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

6/1/11 N.Y. St. Reg. EDU-22-11-00005-P

NEW YORK STATE REGISTER

VOLUME XXXIII, ISSUE 22

June 01, 2011

RULE MAKING ACTIVITIES

EDUCATION DEPARTMENT

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

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

Customized Packaging of Prescription Drugs

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

1. Paragraph (15) of subdivision (a) of section 29.7 of the Rules of the Board of Regents is amended, effective August 10, 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 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.

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

Christine Moore, New York State Education Department, 89 Washington Avenue, Room 146, Albany, New York 12234, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Peg Rivers, New York State Education Department, 89 Washington Avenue, Room 979, Albany, New York 12234, [phone], email: [e-mail]

Public comment will be received until:

45 days after publication of this notice.

Regulatory Impact Statement

1. STATUTORY AUTHORITY:

Section 207 of the Education Law grants general rule-making authority to the Board of Regents to carry into effect the laws and policies of the State relating to education.

Section 6504 of the Education Law authorizes the Board of Regents to supervise the admission to and regulation of the practice of the professions.

Subdivision (1) of section 6506 of the Education Law authorizes the Board of Regents to promulgate rules to supervise the practice of the professions.

Subdivision (1) of section 6508 of the Education Law provides that state boards for the professions shall assist the Board of Regents and Department on matters of professional licensing.

Subdivision (9) of section 6509 of the Education Law authorizes the Board of Regents to promulgate rules defining unprofessional conduct in the professions.

Subdivision (1) of section 6510 the Education Law establishes the labeling requirements for prescriptions.

2. LEGISLATIVE OBJECTIVES:

The proposed amendment authorizes pharmacists to repackage drugs in customized patient packaging provided that certain requirements are met. If such conditions are not met, the proposed amendment defines such pharmacy practice as unprofessional conduct. The proposal incorporates recognized practice standards and protections for purity, potency and labeling of medications.

3. NEEDS AND BENEFITS:

The proposed amendment authorizes medications to be repackaged in customized patient medication packages, with the consent of the patient, the patient's caregiver, or the prescriber. The proposal would encourage patient compliance with complex medication protocols.

4. COSTS:

(a) There are no additional costs to state government.

(b) There are no additional costs to local government.

(c) Cost to private regulated parties. The proposed amendment will not impose any additional costs on private regulated parties. Instead, the proposed amendment may provide cost-savings to regulated parties.

(d) There are no additional costs to the regulating agency.

5. LOCAL GOVERNMENT MANDATES:

The proposed amendment relates solely to the repackaging of drugs in customized patient medication packages and the definition of unprofessional conduct in the practice of pharmacy and does not impose any programs, service, duty, or responsibility upon local governments.

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 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.

7. DUPLICATION:

The proposed amendment does not duplicate other existing state or federal requirements.

8. ALTERNATIVES:

There are no viable alternatives to the proposed amendment and none were considered.

9. FEDERAL STANDARDS:

Federal standards do not apply, nor does the proposal exceed federal standards.

10. COMPLIANCE SCHEDULE:

The proposed amendment is intended to become effective August 10, 2011.

Regulatory Flexibility Analysis

(a) Small Businesses:

1. EFFECT OF RULE:

The proposed amendment authorizes, but does not require, pharmacists to repackage drugs in customized patient packaging provided that certain requirements are met. If such conditions are not met, the proposed amendment defines such pharmacy practice as unprofessional conduct. The proposal incorporates recognized practice standards and protections for purity, potency and labeling of medications. The proposed amendment may impact small businesses, i.e., pharmacies across the State with fewer than 100 employees.

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 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.

3. PROFESSIONAL SERVICES:

The proposed regulation will not require pharmacies to engage professional services.

