VOLUME 48, ISSUE 7
April 4, 2016 Rule Proposals
Law and Public Safety
Division of Consumer Affairs
Board of Pharmacy
Proposed Amendments: N.J.A.C. 13:39-5.7, 5.8, and 6.2
Proposed New Rule: N.J.A.C. 13:39-5.11
Control and Monitoring of Temperature of Prescription Drugs and Chemicals; Storage Conditions; Minimum Equipment and Supplies
Authorized By: Anthony Rubinaccio, Executive Director, Board of Pharmacy.
Authority: N.J.S.A. 45:14-47 and 48.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2016-042.
Submit written comments by June 3, 2016, to:
Anthony Rubinaccio, Executive Director
Board of Pharmacy
124 Halsey Street
PO Box 45013
Newark, New Jersey 07101
The agency proposal follows:
Summary
Pharmacies are currently required to maintain all prescription drugs and chemicals under adequate storage conditions, which include proper lighting, ventilation, and temperature control as recommended by the drug manufacturer, pursuant to N.J.A.C. 13:39-5.7. The Board of Pharmacy (Board) has considered and dealt with issues associated with extended periods of power failures resulting from extreme weather conditions, such as Super Storm Sandy, severe winters, and hot summers. Because extreme temperatures can impact the effectiveness of medications, the Board is proposing a new rule and amendments to establish standards for the control and monitoring of temperature of prescription drugs and chemicals to ensure their integrity, stability, and efficacy. The Board believes the proposed new rule and amendments, which establish standards for the control and monitoring of temperature, define a temperature excursion, and specify actions that must be taken in the event of a temperature excursion, are necessary to protect public health and safety.
The Board proposes to new N.J.A.C. 13:39-5.7(b)1 to specify the storage conditions to maintain in the absence of manufacturer specifications. The Board proposes relocating the last sentence in N.J.A.C. 13:39-5.7 as the text of new subsection (b). Proposed N.J.A.C. 13:39-5.7(b)1 provides that if storage conditions are not specified by the manufacturer, the prescription drug or chemical shall be maintained according to the parameters set forth in the 2014 edition of the Drug Substance Monographs and Excipients of the United States Pharmacopeia/National Formulary (USP), which is incorporated by reference, as amended and supplemented into the rule. The Drug Substance Monographs and Excipients of the USP is available for purchase from at www.usp.org. In the absence of specific directions or limitations in the individual drug or chemical's monograph, the conditions of storage include "controlled room temperature" as defined in the USP, protection from moisture and, where necessary, protection from light. USP is the public standard-setting authority for prescription and over-the-counter products and often serves as a reference for the State boards.
To enable the control of temperature inside a refrigerator and, if applicable, a freezer, proposed new N.J.A.C. 13:39-5.8(a)8 requires pharmacies to have a refrigerator thermometer and, if applicable, a freezer thermometer. Instead of a thermometer, pharmacies may use a temperature monitoring device. Because the equipment and supplies listed under subsection (a) are intended to be used and not stored on the premises, the Board also proposes to delete "be stored, so as to" from N.J.A.C. 13:39-5.8(a).
Proposed new N.J.A.C. 13:39-5.11(a) specifies that, to ensure the integrity and stability of all prescription drugs and chemicals, they must be stored, filled, dispensed, transported, and/or delivered to the patient, agent of the patient, or facility or healthcare provider providing care to the patient at temperatures specified by the drug manufacturer. N.J.A.C. 13:39-5.11(a) further provides that if the drug manufacturer has not specified the appropriate temperature, the prescription drug or chemical shall be maintained at "controlled room temperature" as defined by USP.
Proposed new N.J.A.C. 13:39-5.11(a)1 requires a pharmacy to monitor and record the temperature of the pharmacy permitted area, refrigerator, and, if applicable, freezer, no less than twice daily with an interval of at least eight hours. Proposed new N.J.A.C. 13:39-5.11(a)1i requires pharmacies to maintain documentation of proper storage of prescription drugs and chemicals using manual, electromechanical, or electronic temperature recording equipment and/or logs. Proposed new N.J.A.C. 13:39-5.11(a)1ii requires the pharmacy to maintain documentation of the recorded temperatures for two years. Proposed new N.J.A.C. 13:39-5.11(a)1iii requires the pharmacy to calibrate the thermometers or temperature monitoring devices at predetermined intervals according to the manufacturer specifications.
