Skip to main content

Meeting of the Board of Regents | April 2003

Tuesday, April 1, 2003 - 7:25am

 

THE STATE EDUCATION DEPARTMENT / THE UNIVERSITY OF THE STATE OF NEW YORK / ALBANY, NY 12234

TO:

The Honorable the Members of the Board of Regents

FROM:

Johanna Duncan-Poitier

COMMITTEE:

Professional Practice

TITLE OF ITEM:

Proposed Amendment to the Rules of the Board of Regents and the Regulations of the Commissioner of Education Relating to the Practice of Pharmacy and the Registration of Pharmacies

DATE OF SUBMISSION:

April 9, 2003

PROPOSED HANDLING:

Discussion

RATIONALE FOR ITEM:

To Implement Policy and Statute

STRATEGIC GOAL:

Goal 3

AUTHORIZATION(S):

SUMMARY:

Attached for discussion is a proposed amendment to subparagraph (i) of paragraph (21) of subdivision (a) of section 29.7 of the Rules of the Board of Regents, amendment to subparagraph (i) of paragraph (8) of subdivision (b) of section 63.6 and paragraph (6) of subdivision (b) of section 63.8 of the Regulations of the Commissioner of Education, and promulgation of paragraph (9) of subdivision (b) of section 63.6 of the Regulations of the Commissioner of Education, relating to the practice of pharmacy and the registration of pharmacies. Supporting materials for the proposed amendment are available from the Secretary of the Board of Regents.

The purpose of the proposed amendment is to establish requirements relating to the counseling of patients by pharmacists and the maintenance of drug retail price lists by pharmacies.

A Notice of Proposed Rule Making concerning the proposed amendment will be published in the State Register no later than April 23, 2003. It is recommended that formal action on the proposed amendment be taken at the June meeting of the Board of Regents.

 

Attachment

 

 AMENDMENT TO THE RULES OF THE BOARD OF REGENTS AND THE REGULATIONS OF THE COMMISSIONER OF EDUCATION

Pursuant to sections 207, 6504, 6506, 6507, 6509, 6801, 6806, 6808-b, and 6826 of the Education Law.

1. Subparagraph (i) of paragraph (21) of subdivision (a) of section 29.7 of the Rules of the Board of Regents is amended, effective July 10, 2003, as follows:

(i) Subject to the limitations set forth in subparagraph (ii) of this paragraph, an unlicensed may assist a pharmacist in the dispensing of drugs by:

(a) . . .

(b) . . .

(c) . . .

(d) . . .

(e) . . .

(f) . . .

(g) . . .

(h) . . .

(i) . . .

(j) handling or delivering completed prescriptions to the patient or the person authorized to act on behalf of the patient [after the pharmacist or pharmacy intern has met the requirements of section 63.6(b)(8) of this Title regarding the offering of counseling to such person] and, in accordance with section 63.6(b)(8) of this Title, advising the patient or person authorized to act on behalf of the patient of the availability of counseling to be conducted by the pharmacist or pharmacy intern.

2. Subparagraph (i) of paragraph (8) of subdivision (b) of section 63.6 of the Regulations of the Commissioner of Education is amended, effective July 10, 2003, as follows:

(i) On-premises delivery. For a prescription that is delivered to [the] a patient or [the] a person authorized to act on behalf of the patient on the premises of the pharmacy, the pharmacist or pharmacy intern shall meet the requirements of this subparagraph. For a prescription that is delivered to [the] a patient or [the] a person authorized to act on behalf of the patient off the premises of [the] a pharmacy through mail delivery, a delivery service or otherwise, the pharmacist or pharmacy intern shall meet the requirements of subparagraph (ii) of this paragraph.

(a) Prior to dispensing a prescription for the first time for a new patient of the pharmacy or a prescription for a new medication for an existing patient of the pharmacy and/or a change in the dose, strength, route of administration or directions for use of an existing prescription previously dispensed for an existing patient of the pharmacy, a pharmacist or pharmacy intern providing prescription services shall be required to personally [offer to] counsel each patient or person authorized to act on behalf of [the] a patient who presents a prescription, consistent with the provisions of section 29.1(b)(8) of this Title, in person in a face to face meeting whenever practicable, or by telephone, matters which in the exercise of the pharmacist�s or pharmacy intern�s professional judgment, the pharmacist or pharmacy intern deems appropriate, which may include:

(1) the name and description of the medication and known indications;

(2) . . .

