1 May 2010 Rhonda Dash, MPH Director, Research Compliance
2 Introduce the new Director of Research Compliance Review Applicable Federal Regulations Review Applicable State Regulations Review UNTHSC new Policies and Procedures for Controlled Substance in Research
3 I provide oversight for research compliance. My focus is to ensure that research at UNTHSC is performed in accordance with strict ethical standards, in compliance with federal and state regulations, and institutional policies. My goal is to help protect the research subject, the research data, the researcher & their staff, and the institution. I strive to meet this goal primarily through audits and education. I am committed to the highest standards of quality and integrity in all areas of research. REMEMBER I are not out to get you and I am not the police. I am on your side!
4 Internal Audit No dated 2009 A comprehensive uniformed program Access to controlled substance is not limited Records are not complete and accurate Outdated substances have not been disposed of in the last ten years
5 Drug Enforcement Administration Office of Diversion Control Controlled Substance Act May 1971 Closed system for distribution Trace: manufacture dispensed ultimate user Registration Reduced Diversion CFR Title 21 Part Divided into five (5) schedules Schedules II-V have an accepted medical use in the US
6 Texas Department of Public Safety Texas Controlled Substances Act 1973 Controlled Substances Registration Program Health and Safety Code, Title 6. Food, Drugs, Alcohol, and Hazardous Substances, Subtitle C. Substance Abuse Regulation and Crimes, Chapter 481. Texas Controlled Substance Act (HSC Title 6, Subtitle C, Chapter 481) TAC Title 37, Part I, Chapter 13
7 CSA Sec. 822 Persons Required to Register the term practitioner is defined as a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital,.in which the practitioner practices or performs research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research. Every person or entity that handles controlled substances must be registered with DEA or be exempt by regulation from registration.
8 It is the responsibility of each individual Principal Investigator to obtain appropriate license and registration. Shall not allow license and registration to lapse until all controlled substances are spent or disposed Submit a copy of each license to the Director of Research Compliance, CBH 333 Remainders Identify
11 Each PI must notify the DEA and TXDPS before the seventh day after any changes in name, address, telephone, schedules, or any information required on the application, registration, or permit (TAC ).
12 No individual who has been convicted of a felony for any State or Federal law regarding controlled substances should be allowed access to controlled substances (21CFR ).
13 Controlled substances must be ordered on-line using UNTHSC procurement system (EPro). Miller Veterinary Supply Co, Inc ( ) Butler Schein Animal Health ( ) Stocks of controlled substances must be kept to the smallest quantity needed. Category Code =
14 Factors 1. Type of activity (Processing, packaging, labeling) 2. Type & form of controlled substances (Bulk liquids, dosage units, nonusable powders) 3. Location 4. Type of building 5. Type of vault, safe, secure enclosures, or storage system 6. Type of closure (Built-in combination locks, key locks, padlocks, self closing ) 7. Key and lock control (Adequacy, accountability, routine changing, issuance and control procedures, logging, combination security ) 8. alarm systems (Adequacy supervision, method of signal transmission, maintenance and testing, signal & response time) 9. Public access / perimeter fencing 10. Supervision of employees (Access control, control of & accountability identification, responsibilities) 11. Guest / visitor procedures 12. Local police / security force (availability, legal obligation to respond, frequency of patrol, size of force, alarm response time, training) 13. Adequacy of internal systems for monitoring controlled substances (storage security, common or contract carrier security ) 14. The quantity of controlled substances handled
15 All Principal Investigators authorized to use controlled substances are responsible for establishing and maintaining effective controls and procedures against unauthorized access to controlled substances. All controlled substances shall be stored in a substantially constructed, securely locked, cabinet (safe) as per Federal regulations. The cabinet should be permanently constructed or attached to a building structure to prevent physical removal. Access to locked rooms and locked storage cabinets containing controlled substances shall be restricted to limited authorized personnel. 21 CFR ;
16 All controlled substances shall be kept locked in their storage location except for the actual time required for authorized staff to remove, legitimately work with, and replace them. The storage and handling of controlled substances must adhere to all applicable state and federal laws. 21 CFR ;
17 All controlled substance shipments must be processed and stored in a security cabinet as soon as possible after receipt. Open the package and verify the contents. All inventories should be entered into the Scheduled Drug Inventory log book. This book is available from the Director of Research Compliance. Schedule I and II compounds shall be stored different from Schedule III-V substances, in a lockable room separate from the laboratories. 21 CFR ;
18 There shall be a limited number of authorized personnel which have keys and / or combination codes to operate locking devices. Principal Investigators shall rekey a key lock if a key is lost or upon termination of an employee having possession of a key. Principal Investigators shall change a combination lock code if a record of the combination is lost or stolen or upon termination of an employee having knowledge of the combination. TAC
19 Bulk controlled substance in solid or pure form shall not be removed from the lockable room with the safe at any time. At least two authorized persons shall co-sign for initial storage of a sealed vial of bulk compound and subsequent laboratory use. I am available to assist in evaluating and making recommendations regarding site security.
