Ordering and Using Prescription Veterinary Drugs
Standard Operating Procedures for Ordering and Using Prescription Veterinary Drugs; Non-veterinary Controlled Substances, Controlled Substance Analogues and Chemical Precursors; and Controlled Glassware/Items.
The effective date of this document is September 22, 2006.
I. The Federal Government and the State of Texas regulates the ordering and use of all federally controlled and non-controlled veterinary drugs that could be considered "dangerous" as defined in Chapter 483 of the Texas Health and Safety Code (see attached) and Code of Federal Regulations (see attached). The State of Texas also regulates non-veterinary controlled substances, controlled substance analogues and controlled chemical precursors; and controlled glassware/items that could be used to produce dangerous drugs (see attached). Therefore, in an effort to self-regulate, we will use the following guidelines for all veterinary drugs; non-veterinary controlled substances, controlled substance analogues and controlled chemical precursors; and controlled glassware/items.
II. If you are ordering prescription veterinary drugs off of a School of Public Health account you must do the following:
A. The drug that you are ordering MUST be included in a protocol that was APPROVED by the Institutional Animal Care and Use Committee (IACUC).
B. The drug MUST be used in the manner specified in the approved protocol.
C. You may only order drugs from Butler Animal Health Supply, 5600 Blazer Pkwy Dublin, OH 43017 as they are the only veterinarian drug supplier that is authorized by our veterinarian to ship drugs to the College. If for some reason you need to use another supplier please contact the Office of Research and Graduate Studies.
III. Ordering Veterinary Drugs.
A. Ordering from a SPH account.
Enter the order in FAMIS making a note of the Document Number.
All Veterinary Drugs should be delivered to Lab manager.
Deliver the completed and signed form to the Purchasing Department. Keep a copy for your records.
B. From a Texas A&M Research Foundation account.
Use same accounts as other orders.
When ordering Veterinary Drugs, you must have Dr. Thomas McDonald’s signature for the order to be completed.
Deliver the completed and signed form to the Research foundation, keep a copy for your records and provide a copy to Research Office.
C. Receiving Drug Shipments.
All drug orders received from vendors will be delivered to Lab Manager
Items delivered from Butler Animal Health which are not drugs may be delivered directly to the end user.
D. Legal Requirements
According to FEDERAL LAW the investigator must keep a DAILY RECORD of the use of any controlled substance (Scheduled I, II, III, IV and V). You must record the drug into your log book immediately upon receiving the drug. The investigator must keep a regular inventory of the acquisition and use of any controlled substance. The amount of drug consumed in an experiment should be noted in the inventory log at the time of use.
According to STATE LAW the investigator must keep a DAILY RECORD of any dangerous drug (see Attached). A dangerous drug is defined as a drug that requires a prescription from a Doctor of Veterinary Medicine, but is not a controlled substance.
The United States Department of Agriculture Animal Plant Health Inspection Service Veterinarian requires that drugs, used in animals, which are out-of date be marked out of date, on the container, and kept separate from drugs that are in-date. Certain out of date drugs can be used in terminal studies, however when the drugs are two months out-of-date they must be destroyed or re-certified by the manufacturer that they are still usable. See the staff veterinarian to determine if an out of date drug can be used in a terminal study.
Out-of-date and unused drugs should be given to the Safety and Health Department for disposal.
E. The Federal and State drug enforcement agencies can make unannounced visits to inspect drug log books. Controlled and dangerous veterinary drugs that are received must be logged into the drug book on the day they are delivered to the investigator.
F. All drugs must be stored in an approved drug lock box. Access to rooms and locked storage areas containing controlled substances, controlled substance analogues, and chemical precursors must be restricted to authorized personnel.
G. All drug lock boxes and drug books will be inspected once a year by Lab Manager and department head. The inspection will take place with both inspectors present at the same time and they will determine that the drugs (opened or unopened) have not expired. Expired drugs will be disposed of as outlined in this policy. Drug books will be checked for accuracy and any discrepancies reported to the Research Office.
H. Upon the discovery of the loss of a drug the incident must be immediately reported to Dr. Thomas McDonald who will report the incident to the Associate Dean for Research, School of Public Health and the Vice President for Research.
I. Positions having access to controlled substances, controlled substance analogues, and chemical precursors are designated as security sensitive and appropriate pre-employment criminal history checks must be performed.
J. The School of Public Health is required to submit their controlled substance policy and their updated list of faculty and staff in possession of controlled substances, controlled substance analogues, or chemical precursors to the Office of the Vice President for Research annually. This report is to be sent every two years prior to April 15 of the current year.