(3) . . .

(4) . . .

(5) . . .

(6) . . .

(7) . . .

(8) . . .

(b) The [offer to counsel] counseling of [the] a patient or person authorized to act on behalf of [the] a patient pursuant to clause (a) of this subparagraph shall be provided personally by the pharmacist or the pharmacy intern and shall not be delegated to an individual not authorized to practice pharmacy under a license or limited permit.

[(c) . . .]

[(d)] (c) In the event a patient [chooses not] refuses to supply information necessary for maintenance of a medication profile, or to accept counseling, as prescribed in clause (a) of this subparagraph, a pharmacist or pharmacy intern may fill a prescription as presented, without having violated the requirements of this subparagraph, provided that the refusal to provide such information or accept counseling is documented in the records of the pharmacy.

(d) In the event a patient or a person authorized to act on behalf of a patient seeks to obtain a refill of an existing prescription previously filled by the pharmacy or an authorization for continuation of an existing therapy, a pharmacist or pharmacy intern shall be available to provide counseling to the patient or person authorized to act on behalf of a patient, upon such person's request. In such circumstances and consistent with the requirements of paragraph (21) of subdivision (a) of section 29.7 of this Title, an offer to counsel the patient or a person authorized to act on behalf of a patient may be conveyed on behalf of the pharmacist or pharmacy intern by an unlicensed assistant. Such counseling shall be conducted only by a pharmacist or pharmacy intern.

(e) . . .

3. Paragraph (9) of subdivision (b) of section 63.6 of the Regulations of the Commissioner of Education is added, effective July 10, 2003, as follows:

(9) Drug retail price lists. Every registered pharmacy that sells prescription medications at retail shall meet the requirements of section 6826 of the Education Law. In accordance with subdivision (4) of section 6826 of the Education Law, such registered pharmacies shall have a sign notifying people of the availability of the drug retail price list, conspicuously posted at or adjacent to the place in the pharmacy where prescriptions are presented for compounding and dispensing, in the waiting area for customers, or in the area where prescribed drugs are delivered. The sign shall state in bold, block letters of at least one inch in height: "Drug Retail Price List Available Upon Request". Such registered pharmacies that offer to dispense prescription drugs to consumers through a website on the Internet shall post on such website a notice of the availability of the drug retail price list and a toll-free telephone number to obtain the list. Such registered pharmacies that offer to dispense prescription drugs to consumers through mail order shall include a printed notice with each delivery of a prescription drug informing the consumer of the availability of the drug retail price list and a toll-free telephone number to obtain the list.

4. Paragraph (6) of subdivision (b) of section 63.8 of the Regulations of the Commissioner of Education is amended, effective July 10, 2003, as follows:

(6) Additional registration requirements for nonresident establishments that are pharmacies.

(i) [In order to be registered, nonresident] Toll-free number. Nonresident establishments that are pharmacies shall provide a toll-free telephone number that is available during normal business hours at least 40 hours per week, to enable communication between a patient in New York State and a pharmacist at the pharmacy who has access to the patient's records, and shall place such toll free number on a label affixed to each drug or device container.

(ii) Drug retail price lists. Nonresident establishments that are pharmacies that sell prescription medications at retail shall meet the requirements of subdivisions (1), (2), (3), and (5) of section 6826 of the Education Law for a drug retail price list. Such pharmacies that offer to dispense prescription drugs to consumers in New York State through a website on the Internet shall post on such website a notice of the availability of the drug retail price list and a toll-free telephone number to obtain the list. Such registered pharmacies that offer to dispense prescription drugs to consumers in New York State through mail order shall include a printed notice with each delivery of a prescription drug informing the consumer of the availability of the drug retail price list and a toll-free telephone number to obtain the list.