EDU-22-11-00005-RP Customized Packaging of Prescription Drugs

8/31/11 N.Y. St. Reg. EDU-22-11-00005-RP

NEW YORK STATE REGISTER

VOLUME XXXIII, ISSUE 35

August 31, 2011

RULE MAKING ACTIVITIES

EDUCATION DEPARTMENT

REVISED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. EDU-22-11-00005-RP

Customized Packaging of Prescription Drugs

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following revised rule:

Proposed Action:

Amendment of section 29.7 of Title 8 NYCRR.

Statutory authority:

Education Law, sections 207, 6504, 6506(1), 6508(1), 6509(9) and 6510(1)

Subject:

Customized packaging of Prescription Drugs.

Purpose:

Authorizes pharmacists to repackage drugs in customized patient packaging provided that certain requirements are met.

Text of revised rule:

Paragraph (15) of subdivision (a) of section 29.7 of the Rules of the Board of Regents is amended, effective November 9, 2011, as follows:

(15)(i) Repacking of drugs in a pharmacy, except by a pharmacist or under his/her immediate and personal supervision. Labels on repacked drugs shall bear sufficient information for proper identification and safety. A repacking record shall be maintained, including the name, strength, lot number, quantity and name of the manufacturer and/or distributor of the drug repacked, the date of the repacking, the number of packages prepared, the number of dosage units in each package, the signature of the person performing the packaging operation, the signature of the pharmacist who supervised the repacking, and such other identifying marks added by the pharmacy for internal recordkeeping purposes. Drugs repacked for in-house use only shall have an expiration date of 12 months, or 50 percent of the time remaining to the manufacturer's expiration date, whichever is less, from the date of repacking. For the repacking of drugs by manufacturers and wholesalers, the provisions of parts 210 and 211 of title 21, Code of Federal Regulations (1984 edition, Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402: 1984, available at New York State Board of Pharmacy, [Room 3035, Cultural Education Center, Albany, NY 12230] 89 Washington Avenue, 2nd Floor, Albany, NY 12234), shall apply. Repacking records shall be maintained for five years and shall be made available to the department for review and copying.

(ii) Repacking drugs in customized patient medication packages (patient med-pak or patient medication package) unless the following conditions are complied with:

(a) medications are packaged in moisture-proof containers that are either non-reclosable or are designed to show evidence of having been opened;

(b) medications are dispensed in containers that bear a label affixed to the immediate container in which the medications are dispensed in accordance with section 6810(1) of the Education Law. Such label shall include:

(1) all information required by Education Law section 6810(1);

(2) the name, strength, physical description or identification, and quantity of each medication;

(3) the address and telephone number of the dispenser;

(4) an expiration date for the customized patient medication package, which shall not be longer than the shortest recommended expiration date of the medications included therein, provided that in no event shall the expiration date be more than 60 days from the date of preparation of the package and shall not exceed the shortest expiration date on the original manufacturer's bulk containers for the dosage forms included therein;

(5) a separate identifying serial number for each of the prescription orders for each of the drug products contained in the customized patient medication package and, unless such number provides complete information about the customized patient medication package, a serial number for the customized patient medication package itself; and

(6) any other information, including storage instructions or any statements, or warnings required for the medications contained in the package.

(c) medications shall not be repackaged for or reissued to any patient other than to the patient for whom they are originally dispensed;

(d) medications shall not be dispensed in customized patient medication packages, without the consent of the patient, the patient's caregiver, or the prescriber, and the patient or caregiver shall be properly instructed in the use of such packages, in how to identify each medication, and in the steps to be taken in the event one of the medications is discontinued or the therapy otherwise altered;

(e) controlled substances shall not be dispensed in customized patient medication packages;

(f) medications that are unstable or therapeutically incompatible shall not be dispensed in customized patient medication packages; and

(g) a record of each customized patient medication package shall be maintained by the pharmacist. Each record shall contain:

(1) the name and address of the patient;

(2) the serial number of the prescription order for each medication contained therein, or other means of individualized tracking system acceptable to the Department;

(3) the name of the manufacturer or labeler and the lot number for each medication contained therein;

(4) information identifying or describing the design, characteristics, or specifications of the customized patient medication package sufficient to allow subsequent preparation of an identical customized patient medication package for the patient;

(5) the date of preparation of the customized patient medication package and the expiration date that was assigned;

(6) any special labeling instructions; and

(7) the name or initials of the pharmacist who prepared the customized patient medication package.

Revised rule compared with proposed rule:

Substantial revisions were made in section 29.7(a)(15)(ii).

