gateway - New Jersey Division of Consumer Affairs

1 PLEASE READ Rules and regulations of the Division of Consumer Affairs , the boards and committees in, and other units of, the Division are codified in Title 13 of the New Jersey Administrative Code, published by LexisNexis. Notices of proposal and notices of adoption are printed in the New Jersey Register, also published by LexisNexis. The official text of the rules and regulations and their regulatory history and notices of rule proposals and adoptions can be found through the free LexisNexis Public Access Portal. LexisNexis Public Access Portal: The text of rules and regulations and notices of proposal and adoptions in PDF format provided on this website by the Division of Consumer Affairs are unofficial courtesy copies, which may differ from the official text. Though every effort is made to ensure that the text of courtesy copies is identical to the official version, if any discrepancies exist between the text on this website and the official version, the official version will govern.

2 STATE board OF pharmacy LAW AND PUBLIC SAFETY chapter 39 Page 1 of 174 Last Revision Date: 05/21/2018 NEW Jersey ADMINISTRATIVE CODE TITLE 13 LAW AND PUBLIC SAFETY chapter 39 STATE board OF pharmacy STATE board OF pharmacy LAW AND PUBLIC SAFETY chapter 39 Page 2 of 174 Last Revision Date: 05/21/2018 chapter TABLE OF CONTENTS SUBCHAPTER 1. GENERAL PROVISIONS .. 8 13:39 Purpose and 8 13:39 Definitions .. 9 13:39 Fee schedule .. 12 13:39 Payment of penalties .. 15 13:39 Opportunity to be heard .. 15 13:39 Waiver .. 15 13:39 Failure to complete application process .. 16 13:39 Compliance with policy and procedures .. 16 SUBCHAPTER 2. REQUIREMENTS FOR INITIAL LICENSURE .. 16 13:39 Requirements for initial licensure as a pharmacist .. 16 13:39 Licensure examination scores .. 18 13:39 Proof of character .. 18 13:39 Criminal history background check .. 19 13:39 Refusal to license.

3 19 13:39 Internship and externship practical experience requirements .. 19 13:39 pharmacy intern registration requirements .. 22 13:39 (Reserved) .. 23 13:39 (Reserved) .. 23 13:39 (Reserved) .. 23 13:39 (Reserved) .. 23 13:39 (Reserved) .. 23 13:39 (Reserved) .. 23 13:39 (Reserved) .. 23 13:39 (Reserved) .. 23 13:39 (Reserved) .. 23 13:39 (Reserved) .. 23 13:39 (Reserved) .. 23 13:39 (Reserved) .. 24 13:39 (Reserved) .. 24 SUBCHAPTER 2A. REQUIREMENTS FOR RECIPROCAL LICENSURE .. 24 13:39 Requirements for reciprocal licensure .. 24 13:39 Proof of character .. 26 13:39 Refusal to license .. 27 STATE board OF pharmacy LAW AND PUBLIC SAFETY chapter 39 Page 3 of 174 Last Revision Date: 05/21/2018 13:39 Criminal history background check .. 27 13:39 Multistate pharmacy Jurisprudence Examination .. 27 SUBCHAPTER 3. PHARMACIST REQUIREMENTS .. 27 13:39 Authorization to practice; display of license.

4 27 13:39 Replacement license .. 28 13:39 Change of name .. 28 13:39 Change of address of record; service of process .. 28 13:39 Verification of licensure .. 28 13:39 Reproduction of license prohibited .. 29 13:39 License renewal .. 29 13:39 License reactivation .. 30 13:39 License reinstatement from administrative and disciplinary license suspensions .. 31 13:39 Steering prohibited .. 33 13:39 Responsibilities of pharmacists .. 33 SUBCHAPTER 3A. CONTINUING EDUCATION .. 34 13:39 Continuing education credit hour requirements .. 34 13:39 Criteria for continuing education credit .. 34 13:39 Continuing education credit hour calculations .. 35 13:39 Continuing education credit hour reporting procedure .. 36 13:39 Waiver of continuing education requirements .. 37 13:39 Responsibilities of continuing education sponsors .. 38 13:39 Monitoring of continuing education programs or courses.

5 39 SUBCHAPTER 4. pharmacy PERMIT REQUIREMENTS .. 39 13:39 New pharmacies; pharmacy departments; eligibility and application .. 39 13:39 Issuance of permits; permit renewals .. 41 13:39 Display of permits .. 41 13:39 Death of owner or partner .. 41 13:39 Change of ownership; asset acquisition .. 42 13:39 (Reserved) .. 43 13:39 Change of location and/or address of licensed premises .. 43 13:39 Remodeling of licensed premises .. 43 13:39 Change of name .. 44 13:39 Discontinued pharmacies .. 44 13:39 Availability of records upon termination of business or change of ownership .. 45 13:39 Business hours; unauthorized closing .. 45 13:39 Replacement permit .. 46 13:39 Reproduction of permits .. 46 STATE board OF pharmacy LAW AND PUBLIC SAFETY chapter 39 Page 4 of 174 Last Revision Date: 05/21/2018 13:39 Security of pharmacies and pharmacy departments .. 46 13:39 Permits; specialized permits.