20 All containers of controlled substances must be properly labeled. If the laboratory re-packages, compounds or dilutes controlled substances, appropriately label the re-packaged, compounded or diluted substance and store it in the safe. The label on diluted or combined controlled substances that will be stored at least overnight in the safe must include the following information: Name of controlled substance Final concentration of controlled substance Volume per container Expiration date no more than 30 days after dilution
21 A researcher may dispose of out-of-date, damaged, or otherwise unusable or unwanted controlled substances by transferring them to a registrant who is authorized to receive such materials. These registrants are referred to as "Reverse Distributors. Schedule I and II controlled substances should be transferred via the DEA Form 222, while Schedule III V compounds may be transferred via invoice. The registrant should maintain copies of the records documenting the transfer and disposal of controlled substances for a period of two years.
22 Expired or unused product(s) must be labeled, separated, and stored under lock and key until ready for disposal. You should contact the Office of Research Compliance, Ext # 2458, to request disposal of controlled substances. You must provide a copy of your DEA license for disposal.
23 Disposal of controlled substances will be documented in the spiral bound binder labeled as Scheduled Drug Inventory Record Year All additional records documenting disposal must also be maintained.
24 Drug accountability records shall be completed upon receipt of controlled substances, after each use, disposal, or loss. PIs must maintain complete and accurate inventory records for all controlled substances. Records shall be kept separately from all other records, in or near the primary work area, and be available for inspection. All records shall be maintained for at least two years from the date of the last recorded transaction.
25 Receipt of Controlled Substance: Each receiving record must be verified, signed, and dated upon receipt by the authorized person receiving the controlled substance (21 CFR ). Use of Controlled Substance: A separate and current record for the use of each controlled substance, indicating the name of substance, strength, date dispensed, dispensed to whom, laboratory building/room, reason for, total balance on hand, amount used, authorized user s signature, and authorized witness s signature must be documented in the Scheduled Drug Inventory Record Year spiral bonded log book (21 CFR ).
29 Initial Inventory When issued a DEA registration, a registrant shall take an initial inventory, which is an actual physical count of all controlled substances in their possession. **The registrant should make a record showing a zero inventory upon receipt of license. Inventory means a complete and accurate list of all stocks and forms of controlled substances in the possession of the registrant as determined by an actual physical count.
30 After an initial inventory is taken, the registrant shall take a new inventory of all controlled substances on hand at least every two years. Record must state Biennial Inventory The inventory of Schedule II controlled substances must be kept separate from those for all other controlled substances.
31 If the substance is listed in Schedule II, make an exact count or measure of the contents, or If substance is listed in Schedule III-V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules then make exact count of the contents
32 Disposal of Controlled Substance (III-V) via authorized Reverse Distributor: Current record indicating the number of commercial containers, quantity per container, date of disposal, how disposed, name, address, and registration number of person to whom distributed (21 CFR ). Inventory of Controlled Substance: A complete and accurate inventory of the stock of controlled substances within each authorized registrant s laboratory must be performed initially upon receipt of DEA license. ** You must record zero inventories at this time on the Research Control Substance Biennial Inventory Record. The authorized person conducting the inventory and authorized witness must also sign the Research Control Substance Bi-Annual Inventory Record (21 CFR ).
34 BiennialInventory: After the initial inventory is taken, a new inventory of all stocks of controlled substances on hand should be conducted every two years. The inventory date and opening or close of business, drug name, strength, quantity, drug form (tablet, capsule, etc), number of units/volume, total quantity, expiration date, name of Principal Investigator, and location must be recorded on the Research Control Substance Biennial Inventory Record at this time. The authorized person conducting the inventory and authorized witness must also sign the Research Control Substance Biennial Inventory Record (21 CFR ).
35 Authorized Users Signature Log as designated by PI: date signed, printed name, title, signature, initials, and date departed.