Text of revised proposed rule and any required statements and analyses may be obtained from

Chris Moore, State Education Department, Office of Counsel, State Education Building Room 146, 89 Washington Ave., Albany, NY 12234, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Douglas Lentivech, Deputy Commissioner for the Professions, State Education Department, State Education Building, 2M, 89 Washington Ave., Albany, NY 12234, [phone], email: [e-mail]

Public comment will be received until:

30 days after publication of this notice.

Revised Regulatory Impact Statement

Since publication of a Notice of Proposed Rule Making in the State Register on June 1, 2011, the proposed amendment has been substantially revised as follows.

Section 29.2(a)(15)(ii)(g)(3) has been revised to require that pharmacists maintain a record of the lot number for each medication contained in a customized patient medication package.

The above change requires that the Paperwork section of the previously published Regulatory Impact Statement be revised to read as follows:

6. PAPERWORK:

The proposed amendment requires that medications in customized patient medication packages be dispensed in containers that bear a label affixed to the immediate container in accordance with section Education Law section 6810(1). The label shall include the following information:

(1) all information required by Education Law section 6810(1);

(2) the name, strength, physical description or identification, and quantity of each medication;

(3) the address and telephone number of the dispenser;

(4) an expiration date for the customized patient medication package, which shall not be longer than the shortest recommended expiration date of the medications included therein, provided that in no event shall the expiration date be more than 60 days from the date of preparation of the package and shall not exceed the shortest expiration date on the original manufacturer's bulk containers for the dosage forms included therein;

(5) a separate identifying serial number for each of the prescription orders for each of the drug products contained in the customized patient medication package and, unless such number provides complete information about the customized patient medication package, a serial number for the customized patient medication package itself; and

(6) any other information, including storage instructions or any statements, or warnings required for the medications contained in the package.

A record of each customized patient medication package shall also be maintained by the pharmacist. The record must contain the following information:

(1) the name and address of the patient;

(2) the serial number of the prescription order for each medication contained therein, or other means of individualized tracking system acceptable to the Department;

(3) the name of the manufacturer or labeler and the lot number for each medication contained therein;

(4) information identifying or describing the design, characteristics, or specifications of the customized patient medication package sufficient to allow subsequent preparation of an identical customized patient medication package for the patient;

(5) the date of preparation of the customized patient medication package and the expiration date that was assigned;

(6) any special labeling instructions; and

(7) the name or initials of the pharmacist who prepared the customized patient medication package.

The patient or caregiver must be properly instructed in the use of such packages, in how to identify each medication, and in the steps to be taken in the event one of the medications is discontinued or the therapy otherwise altered.

Revised Regulatory Flexibility Analysis

Since publication of a Notice of Proposed Rule Making in the State Register on June 1, 2011, the proposed amendment has been substantially revised as set forth in the Statement Concerning the Regulatory Impact Statement filed herewith.

The aforesaid revision requires that the Compliance section of the previously published Regulatory Flexibility Analysis for Small Businesses and Local Government be revised to read as follows:

2. COMPLIANCE REQUIREMENTS:

The proposed amendment requires that medications in customized patient medication packages be dispensed in containers that bear a label affixed to the immediate container in accordance with section Education Law section 6810(1). The label shall include the following information:

(1) all information required by Education Law section 6810(1);

(2) the name, strength, physical description or identification, and quantity of each medication;

(3) the address and telephone number of the dispenser;

(4) an expiration date for the customized patient medication package, which shall not be longer than the shortest recommended expiration date of the medications included therein, provided that in no event shall the expiration date be more than 60 days from the date of preparation of the package and shall not exceed the shortest expiration date on the original manufacturer's bulk containers for the dosage forms included therein;

(5) a separate identifying serial number for each of the prescription orders for each of the drug products contained in the customized patient medication package and, unless such number provides complete information about the customized patient medication package, a serial number for the customized patient medication package itself; and

(6) any other information, including storage instructions or any statements, or warnings required for the medications contained in the package.

A record of each customized patient medication package shall also be maintained by the pharmacist. The record must contain the following information:

(1) the name and address of the patient;

(2) the serial number of the prescription order for each medication contained therein, or other means of individualized tracking system acceptable to the Department;

(3) the name of the manufacturer or labeler and the lot number for each medication contained therein;

(4) information identifying or describing the design, characteristics, or specifications of the customized patient medication package sufficient to allow subsequent preparation of an identical customized patient medication package for the patient;

(5) the date of preparation of the customized patient medication package and the expiration date that was assigned;

(6) any special labeling instructions; and

(7) the name or initials of the pharmacist who prepared the customized patient medication package.