4. COMPLIANCE COSTS:

Because the packaging of medications in customized patient medication packages is voluntary, there is no obligation on the part of pharmacies to participate, and, therefore, there are no mandated compliance costs. For those pharmacies that choose to make such packaging available to their customers, the recordkeeping and labeling costs are minimal since the pharmacies would be required to keep the same or similar information even if the drugs were dispensed in the traditional manner. The costs for the technology to provide customized packaging for prescription drugs is wide ranging. Manual systems can be obtained for approximately $1,000, while very sophisticated systems used for high-volume, rapid dispensing can cost up to $200,000. However, costs per unit decrease over time with volume as this form of packaging replaces traditional dispensing in vials that can cost as much as 50 cents per vial.

5. ECONOMIC AND TECHNOLOGICAL FEASIBILITY:

For those pharmacies, including those that are classified as small businesses, that choose to make customized patient medication packaging available to their clients, the proposed regulation will likely be implemented by the use of available technology. See above "Compliance Costs" for the economic impact of the regulation.

6. MINIMIZING ADVERSE IMPACT:

The proposed amendment authorizes medications to be repackaged in customized patient medication packages, with the consent of the patient, the patient's caregiver, or the prescriber. The proposal would encourage patient compliance with complex medication protocols. The labeling and recordkeeping requirements listed above are necessary to comply with existing laws and standards and to ensure patient safety. Additionally, because the use of customized packaging is voluntary on the part of the pharmacy, individual pharmacies have the option of choosing not to provide such packaging.

7. SMALL BUSINESS PARTICIPATION:

Comments on the proposed rule were solicited from statewide organizations representing all parties having an interest in the practice of pharmacy, nursing and medicine. Included in this group were members of the State Board of Pharmacy, educational institutions and professional associations representing the pharmacy, nursing and medical professions, such as the Pharmacists Society of the State of New York, the New York State Council of Health System Pharmacists, and the New York State Board for Nursing. These groups, which include representatives of small businesses, have been provided notice of the proposed rule making and opportunity to comment on the regulations.

(b) Local Governments:

The proposed amendment relates solely to the repackaging of drugs in customized patient medication packages and the definition of unprofessional conduct in the practice of pharmacy and does not impose any programs, service, duty, or responsibility upon local governments. Because it is evident from the nature of the proposed rule that it does not affect local governments, no further steps were needed to ascertain that fact and none were taken. Accordingly a regulatory flexibility analysis for local governments is not required and one has not been prepared.

Rural Area Flexibility Analysis

1. TYPES AND ESTIMATED NUMBER OF RURAL AREAS:

The proposed rule would apply to the 44 rural counties with less than 200,000 inhabitants and the 71 towns in urban counties with a population density of 150 per square mile or less. Of the 22,344 pharmacists registered by the State Education Department, 2,821 pharmacists report their permanent address of record is in a rural county. In addition, the rule would apply to pharmacies, 779 of which are located in rural counties.

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 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.

3. COSTS:

The proposed amendment does not impose any additional costs on regulated parties.

4. MINIMIZING ADVERSE IMPACT:

The rules make no exception for individuals or pharmacies in rural areas. The Department has determined that the proposed regulation should apply to all pharmacists and pharmacies, no matter their geographic location, to ensure a standard of practice across the State. Because of the nature of the proposed rule, alternative approaches for rural areas were not considered.

5. RURAL AREA PARTICIPATION:

Comments on the proposed rule were solicited from statewide organizations representing all parties having an interest in the practice of pharmacy, nursing and medicine. Included in this group were members of the State Board of Pharmacy, educational institutions and professional associations representing the pharmacy, nursing and medical professions, such as the Pharmacists Society of the State of New York, the New York State Council of Health System Pharmacists, and the New York State Board for Nursing. These groups, which have representation in rural areas, have been provided notice of the proposed rule making and opportunity to comment on the regulations.

Job 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. Because it is evident from the nature of the proposed amendment that it will not affect job and employment opportunities, no affirmative steps were needed to ascertain that fact and none were taken. Accordingly, a job impact statement is not required and one has not been prepared.