Proposed new N.J.A.C. 13:39-5.11(a)2 provides that the pharmacist shall use adequate methods to ensure temperature controlled conditions are maintained during facility storage, transportation, and delivery. Pharmacists may rely on their professional judgment and the pharmacy's written policies and procedures as required in N.J.A.C. 13:39-5.11(d) to determine which methods are adequate. Proposed new N.J.A.C. 13:39-5.11(a)2i further provides that a pharmacist may reference information provided by the manufacturer, Chapter 1079 of USP, other learned treatises, or expert qualification analysis to determine the appropriate packaging material or devices to use during the shipping process. In addition, proposed new N.J.A.C. 13:39-5.11(a)2ii requires pharmacies using packaging material or devices to maintain temperature control during delivery to include instructions to the recipient concerning how to easily detect improper storage or temperature variation, and instructions on how to report the storage or temperature excursions to the pharmacy.
Proposed new N.J.A.C. 13:39-5.11(b) sets forth that the temperature in a refrigerator and, if applicable, a freezer that is used to store prescription drugs or chemicals must be maintained according to USP standards and guidelines.
Proposed new N.J.A.C. 13:39-5.11(c) specifies that the pharmacist-in-charge is responsible for ensuring proper temperature controls for all prescription drugs and chemicals in the pharmacy permitted area and that are shipped, mailed, distributed, or otherwise delivered from the pharmacy.
Proposed new N.J.A.C. 13:39-5.11(d) requires the pharmacist-in-charge to develop and maintain written policies and procedures for ensuring the proper storage of prescription drugs and chemicals in the pharmacy permitted area and during delivery from the pharmacy to the patient, agent of the patient, or the facility or healthcare provider providing care. The subsection also includes the minimum requirements for the written policies and procedures. The written policies and procedures must include a procedure for monitoring and recording the temperature of the pharmacy permitted area and refrigerator and, if applicable, freezer, and for maintaining documentation of the recorded temperatures. The written policies and procedures must include the actions to be taken in the event of a temperature excursion. Such actions must include notification to the appropriate pharmacy personnel, investigation of all temperature excursions, inspection and disposal, as applicable, of the stock in question, and corrective actions. The Board defines "temperature excursion" as any deviation from the manufacturer's specifications or, in the absence of manufacturer specifications, applicable USP standards. There must also be policies and procedures for calibrating thermometers or temperature monitoring devices. In addition, the written policies and procedures must specify the actions to be taken in the event that the prescription drugs and chemicals do not arrive at their destination in a timely manner or there is evidence that the integrity of a drug was compromised during shipment or delivery. Pharmacies are also required to train all personnel to ensure the [page=566] appropriate storage and delivery of all prescription drugs and chemicals, including refrigerated and frozen pharmaceuticals.
Proposed new N.J.A.C. 13:39-5.11(e) sets forth a Board notification requirement in the event of a temperature excursion at a permitted pharmacy practice site lasting 24 hours or more. The rule further provides that the Board must receive such notification within 48 hours of becoming aware of the temperature excursion. Proposed new N.J.A.C. 13:39-5.11(f) specifies that in the event of a temperature excursion lasting 72 hours or more, a pharmacist is precluded from dispensing any prescription drug or chemical unless the pharmacist verifies with the manufacturer that as a result of the temperature excursion the drug or chemical has not been adulterated, is safe and efficacious, and its stability has not been adversely affected.
The Board proposes new N.J.A.C. 13:39-6.2(f)9 to include as one of the responsibilities of the pharmacist-in-charge to ensure that there are written policies and procedures to ensure the proper storage and delivery of prescription drugs and chemicals consistent with the requirements of proposed N.J.A.C. 13:39-5.11, and that such policies and procedures are followed.
The Board of Pharmacy has determined that the comment period for this notice of proposal shall be 60 days. Therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this notice is excepted from the rulemaking calendar requirement.
Social Impact
The Board of Pharmacy believes the proposed new rule and amendments will have a positive impact upon the public by promoting patients' health and safety by ensuring the integrity and effectiveness of the medications they take. The Board believes that the proposed new rule and amendments will also have a positive impact on pharmacists by establishing standards for controlling and monitoring the temperature of prescription drugs and chemicals.
Economic Impact
The Board of Pharmacy believes that the proposed new rule and amendments may have an economic impact for those pharmacies using packaging material or devices to maintain temperature control during delivery of prescription drugs or chemicals from the pharmacy to patients. The cost will vary depending upon the method(s) the pharmacy chooses to use.