6 49 13:39 Steering prohibited .. 49 13:39 Responsibilities of permit holders .. 49 13:39 Procedures for centralized prescription handling .. 49 13:39 Out of State pharmacy registration .. 53 13:39 Procedures for physician ordered or government sponsored immunizations performed by pharmacists .. 56 13:39 Requirements for pharmacists to administer influenza vaccine to patients under 18 years of age .. 61 SUBCHAPTER 5. RETAIL FACILITY REQUIREMENTS .. 62 13:39 Purpose and 62 13:39 pharmacy access and egress .. 62 13:39 pharmacy signs .. 62 13:39 Spatial requirement of pharmacy prescription area .. 62 13:39 Prescription counter .. 63 13:39 Prescription area sink .. 63 13:39 Adequate storage .. 63 13:39 Minimum equipment and supplies; cleanliness .. 64 13:39 Prescription balances, scales, weights and automatic counting device .. 65 13:39 Restriction on storage of prescription legend drugs and controlled dangerous substances.

7 66 13:39 Control and monitoring of temperature of prescription drugs and chemicals .. 66 13:39 (Reserved) .. 69 13:39 Prescription drug retail price list .. 69 SUBCHAPTER 6. PHARMACIST IN CHARGE; pharmacy PERSONNEL .. 69 13:39 Purpose and 69 13:39 Pharmacist in charge .. 69 13:39 Identification 71 13:39 Meal or restroom breaks .. 71 13:39 Prescription handling by pharmacy externs, pharmacy interns, pharmacy technicians, pharmacy technician applicants, or unlicensed or unregistered personnel .. 72 13:39 pharmacy technician registration and pharmacy technician applicants .. 73 13:39 Authorization to practice as a pharmacy technician; display of registration .. 74 13:39 Replacement of technician registration .. 75 13:39 Technician change of name .. 75 13:39 Technician change of address of record; service of process .. 75 13:39 Verification of technician registration .. 76 13:39 Reproduction of technician registration prohibited.

8 76 STATE board OF pharmacy LAW AND PUBLIC SAFETY chapter 39 Page 5 of 174 Last Revision Date: 05/21/2018 13:39 pharmacy technician registration renewal .. 76 13:39 pharmacy technician registration reactivation .. 77 13:39 pharmacy technician registration reinstatement from administrative and disciplinary suspensions .. 78 13:39 pharmacy technician duties and pharmacist technician ratios .. 80 SUBCHAPTER 7. DRUG DISPENSING AND PRESCRIPTION RECORDS .. 84 13:39 Valid prescriptions .. 84 13:39 Lack of information on original prescription .. 84 13:39 Authorization for renewal of prescriptions; new prescriptions .. 85 13:39 Emergency dispensing .. 85 13:39 Approval of FDA necessary .. 86 13:39 Required records and documents .. 86 13:39 Copies of prescriptions and/or patient profile .. 88 13:39 Transfer of prescriptions between pharmacies .. 88 13:39 Filing and storage of controlled substance prescriptions.

9 90 13:39 Prescriptions transmitted by facsimile .. 90 13:39 Electronically transmitted prescriptions .. 92 13:39 Labeling .. 94 13:39 Professional judgment in dispensing drugs .. 95 13:39 Advertising and sale of prescription drugs .. 95 13:39 Restriction on sale of Schedule V over the counter controlled substances .. 96 13:39 Return of prescription medication .. 98 13:39 Disposal of unwanted drugs .. 99 13:39 Outdated drugs or drugs marked "sample" .. 99 13:39 Patient profile record system .. 99 13:39 Drug utilization review .. 101 13:39 Patient counseling .. 101 13:39 Accurate processing and dispensing .. 102 13:39 Biological products .. 103 SUBCHAPTER 8. (RESERVED) .. 104 SUBCHAPTER 9. PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES .. 104 13:39 Purpose and 104 13:39 Definitions .. 104 13:39 Licensure of institutional pharmacies .. 106 13:39 Contract pharmaceutical services; institutional permit required.

10 106 13:39 Advisory committees .. 106 13:39 pharmacy and Therapeutics Committee; applicability; policies and procedures .. 106 STATE board OF pharmacy LAW AND PUBLIC SAFETY chapter 39 Page 6 of 174 Last Revision Date: 05/21/2018 13:39 (Reserved) .. 107 13:39 Control of health care pharmaceutical services; responsibilities of the pharmacist in charge of the provider pharmacy .. 107 13:39 (Reserved) .. 107 13:39 Pharmaceuticals; drug supply; investigational drugs; controlled dangerous substances .. 107 13:39 Drug disbursement; written orders .. 108 13:39 Drug disbursement; oral orders .. 108 13:39 Monitoring of patient drug therapy .. 109 13:39 Medication not dispensed in finished form .. 109 13:39 Drug labeling .. 110 13:39 Use of patient's own medication .. 110 13:39 Drug dispensing devices .. 110 13:39 Disposal of unused medications .. 111 13:39 Records and reports .. 112 13:39 Drug information and education.