The patient or caregiver must be properly instructed in the use of such packages, in how to identify each medication, and in the steps to be taken in the event one of the medications is discontinued or the therapy otherwise altered.

Revised Rural Area Flexibility Analysis

Since publication of a Notice of Proposed Rulemaking in the State Register on June 1, 2011, the proposed amendment has been substantially revised as set forth in the Statement Concerning the Regulatory Impact Statement filed herewith.

The aforesaid revisions requires the Reporting, Recordkeeping and Other Compliance Requirements; and Professional Services section in the previously published Rural Area Flexibility Analysis be revised to read as follows:

2. REPORTING, RECORDKEEPING AND OTHER COMPLIANCE REQUIREMENTS; AND PROFESSIONAL SERVICES:

The proposed amendment requires that medications in customized patient medication packages be dispensed in containers that bear a label affixed to the immediate container in accordance with section Education Law section 6810(1). The label shall include the following information:

(1) all information required by Education Law section 6810(1);

(2) the name, strength, physical description or identification, and quantity of each medication;

(3) the address and telephone number of the dispenser;

(4) an expiration date for the customized patient medication package, which shall not be longer than the shortest recommended expiration date of the medications included therein, provided that in no event shall the expiration date be more than 60 days from the date of preparation of the package and shall not exceed the shortest expiration date on the original manufacturer's bulk containers for the dosage forms included therein;

(5) a separate identifying serial number for each of the prescription orders for each of the drug products contained in the customized patient medication package and, unless such number provides complete information about the customized patient medication package, a serial number for the customized patient medication package itself; and

(6) any other information, including storage instructions or any statements, or warnings required for the medications contained in the package.

A record of each customized patient medication package shall also be maintained by the pharmacist. The record must contain the following information:

(1) the name and address of the patient;

(2) the serial number of the prescription order for each medication contained therein, or other means of individualized tracking system acceptable to the Department;

(3) the name of the manufacturer or labeler and the lot number for each medication contained therein;

(4) information identifying or describing the design, characteristics, or specifications of the customized patient medication package sufficient to allow subsequent preparation of an identical customized patient medication package for the patient;

(5) the date of preparation of the customized patient medication package and the expiration date that was assigned;

(6) any special labeling instructions; and

(7) the name or initials of the pharmacist who prepared the customized patient medication package.

The patient or caregiver must be properly instructed in the use of such packages, in how to identify each medication, and in the steps to be taken in the event one of the medications is discontinued or the therapy otherwise altered.

Revised Job Impact Statement

Since publication of a Notice of Proposed Rule Making in the State Register on June 1, 2011, the proposed amendment has been substantially revised as set forth in the Statement Concerning the Regulatory Impact Statement.

The proposed amendment relates to the definition of unprofessional conduct in the practice of the profession of pharmacy and will not adversely impact jobs and employment opportunities. The proposed amendment, as so revised, will not have an adverse impact on jobs or employment opportunities. Because it is evident from the nature of the revised proposed amendment that it will have a positive impact, or no impact, on jobs or employment opportunities, no further steps were needed to ascertain those facts and none were taken. Accordingly, a job impact statement is not required and one has not been prepared.

Assessment of Public Comment

Since publication of a Notice of Proposed Rule making in the June 1, 2011 State Register, the State Education Department received the following comments:

1. COMMENT:

Support was expressed for the proposed rule as a means to ensure that patients are able to adhere to their prescribed medication schedules and thereby improve their health outcomes and lower overall health care costs. Medication adherence is of utmost importance when trying to treat and monitor a patient's drug therapy and overall health. Many patients, especially those with chronic disease such as hypertension, diabetes and asthma (and others) do not take their medications on schedule. This is compounded in patients who have multiple diseases/conditions and patients who are elderly, debilitated or have critically important conditions such as HIV/AIDS. Many of these patients are treated with several medications creating a monumental task for some patients to stay on schedule. The costs to the health care system for this rule are minimal and are far outweighed by the improved benefits to patients and the health care system.

DEPARTMENT RESPONSE:

The Department concurs with the comment.

2. COMMENT:

While generally supporting the proposal to authorize the use of customized patient medication packages, one comment urged the Department to include in the records a pharmacist must maintain the lot number of each medication contained in each such package. The comment indicates that "ready access to this product information can literally be a life-saver in the event of a recall of contaminated or mislabeled medications."

DEPARTMENT RESPONSE:

The Department concurs that requiring pharmacists to maintain records of the lot numbers of medications contained in customized patient packages will enhance public safety. The proposed rule has been revised accordingly.