Pharmacies are currently required to maintain all prescription drugs and chemicals under adequate storage conditions, including temperature control. To the extent pharmacies do not have appropriate manual, electromechanical, or electronic temperature recordkeeping equipment or logs to document the proper storage of prescription drugs and chemicals, some additional costs will be incurred by those pharmacies to comply with the rules to ensure the efficacy of the drugs being dispensed to the public. Similarly, for those pharmacies that do not currently have a refrigerator thermometer and, if applicable, a freezer thermometer, or other temperature monitoring device, some additional costs will be incurred. The costs associated with the temperature recordkeeping equipment and thermometers will vary depending upon the pharmacy's choice of product(s).
The Board believes that any increased costs are outweighed by the interest in protecting public health and safety.
Federal Standards Statement
A Federal standards analysis is not required because the proposed new rule and amendments do not exceed, and in some cases reference the standards set forth in the USP, which may be viewed as establishing and setting forth Federal standards and requirements for temperature control and monitoring.
Jobs Impact
The Board does not anticipate that the proposed new rule and amendments will increase or decrease jobs in the State.
Agriculture Industry Impact
The Board does not anticipate that the proposed new rule and amendments will have any impact on the agriculture industry in the State.
Regulatory Flexibility Analysis
Currently, the Board licenses approximately 16,600 pharmacists and 2,200 pharmacies. If Board licensees and permit holders are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.
The proposed new rule and amendments impose reporting, recordkeeping, and compliance requirements on Board licensees and permit holders. These requirements are discussed in the Summary above.
No additional professional services will be needed to comply with the proposed new rule and amendments. The costs of compliance with the proposed new rule and amendments are discussed in the Economic Impact statement above. The Board believes that the proposed new rule and amendments should be uniformly applied to all licensees and permit holders in order to ensure public health and safety. Therefore, no differing reporting, recordkeeping, or compliance requirements for any licensees or permit holders are provided based on the size of the business.
Housing Affordability Impact Analysis
The proposed new rule and amendments will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the proposed rule and amendments concern the control and monitoring of temperature of prescription drugs and chemicals.
Smart Growth Development Impact Analysis
The proposed new rule and amendments will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed new rule and amendments concern the control and monitoring of temperature of prescription drugs and chemicals.
Full text of the proposal follows (additions indicated in boldface
thus; deletions indicated in brackets [thus]):
SUBCHAPTER 5. RETAIL FACILITY REQUIREMENTS
13:39-5.7 Adequate storage
(a) There shall be sufficient shelf, drawer, or cabinet space within
the prescription area for the proper storage of prescription drugs and chemicals and the minimum equipment required pursuant to N.J.A.C. 13:39-5.8.
(b) All prescription drugs and chemicals shall be maintained under adequate storage conditions, including proper lighting, ventilation, and temperature control, as recommended by the drug manufacturer.
1. If storage conditions are not specified by the drug manufacturer, the prescription drug or chemical shall be maintained according to the parameters set forth in the Drug Substance Monographs and Excipients of the United States Pharmacopeia/National Formulary, 2014 edition, incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia/National Formulary website
atwww.usp.org.Where no specific directions or limitations are provided in the packaging and storage section of individual monographs or in the manufacturer specifications, the conditions of storage shall include storage at controlled room temperature, protection from moisture and, where necessary, protection from light. "Controlled room temperature" is as defined in the USP.
13:39-5.8 Minimum equipment and supplies; cleanliness
(a) All prescription areas shall contain the following minimum equipment and supplies, which shall [be stored, so as to] be readily accessible:
1.-7. (No change.)
8. Refrigerator thermometer and, if applicable, freezer thermometer, or temperature monitoring device to enable control of temperature;
Recodify existing 8.-13. as
9.-14. (No change in text.)
(b)-(c) (No change.)
[page=567] 13:39-5.11 [(Reserved)]
Control and monitoring of temperature of prescription drugs and chemicals
(a) All prescription drugs and chemicals shall be stored, filled, dispensed, transported, and/or delivered to the patient, agent of the patient, or facility or healthcare provider providing care to the patient to assure and maintain the integrity and stability of the prescription drug or chemical at temperatures as specified by the drug manufacturer. If the drug manufacturer has not specified the appropriate temperature, the prescription drug or chemical shall be maintained at "controlled room temperature," as defined in the United States Pharmacopeia/National Formulary (USP), 2014 edition, incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia/National Formulary website atwww.usp.org.
