Bill Text: NY A01615 | 2015-2016 | General Assembly | Introduced
Bill Title: Enacts requirements relating to the safe handling of prescription drug samples by certain health care professionals; requires maintenance of certain records and information regarding samples received and distributed including expiration dates.
Spectrum: Partisan Bill (Democrat 16-0)
Status: (Introduced - Dead) 2016-01-28 - advanced to third reading cal.348 [A01615 Detail]
Download: New_York-2015-A01615-Introduced.html
S T A T E O F N E W Y O R K ________________________________________________________________________ 1615 2015-2016 Regular Sessions I N A S S E M B L Y January 12, 2015 ___________ Introduced by M. of A. GOTTFRIED, GALEF, DINOWITZ, PAULIN, CAHILL, COOK, BRENNAN, ROSENTHAL, ENGLEBRIGHT -- Multi-Sponsored by -- M. of A. COLTON, FARRELL, JAFFEE, LAVINE, PERRY -- read once and referred to the Committee on Health AN ACT to amend the public health law, in relation to reducing health risks involved with receipt, handling and distribution of samples of prescription drug products THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM- BLY, DO ENACT AS FOLLOWS: 1 Section 1. The public health law is amended by adding a new article 2 33-B to read as follows: 3 ARTICLE 33-B 4 THE PRESCRIPTION DRUG SAMPLE SAFETY ACT 5 SECTION 3398. REQUIREMENTS FOR THE SAFE HANDLING OF PRESCRIPTION DRUG 6 SAMPLES. 7 S 3398. REQUIREMENTS FOR THE SAFE HANDLING OF PRESCRIPTION DRUG 8 SAMPLES. 1. A PERSON AUTHORIZED TO DISPENSE DRUGS PURSUANT TO PARAGRAPH 9 B OF SUBDIVISION ONE OF SECTION SIXTY-EIGHT HUNDRED SEVEN OF THE EDUCA- 10 TION LAW SHALL ESTABLISH AND ADHERE TO THE FOLLOWING PROCEDURES AND 11 REQUIREMENTS REGARDING THE HANDLING OF SUCH DRUGS: 12 (A) SAMPLES SHALL BE PROPERLY LOGGED IN (INCLUDING IDENTIFICATION OF 13 THE MANUFACTURER OR ENTITY SUPPLYING OR PROVIDING SUCH SAMPLES, THE 14 DATE, TYPE AND THE AMOUNT OF DRUG RECEIVED AND EXPIRATION DATES, IF 15 ANY), LABELED, STORED, SECURED AND TRACKED TO PREVENT UNAUTHORIZED 16 ACCESS AND LOSS; 17 (B) PRESCRIBERS SHALL MAINTAIN DOCUMENTATION OF THE DISTRIBUTION OF 18 SAMPLES IN PATIENTS' MEDICAL RECORDS, INCLUDING THE DATE, TYPE, AND 19 AMOUNT DISPENSED, AND OBTAIN THE INFORMED CONSENT OF PATIENTS RECEIVING 20 SAMPLE PRODUCTS; 21 (C) SAMPLES SHALL BE LABELED WITH APPROPRIATE PRESCRIBING INFORMATION; EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD02421-01-5 A. 1615 2 1 (D) PRESCRIBERS SHALL REGULARLY REVIEW SAMPLE EXPIRATION DATES AND 2 REMOVE OUTDATED PRODUCTS; 3 (E) PRESCRIBERS SHALL MAINTAIN PROPER DOCUMENTATION OF RECIPIENTS OF 4 SAMPLE PRODUCTS FOR PATIENT CONTACT IN THE EVENT OF A RECALL OR 5 LATER-DISCOVERED INTERACTION WARNING; AND 6 (F) PRESCRIBERS SHALL MAINTAIN A RECORD OF THE DISPOSAL, DESTRUCTION, 7 OR RETURN OF EXPIRED OR RECALLED SAMPLE PRODUCTS. 8 2. THE COMMISSIONER SHALL PROMULGATE REGULATIONS NECESSARY TO IMPLE- 9 MENT AND ENFORCE THIS SECTION. 10 S 2. This act shall take effect on the one hundred eightieth day after 11 it shall have become a law.