37 Registrant shall notify the local DEA office, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft DEA Form 106
38 Factors of Significant Loss of any controlled substances Actual quantity lost in relation to type of business Specific Whether associated with access to controlled substances by specific individual(s) or whether loss can be attributed to unique activities that may take place involving controlled substances Pattern of losses over a specific time period, whether losses appear random, & results of efforts taken to resolve the losses Whether specific controlled substances are likely candidates for diversion Local trends and other indicators of the diversion potential of the missing controlled substance
39 Must notify in writing of: Discrepancy in amount of an item ordered and the amount received, if not back ordered Loss of theft during shipment from a source Loss or theft from current inventory DPS Form NAR-91 Copy of DEA Form 106
40 Authorized personnel must be alert and attentive to the disappearance of any controlled substances. Thefts, suspected thefts, unauthorized uses, or any significant loss of controlled substances must be immediately reported (within the next business day) to the Office of Research via the Director of Research Compliance and the University Police upon the discovery of the loss. In addition, the DEA requires that theft or significant loss of controlled substances be reported on DEA Form 106 Report of Theft or Loss of Controlled Substances. The form is available at
41 The TXDPS requires notification via DPS Form NAR-91 of the following: (1) Discrepancy in amount of an item ordered and the amount received, if not back ordered; (2) Loss of theft during shipment from a source; and (3) Loss or theft from current inventory. If a container of a controlled substance is inadvertently broken or damaged, document this on the disposition record and have an authorized witness sign and date it. Complete a DEA Form 41 for the amount of the substance lost and write "unintentional destruction" on the form. This form is available at Signatures of the authorized person who broke the bottle, the authorized witness and the Registrant are required on Form 41. Mail the original to the DEA and file a copy with your controlled substance records.
42 Reports of drug diversion by fellow employees is not only a necessary part of an overall employee security program but also serves the public interest at large. It is, therefore, the position of DEA that an employee who has knowledge of drug diversion from his employer by a fellow employee has an obligation to report such information to a responsible security official of the employer. The employer shall treat such information as confidential and shall take all reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing information.
43 An employee who has knowledge of a drug diversion associated with the actions of a fellow employee, supervisor, or Principal Investigator has an obligation to report such information to the Office of Research or the EthicsLine at You may also report on-line at The Texas Whistleblower Act protects anyone who, in good faith, reports unlawful activity from retaliation for making such a report.
44 Schedule II Schedule III & IV Schedule V Registration Required Required Required Ordering Receiving Records Daily Use Inventory Security Theft or Significant Loss UNTHSC Epro (Miller Vet Butler Schein) Order Forms (DEA Form-222) Sign and Date Spiral Bound Logbook Initially Update Every 2 Yrs Locked Drawer or Safe Report and complete DEA Form 106 UNTHSC EPro (Miller Vet Butler Schein) Invoice Sign and Date Spiral Bound Logbook Initially Update Every 2 Yrs Locked Drawer or Safe Report and complete DEA Form 106 UNTHSC EPro (Miller Vet Butler Schein) Invoice Sign and Date Spiral Bound Logbook Initially Update Every 2 Yrs Locked Drawer or Safe Report and complete DEA Form 106 Disposal Reverse Distributor Reverse Distributor Reverse Distributor
45 Annually Updates for chemicals and schedules
46 1. State / Federal Sanctions Loss of License and Registration Prison Fines ( Documentation discrepancies up to $10K ) 2. Disciplinary action per UNTHSC Faculty Handbook 3. Media 4. Career
47 Audit, Monitor, and Report (Details/Specifics) Training and Education Polices and Procedures Compliance Roles and Responsibilities Key Point: Policies, procedures, and practices must be aligned!
48 RHONDA DASH, MPH, CHRC DIRECTOR OF RESEARCH COMPLIANCE CBH
ARKANSAS STATE UNIVERSITY GOVERNING PRINCIPLES FOR THE USE OF CONTROLLED SUBSTANCES IN RESEARCH 1.0 INTRODUCTION Arkansas State University (ASU) is committed to enhancing the growth of research and other
University of Pittsburgh Guidelines for the Ordering and Use of Prescription Drugs and Devices and Controlled Substances for Non- Clinical Laboratory Research Definitions: 1. Authorized Agent(s) of the
Controlled Substance Policy for Research The University of North Carolina at Greensboro Approved 7/1/2013 I. Purpose University researchers may, in the course of lawful research, teaching or testing, find
2015 Controlled Substance Policy and Procedures NORTHERN ILLINOIS UNIVERSITY OFFICE OF RESEARCH COMPLIANCE AND INTEGRITY Contents A. Controlled Substance Policy... 4 1. Background, Purpose, and Scope...