1. A pharmacy shall monitor and record the temperature of the pharmacy permitted area and refrigerator and, if applicable, freezer, no less than twice daily with an interval of at least eight hours.
i. Appropriate manual, electromechanical, or electronic temperature recording equipment and/or logs shall be utilized to document proper storage of prescription drugs and chemicals.
ii. A pharmacy shall maintain documentation of the recorded temperatures for two years.
iii. A pharmacy shall calibrate thermometers or temperature monitoring devices at predetermined intervals according to the manufacturer specifications.
2. A pharmacy that delivers a filled prescription drug or chemical to the patient, agent of the patient, or facility or healthcare provider providing care to the patient by any method, except when picked up directly from the pharmacy by the patient or his or her authorized agent, shall, in the professional judgment of the pharmacist, and in accordance with the pharmacy's policies and procedures as set forth in (d) below, use adequate methods to ensure temperature controlled conditions are maintained during facility storage, transportation, and delivery.
i. To ensure that temperature control is maintained during delivery, the shipping processes may include the use of appropriate packaging material or devices according to information provided by the manufacturer, Chapter 1079 of USP, other learned treatises, or expert qualification analysis.
ii. When packaging material or devices are used to maintain temperature control during delivery, the contents of the package shall include instructions to the recipient how to easily detect improper storage or temperature variation, and instructions how to report the storage or temperature excursion to the pharmacy.
(b) The temperature in a refrigerator and, if applicable, freezer that are used to store prescription drugs or chemicals must be maintained according to USP standards and guidelines.
(c) The pharmacist-in-charge is responsible for ensuring proper temperature controls for all prescription drugs and chemicals in the pharmacy permitted area and all prescription drugs and chemicals that are shipped, mailed, distributed, or otherwise delivered from the pharmacy.
(d) The pharmacist-in-charge shall develop and maintain written policies and procedures to ensure the proper storage in the pharmacy permitted area of all prescription drugs and chemicals, and the proper storage when prescription drugs or chemicals are delivered from the pharmacy to the patient, agent of the patient, or facility or healthcare provider providing care. The written policies and procedures shall include, at a minimum, the following:
1. Monitoring and recording the temperature of the pharmacy permitted area and refrigerator and, if applicable, freezer consistent with the requirements of this section;
2. Maintaining documentation of the recorded temperatures consistent with the requirements of this section;
3. Actions to be taken in the event of temperature excursions include, but are not limited to: notification of appropriate personnel, investigation of all temperature excursions, inspection and disposal, as applicable, of the stock in question, and corrective actions;
i. For purposes of this paragraph, a "temperature excursion" means any deviation from the manufacturer's specifications or, in the absence of manufacturer specifications, applicable USP standards.
4. Calibrating thermometers or temperature monitoring devices consistent with the requirements of this section;
5. Actions to be taken in the event that the prescription drugs and chemicals do not arrive at their destination in a timely manner or when there is evidence that the integrity of a drug was compromised during shipment or delivery; and
6. Training of all personnel to ensure the appropriate storage and delivery of all prescription drugs and chemicals, including refrigerated and frozen pharmaceuticals.
(e) In the event of a temperature excursion, as defined in (d)3i above, at a permitted pharmacy practice site lasting 24 hours or more, the pharmacist-in-charge shall immediately notify the Board. Notification shall be made in a manner such that notice is received by the Board within 48 hours of becoming aware of the temperature excursion.
(f) In the event of a temperature excursion, as defined in (d)3i above, lasting 72 hours or more, a pharmacist shall not dispense any prescription drug or chemical unless the pharmacist verifies with the manufacturer of the prescription drug or chemical that as a result of the temperature excursion, the drug or chemical has not been adulterated, is safe and efficacious, and its stability has not been adversely affected.
SUBCHAPTER 6. PHARMACIST-IN-CHARGE; PHARMACY PERSONNEL
13:39-6.2 Pharmacist-in-charge
(a)-(e) (No change.)
(f) A pharmacist-in-charge shall be a full-time employee, employed for a minimum of 35 hours per week and shall be physically present in the pharmacy or pharmacy department for that amount of time necessary to supervise and ensure that:
1.-7. (No change.)
8. The prescription area is maintained in an orderly and sanitary manner; [and]
9. There are written policies and procedures to ensure the proper storage and delivery of all prescription drugs and chemicals consistent with the requirements set forth in N.J.A.C. 13:39-5.11 and that such policies and procedures are followed; and
[9.]
10. (No change in text.) |
