admin. Code § 8:32-1.2
The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise:
"Administration supplies" means any supply associated with the administration of prescription drugs, including, but not limited to, diabetes test strips, nebulizers, syringes, and needles.
"Anti-rejection drug" means an over-the-counter drug or prescription drug that suppresses the immune system to prevent or reverse the rejection of a transplanted organ.
"Board" means the State Board of Pharmacy.
"Cancer drug" means a prescription drug that is used to treat cancer or the side effects of cancer, or that is used to treat the side effects of any other prescription drug that is used to treat cancer or the side effects of cancer.
"Commissioner" means the Commissioner of the Department of Health.
"Compounded drug" means a sterile or nonsterile compounded formulation for dispensing or administration pursuant to a prescription, that is prepared for an individual with needs that cannot be met by a commercially available prescription drug.
"Controlled dangerous substance" means the same as that term is defined at N.J.S.A. 2C:35-2.
"Correctional facility" means a county or State correctional facility, county juvenile detention facility, secure juvenile facility, Federal prison, or other comparable facility.
"Department" means the New Jersey Department of Health.
"Director" means the Director of the New Jersey Division of Taxation.
"Diversion" means the transfer of a donated drug, over-the-counter drug, or administration supply, to a non-eligible individual, without the approval of the Department.
"Division" means the New Jersey Division of Taxation.
"Donated drug" means an over-the-counter drug or prescription drug that has been donated to a redistributor, in accordance with the provisions of this chapter.
"Donor" means a drug manufacturer, wholesaler, repackager, returns processor, third-party logistics provider, health care facility, correctional facility, pharmacy, or any other person or entity that is properly licensed and authorized to possess prescription drugs, and which elects to donate over-the-counter drugs, prescription drugs, or administration supplies pursuant to this chapter.
"Drug donation program" means a program, established pursuant to the provisions of this chapter and in accordance with N.J.S.A. 24:6M-1 et seq., to accept the donation of unused over-the-counter drugs, prescription drugs, and administration supplies that would otherwise be destroyed, and which provides for the redistribution of those unused drugs and administration supplies to persons who are most in need.
"Eligible individual" means an individual or individuals who are indigent, uninsured, or enrolled in a public health benefits program, or other individuals, if a need for the donated drugs and administration supplies is not identified among persons who are indigent, uninsured, or enrolled in a public health benefits program.
"Grooming and hygiene product" means soap or cleaning solution, shampoo, toothpaste, mouthwash, anti-perspirant, suntan lotion or screen, or other hygiene product regardless of whether the item meets the definition of "over-the-counter drug."
"Health care facility" means a physician's office; a hospital; an outpatient clinic; a Federally qualified health center; a Federally qualified health center look-alike; a rural health clinic; a clinic that provides services pursuant to the Federal Ryan White HIV/AIDS Program; a mental health center or clinic; a Veterans Affairs hospital; and any other health care facility licensed pursuant to P.L. 1971, c. 136 (N.J.S.A. 26:2H-1 et seq.), or a comparable facility licensed to operate within another state.
"Indigent" means a person who has an income that is below 250 percent of the Federal poverty level.
"Out-of-State redistributor" means a health care facility, pharmacy, wholesaler, returns processor, or other person or entity that is properly licensed to operate in a state other than New Jersey, and is authorized to dispense over-the-counter drugs and prescription drugs, and which agrees to accept, repackage, transfer to other redistributors, and, if otherwise authorized by law, dispense donated drugs and administration supplies to eligible individuals pursuant to a prescription drug donation program established pursuant to the laws of the state in which the person or entity is located.
"Over-the-counter drug" means a drug that includes a label that meets the requirements at 21 CFR 201.66, as amended and supplemented, including:
"Prescriber" means a licensed physician, physician assistant, or advanced practice nurse,or any other person who is authorized by the appropriate State professional andoccupational licensing board to prescribe drugs and devices as provided by law.
"Prescription drug" means any drug, intended for use in humans, which is required byFederal or State law or regulation to be dispensed only pursuant to a prescription."Prescription drug" includes cancer drugs and anti-rejection drugs, but does not include,any controlled dangerous substances or compounded drugs.
"Redistributor" means a health care facility, pharmacy, wholesaler, returns processor, or any other person or entity that is properly licensed and authorized to dispense over-the-counter drugs and prescription drugs, and which agrees to accept, repackage, transfer to other redistributors, and, if otherwise authorized by law, dispense donated drugs and administration supplies to eligible individuals pursuant to this chapter. "Redistributor" includes an out-of-State redistributor.
"Returns processor" shall mean the same as that term is defined at 21 U.S.C. § 360eee(18). "Returns processor" includes a reverse distributor.
"Tamper-evident packaging" means a package or container that has an immediate, outer, or secondary seal that must be broken in order to gain access to the container's contents. "Tamper-evident packaging" includes a partially used single-unit dose or blister pack and bottles or vials sealed in pouches or with tamper-evident tape.
"Third-party intermediary" means an organization that is not a wholesaler or third-party logistics provider, and that facilitates the donation or transfer of over-the-counter drugs, prescription drugs, and administration supplies for a drug donation program established pursuant to this chapter, but which does not take possession or ownership of the drugs.
"Transaction date" means the date at which ownership of the drug was donated or transferred between two participants of the program as established by contract or other arrangement. If no such contract or arrangement exists, the transaction date shall be the date the drug was accepted into inventory by the redistributor.
N.J. Admin. Code § 8:32-1.2