UCSD Controlled Substances Program Procedures I. PROCEDURE A. Controlled Substance Use Authorization Requirements A Controlled Substance Use Authorization (CSUA) must be completed prior to acquiring controlled
USE OF CONTROLLED SUBSTANCES AN OVERVIEW FOR RESEARCHERS APPLICABILITY (WITH REGARD TO CONTROLLED SUBSTANCES) This presentation is applicable to: Animal and non-animal research This presentation is mostly
ARKANSAS PRODUCTS: Any product containing ephedrine, pseudoephedrine, or phenylpropanolamine or any of their salts, isomers, or salts of isomers, alone or in a mixture. (A.C.A. 5-64-212) PRODUCT EXEMPTIONS:
Yale University Policy on the Use of Controlled Substances in Research Revised October 2009 Prepared for the University Safety Committee by the Offices of the Vice President and General Counsel and Environmental
Use of Controlled Substances In Research Manual August 2015 This manual and all forms are posted online at: http://www.research.vcu.edu/controlled_substances/cs_manual.pdf Questions about the information
NH Laws / Rules Regarding Limited Retail Drug Distributors 318:1, VII-a. "Limited retail drug distributor'' means a distributor of legend devices or medical gases delivered directly to the consumer pursuant
MISSOURI PRODUCTS: All products (single entity & combination) containing any detectible quantity of PSE PPA, or EPH. (V.A.M.S. 195.017) PRODUCT EXEMPTIONS: All products dispensed upon prescription exempt
: I. PURPOSE The purpose of this policy is to establish procedures for the proper control, storage, use and handling of investigational drugs and biologics to ensure that adequate safeguards are in place
HOSPITAL NAME INSTITUTIONAL POLICY AND PROCEDURE (IPP) Department: Manual: Section: TITLE/DESCRIPTION POLICY NUMBER NARCOTICS AND CONTROLLED DRUGS EFFECTIVE DATE REVIEW DUE REPLACES NUMBER NO. OF PAGES
Attaining Proper DEA Licensing and Maintenance of Controlled Substances in Researcher Laboratories Much of this material was taken from the EHS Laboratory Safety Manual, Chapter 9 Index Summary for acquiring
D. E. A. Rules 21 C.F.R. 1300 Everything that you need to know but were afraid to ask DEA Rules - Objectives The student will be able to discuss the manner in which the DEA regulates the distribution of
Wayne State University Office of Environmental Health & Safety Controlled Substances Program Why is Wayne State doing this? In 2011, a survey of our laboratories revealed that some were not adhering to
File No: Controlled Substances Orig. Date: 04/8/2013 Revision Date: Marquette University Controlled Substances Policy and Procedure Policy: It is the policy of Marquette University to properly license,
3341-7-09 Use of Controlled Substances in Research. Applicability Faculty and staff who hold federal Drug Enforcement Administration (DEA) licenses to use controlled substances for research purposes. Responsible
STANDARD OERATING ROCEDURE #401 CONTROLLED SUBSTANCES 1. UROSE This Standard Operating rocedure (SO) describes procedures for acquiring, storing, using and discarding controlled substances. 2. RESONSIBILITY
CHAPTER 61-03-02 CONSULTING PHARMACIST REGULATIONS FOR LONG-TERM CARE FACILITIES (SKILLED, INTERMEDIATE, AND BASIC CARE) Section 61-03-02-01 Definitions 61-03-02-02 Absence of Provider or Consulting Pharmacist
Using Controlled Substances in Research, Teaching, and Veterinary Care at UAB I. The DEA and Controlled Substances II. The Federal Drug Enforcement Administration (DEA) is authorized to prevent, detect,
UTCVM PHARMACY STANDARD OPERATING PROCEDURES Updated: 4/5/2004 I. General Procedures A. Hours: The Pharmacy will be open Monday through Friday, 8:00AM to 6:00PM; Saturday 8:00AM to 1:00PM. The Pharmacy
Nurse-Managed Medication Inventory Information for Employers College of Registered Nurses of British Columbia 2855 Arbutus Street Vancouver, BC Canada V6J 3Y8 T: 604.736.7331 F: 604.738.2272 Toll-free:
ARKANSAS Downloaded January 2011 302 GENERAL ADMINISTRATION 302.11 Pharmacies operated in nursing homes shall be operated in compliance with Arkansas laws and shall be subject to inspection by personnel
BOARD OF PHARMACY DIVISION 41 OPERATION OF PHARMACIES (RETAIL AND INSTITUTIONAL DRUG OUTLETS) CONSULTING PHARMACISTS AND OPERATION OF DRUG ROOMS 855-041-6050 Definitions Hospitals with Pharmacies (1) In
Chapter 17. Institutional Pharmacy Louisiana Administrative Code Title 46 Professional and Occupational Standards Subchapter A. General Requirements Part LIII: Pharmacists 1701. Cross References A. For
Page: 1 of 7 EADS-NA Code of Ethics Introduction The Company demands high ethical standards of conduct from its directors, employees, and agents and will conduct its business with honesty, integrity, and
CONTROLLED SUBSTANCES PROGRAM MANUAL UNIVERSITY OF CALIFORNIA, SAN FRANCISCO OFFICE OF ENVIRONMENT, HEALTH AND SAFETY Renewed: October 2011 50 Medical Center Way San Francisco, CA 94143-0942 tel: 415/476-1300
45 Bee Street MSC 206 Charleston SC 29425-2060 Director 843 792 1316 Adm. Office 843 792-4561 Fax 843 792 1204 www.musc.edu Controlled Substance Registration Process and Record Keeping IMPORTANT INFORMATION
HOSPITAL NAME INSTITUTIONAL POLICY AND PROCEDURE (IPP) Department: Manual: Section: TITLE/DESCRIPTION POLICY NUMBER MEDICATIONS EFFECTIVE DATE REVIEW DUE REPLACES NUMBER NO. OF PAGES APPROVED BY APPLIES
Outline of DEA Rules for Controlled Substance Disposal Programs Published December 21, 2012, 77 Fed. Reg. 75784 Comments Due: February 19, 2013 1. What methods of disposing medications, including Schedule
Patient Safety Road Map to Controlled Substance Diversion Prevention Road Map to Diversion Prevention safe S Safety Teams/ Organizational Structure A Access to information/ Accurate Reporting/ Monitoring/
18.104.22.168 PUBLIC HEALTH CLINICS: A. CLINIC LICENSURE: (1) All clinics where dangerous drugs are administered, distributed or dispensed shall obtain a limited drug permit as described in Section 61-11-14
Michael D. Bullek BSP Rph. Commissioner, New Hampshire Board of Pharmacy Legislative changes PDMP program changes 503B outsourcing facilities Rules changes Ph800 review Ph300 Ph400 Ph700 Current issues
UNIVERSITY OF WASHINGTON SCHOOL OF DENTISTRY Subject: UW School of Dentistry Comprehensive Medication Policy Policy Number: Effective Date: December 2014 Revision Dates: June 2015 PURPOSE This policy provides
Oregon Trail School District 46 Code: JHCD-AR(1) Adopted: 9/14/98 Readopted: 4/12/04 Orig. Code(s): JHCD-AR Administering Noninjectable Medicines to Students** Students may, subject to the provisions of
Eight Important Principles For Managing Prescription Medications In the Athletic Training Room Robert Nickell, RPh, FAPO, FCPHA, FACA Sports Pharmacist USA Team Pharmacist President and CEO, Sportpharm
Policy 6.007. ADMINISTRATION OF MEDICATIONS POLICY It is the policy of Cooperative Educational Services (C.E.S.) that students who require any medications to be administered during school hours, including
Custodial Procedures Manual Table of Contents Page 1. Drug Policies and Procedures 1 A. Procurement of Prescription Drugs 1 i. Prescription drugs may only be accepted from 1 pharmacies and or practitioners.
MANUAFACTURERS AND WHOLESALERS CHAPTER 1140-9 (Rule 1140-9-.05, continued) RULES OF THE TENNESSEE BOARD OF PHARMACY Formatted CHAPTER 1140-9 MANUFACTURERS AND WHOLESALERS/DISTRIBUTORS TABLE OF CONTENTS
Introduction The following procedure describes the instructions to ensure that Indiana University research is in compliance with both State and Federal regulations concerning the use and handling of controlled
Mail To: P.O. Box 8935 Ship To: 1400 E. Washington Avenue Madison, WI 53708-8935 Madison, WI 53703 FAX #: (608) 261-7083 E-Mail: email@example.com Phone #: (608) 266-2112 Website: http://dsps.wi.gov CONTROLLED
DSCSA Updates and Readiness Check: Requirements for Dispensers and other Trading Partners U.S. Food and Drug Administration Center for Drug Evaluation and Research July 2015 Who is a Dispenser? DISPENSER.
Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act) Overview and Implementation Connie Jung, RPh, PhD U.S. Food and Drug Administration NACDS Total Store Expo August 24, 2014
DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS DIRECTOR S OFFICE PHARMACY PROGRAM FOR UTILIZATION OF UNUSED PRESCRIPTION DRUGS (By authority conferred on the director of the department of licensing and
1 11 MEDICATION MANAGEMENT OVERVIEW OF MEDICATION MANAGEMENT Depending on the size, structure and functions of the health facility, there may be a pharmacy with qualified pharmacists to dispense medication,
Drug Diversion Provider Presentation Controlled Substance Prescribing and Diversion Angela Wallace, R.Ph. Coastal District Inspector, PMP Law Enforcement Officer DHEC Bureau of Drug Control Presentation
IAC 12/12/12 Pharmacy Ch 5, p.1 CHAPTER 5 PHARMACY SUPPORT PERSONS 657 5.1(155A) Definitions. For purposes of this chapter, the following definitions shall apply: Board means the Iowa board of pharmacy.
Intermec Security Letter of Agreement Dear Supplier, Please be advised that Intermec Technologies has joined US Customs and Border Protection (USC&BP) in the Customs-Trade Partnership Against Terrorism
School Based Emergency Medicine Class D Clinic NM Board of Pharmacy Policy and Procedure Manual School Based Emergency Medicine Class D Clinic REQUIRED FOR COMPLIANCE NM Board of Pharmacy Approved Policy
Core Standards for Medication Handling by Assertive Outreach, Crisis, Home Treatment and other Community Teams with Complex Medication Handling Needs version 3 For each team base where medicines are stored,
University of California Business and Finance Bulletin Office of the Executive Vice President Business Operations Number BUS 50 Controlled Substances Program Best Practices Guide http://www.ucop.edu/ucophome/policies/bfb/bus50.html
2.2 Drug Free Work Place Adopted 1.24.2003 Revised 3.28.2004; 5.26.2006; 3.2.2011 Reference: WAC 388.805.200(3) POLICY In accordance with "The Drug Free Workplace Act of 1988, The Healing Lodge prohibits
Ambulatory Surgical Centers Frequently Asked Questions Index Top General Definitions Compliance with State Licensure Laws Governing Body and Management Surgical Services Quality Assessment and Performance
Remote Automated Dispensing Machines in Long Term Care This technology is supported by DEA, CMS, EPA, and many state boards of pharmacy. See below for the NABP model rules, DEA Title 21 Sec. 1301.27 pertaining
Purchasing Card Program User Guidelines University of North Alabama Procurement Department Created: March 2008 / Updated 7/16/2015 University of North Alabama Purchasing Card Program 1 Table of Contents
State of Florida Department of Business and Professional Regulation Division of Drugs, Devices, and Cosmetics Application for a Retail Pharmacy Drug Wholesale Distributor Form.: DBPR-DDC-218 APPLICATION
Article 12A. Wholesale Prescription Drug Distributors. 106-145.1. Purpose and interpretation of Article. This Article establishes a State licensing program for wholesale distributors to enable wholesale
Purchasing Card Policies and Procedures I. PURPOSE To set forth the Policies and Procedures for the New Jersey City University Purchasing Card Program. II. POLICY 1. INTRODUCTION The New Jersey City University
Inventory Management Chapter Outline Inventory Management Inventory Systems Computer & Inventory Ordering Forms Stocking & Storing Inventory Management Inventory A listing of medication of the goods or
Last Name: Pharmacy Program Pre-Test * For each question, put a check mark for the one option that you think is correct. 1. A pharmacist receives a security prescription from a known local medical group
SOUTH LYON COMMUITY SCHOOLS 5330/page 1 of 6 ADMINISTRATION OF MEDICATION Definitions Medication includes both prescription and non-prescription medications including those taken by mouth, inhaler, injection,
COUNCIL POLICY NO. C-13 TITLE: POLICY: Identity Theft Prevention Program See attachment. REFERENCE: Salem City Council Finance Committee Report dated November 7, 2011, Agenda Item No. 3 (a) Supplants Administrative
