(a) All original or refill prescription drug containers utilized in a traditional dispensing system shall be labeled as follows: - (ii) brand or generic name of the drug product dispensed, unless otherwise specified;
- (iii) drug strength and quantity;
- (iv) the name, address, and telephone number of the pharmacy;
- (v) the practitioner's name;
- (vi) the serialized number of the prescription;
- (vii) the date the prescription was filled or refilled;
- (viii) purpose for use where appropriate;
- (ix) directions for use; including accessory cautionary information as appropriate for patient safety;
- (x) the identifying initials of the dispensing pharmacist; and
- (xi) any other information required by federal or state law.
(b) All original or refill prescription drug containers utilized in a traditional dispensing system shall be labeled with the product's physical description, including any identification code that may appear on the tablets and capsules. A waiver will be granted for new drugs for the first one hundred-twenty (120) days on the market and ninety (90) days for drugs which the national reference file has no description on file.
(c) All single unit dose or unit of use packaging shall be labeled as follows: - (i) Brand name and/or generic name of the prescription drug;
- (iii) Manufacturer's lot number;
- (iv) Manufacturer's expiration date. If prepackaged or repackaged by the pharmacy, the expiration date shall be the lesser of the manufacturer's expiration date or twelve (12) months from the date of prepackaging or repackaging;
- (v) All unit of use packaging dispensed shall include the following information on the label, in addition to that required by this chapter:
- (A) Name, address and telephone number of the pharmacy;
- (D) Name of the practitioner;
- (G) Initials of dispensing pharmacist;
- (H) Accessory cautionary labels for patient safety; and
- (I) Quantity of medication.
- (vi) All unit of use packaging dispensed by a retail pharmacy to residents of long-term care facilities, as defined in Chapter 15 of these rules, as well as prescription drugs dispensed from hospital emergency room departments, as described in Chapter 12 of these rules, shall be labeled with the product's physical description, including any identification code that may appear on the tablets and capsules.
Amended, Eff. 10/31/2017.
Amended, Eff. 12/19/2018.