May 16, 2012
PRESCRIPTION DRUG LABELLING LAW
By: Hendrik DeBoer, Research Fellow
You asked for a summary of the law regarding (1) prescription drug labeling and (2) the substitution of generic drugs for brand name drugs.
State law requires pharmacists to attach a label to any prescription drug they sell or dispense. The label must include certain information about the drug, the pharmacist and the prescriber.
State law allows pharmacists to substitute generic drugs for prescribed brand name drugs. These generic drugs must be (1) therapeutically equivalent to the brand name drug in the pharmacist's professional opinion and (2) less expensive than the brand name drug.
DRUG LABELING LAW
State law requires pharmacists to attach a label to any prescription drug that they sell or dispense. This label must include:
1. the pharmacy's name and address;
2. the full name of the patient (or patient's owner in the case of an animal);
3. the last name of the physician or other health care professional who wrote the prescription;
4. the directions specified in the prescription;
5. the serial number of the prescription;
6. the date of filling or refilling;
7. any cautionary statement required by law;
8. the quantity of the drug contained;
9. a prominently printed expiration date; and
10. the name and place of business of the manufacturer and, if different, the name and place of business of the packer or distributor (CGS § 20-615, § 20-617, § 21a-106, § 21a-109, § 21a-256; Conn. Agencies Regs. §§ 20-576-25 to 20-576-27).
GENERIC DRUG SUBSTITUTION
State law allows a pharmacist, unless instructed otherwise by the purchaser or the prescribing physician, to substitute a generic drug with the same strength, quantity, dose, and dosage form as a prescribed brand name drug. The generic drug, in the pharmacist's professional opinion, must be therapeutically equivalent to the brand name drug. The substitution must result in a cost savings for the purchaser and the pharmacist must disclose the amount of the savings at the request of the patient. (CGS § 20-619(b), (c), (e)).
Unless directed otherwise by the prescribing physician, when the pharmacist dispenses a substitute generic drug, he or she must label the prescription container with the name of that drug and the name of the drug manufacturer or distributor (CGS § 20-619(f)).