CHRIS CHRISTIE Governor KIM GUADAGNO Lt. Governor Division of Consumer Affairs Office of the Director 124 Halsey Street, 7 th Floor, Newark NJ PHARMACY SECURITY BEST PRACTICES Published May 1, 2013 New
CONNECTICUT Downloaded January 2011 19 13 D8T. CHRONIC AND CONVALESCENT NURSING HOMES AND REST HOMES WITH NURSING SUPERVISION (d) General Conditions. (6) All medications shall be administered only by licensed
Import/ Export of Controlled Substances Import/ export can quickly become complicated: Some types of CS registrations allow import/ export as coincident activity (e.g., analytical), DEA/ US Customs requirements
SUBJECT: Primary Care Nurse Practitioners SECTION: CREDENTIALING POLICY NUMBER: CR-31 EFFECTIVE DATE: 10/04 Applies to all products administered by the plan except when changed by contract Policy Statement:
TYPE OR PRINT CLEARLY Wisconsin Department of Regulation & Licensing Mail To: P.O. Box 8935 Madison, WI 53708-8935 1400 E. Washington Avenue Madison, WI 53703 FAX #: (608) 261-7083 Phone #: (608) 266-2112
FACILITIES MANAGEMENT DEPARTMENT Policy Title: Key Control and Card Access Policy Policy Number D-12 Section: Safety and Security Effective Date: April 12, 2007 Last Review: April 12, 2007 Purpose: The
i ii MESSAGE FROM THE ADMINISTRATOR The Drug Enforcement Administration (DEA) is pleased to provide this guideline to assist in the understanding of the provisions of the Controlled Substances Act of 1970
HIPAA Employee Training Guide Revision Date: April 11, 2015 What is HIPAA? The Health Insurance Portability and Accountability Act of 1996 (also known as Kennedy- Kassebaum Act ). HIPAA regulations address
Not Protectively Marked Policy for the Storage and Administration of Medication in Custody Suites Policy Reference No. P22:2000 Portfolio Holder Assistant Chief Constable Policy Owner Superintendent Donnell
RULES OF THE TENNESSEE BOARD OF NURSING R 1000-04 ADVANCED PRACTICE NURSES AND CERTIFICATES TABLE OF CONTENTS 1000-04-.01 Purpose and Scope 1000-04-.07 Processing of Applications 1000-04-.02 Definitions
Food Defense Self-Assessment Checklist for Slaughter and Processing Plants Outside Security 1. What food defense measures does your plant have in place for the exterior of the building? Are the plant s
Title: Policy on Sample Medication Policy #: 450.80 Adopted: 1/90, 7/00 Revised: 3/95, 5/98, 7/00, 10/01 Reviewed: 7/00, 10/01, 02/03 This policy is applicable to the following Henry Ford Health System
Tulane Purchasing Card Policies and Procedures I. Purpose The Purchasing Card program was established to provide a more efficient and cost-effective method for purchasing and paying for small dollar transactions,
Effective Date: 09/12/06, 08/02/10, 3/2/11 Title: 1.0 OBJECTIVE: 1.1 This SOP describes the methods and policies for: Handling investigational drug Dispensing investigational drug 1.2. This procedure applies
Management of Controlled Substances in Dental Practice Dr. Michael O Neil Professor and Vice-Chair Department of Pharmacy Practice Drug Diversion, Substance Abuse and Pain Management Consultant South College
Knowledge replaces fear. Controlled Substances Record Keeping for Healthcare Practitioners in Illinois By Glen D. Crick, Attorney at Law Introduction This article applies only to medical doctors, dentists,
Name of Practice : Objectives To ensure implementation of the regulations and guidance on safe and secure handling of controlled drugs Scope To cover all aspects of obtaining controlled drug stock, handling,
World Health Organization WHO Technical Report Series, No. 908, 2003 Annex 9 Guide to good storage practices for pharmaceuticals 1 1. Introduction 125 2. Glossary 126 3. Personnel 128 4. Premises and facilities
247 CMR 9.00: CODE OF PROFESSIONAL CONDUCT; PROFESSIONAL STANDARDS FOR REGISTERED PHARMACISTS, PHARMACIES AND PHARMACY DEPART- MENTS Section 9.01: Code of Professional Conduct for Registered Pharmacists,