K. Questions: call Dr. Thomas McDonald, 979-458-4267.
IV. Non-veterinary Controlled Substances Controlled Substance Analogues and Chemical Precursors
Any drug listed in the “Memorandum of Understanding between the Texas Department of Public Safety and the Texas Higher Education Coordinating Board” (see attached) is subject to the same ordering, storage and record keeping procedures as listed in I-IV. If the size of the drug container will not permit the dangerous drug/precursor it to be stored in the drug lock box then it must be stored in a locked cabinet.
V. Controlled glassware/items
A. Controlled Glassware is defined as condensers; distilling apparatus; single, two- and three-necked flasks; distilling flasks; Florence flasks; filter funnels; Buchner funnels; separatory funnels; Erlenmeyer flasks; round-bottom flasks; thermometer flasks; filtering flasks; Soxhlet extractors; and adapter tubes made of glass. Controlled items are defines as tableting machines, encapsulating machines, flask heaters, heating mantles, transformer and vacuum dryers.
B. Investigators that currently contain the items listed in VI. A. must notify the Associate Dean for Research at SPH stating what type and quantity of controlled glassware they have in their laboratory.
C. When controlled glassware is ordered the investigator must keep a copy of the purchase order so this glassware can be inventoried with current onsite glassware listed in V.A. above.
D. If any controlled glassware is stolen the investigator must immediately notify Dr. Thomas McDonald who will notify the Associate Dean of Research, The School of Public Health and the Vice President for Research. No controlled glassware may be given to the general public.
* The State of Texas Health and Safety Code document can be found in the Appendix.
Memorandum of Understanding
Texas Department of Public Safety
Texas Higher Education Coordinating Board
Pursuant to Texas Health and Safety Code, Section 481.0621 (b), the Texas Department of Public Safety (DPS) and the Texas Higher Education Coordinating Board (THECB) enter into this memorandum of understanding in order to establish the responsibilities of the DPS, the THECB, and the public or private institutions of higher education for implementing and maintaining a program for reporting information concerning controlled substances, controlled substance analogues, chemical precursors, and chemical laboratory apparatus used in education or research activities of institutions of higher education.
(a) Agent -any peace officer or other person who is authorized by law to enforce or administer state or federal drug laws.
(b) Central Location -location within an institution of higher education where records are maintained.
(c) 21 CFR, Part 1301 -21 Code of Federal Regulations, Part 1301 to End, providing for the Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances and any amendments to these regulations hereafter adopted.
(d) Client -any person or entity to which DPS has issued a permit authorizing the purchase, sale, transfer or furnishing of a controlled item.
(e) Controlled Glassware -condensers; distilling apparatus; vacuum dryers; single, two-and three-necked flasks; distilling flasks; Florence flasks; filter funnels; Buchner funnels; separatory funnels; Erlenmeyer flasks; round-bottom flasks; thermometer flasks; filtering flasks; Soxhlet extractors; and adapter tubes made of glass.
(f) Controlled Item -precursor chemicals and laboratory apparatus listed in Texas Health and Safety Code Section 481.002 (51) and 481.002 (53) and as named by rule by the Director of the Department of Public Safety pursuant to the Texas Health and Safety Code Section 481.077(b) and 481 .08O(c).
The table below lists the controlled items as of September 1. 2005.
|I Precursor Chemicals I||
Laboratory Apparatus I
|1. Methylamine||A. Condensers|
|2. Ethylamine||B. Distilling apparatus|
|3. D-lysergic acid||C. Vacuum dryers|
|4. Ergotamine tartrate||D. Three-necked flasks|
|5. Diethyl malonate||E. Distilling flasks|
|6. Malonic acid||F. Tableting machines|
|7. Ethyl malonate||G. Encapsulating machines|
|8. Barbituric acid||H. Filter funnels, buchner funnels, and|
|9. Piperidine||separatory funnels|
|10. N-acetylanthranilic acid||I. Erlenmyer flasks, two-necked flasks, single|
|11. Pyrrolidine||neck flasks, round-bottom flasks, Florence|
|12. Phenylacetic acid||flasks, thermometer flasks, and filtering flasks|
|13. Anthranilic acid||J. Soxhlet extractors|
|14. Hypophosphorus acid||K. Transformers|
|15. Ephedrine||L. Flask heaters|
|16. Pseudoephedrine||M. Heating mantles|
|17. Norpseudoephedrine||N. Adapter tubes|
|19. Red phosphorus|
(g) Controlled Substance -a substance, including a drug, an adulterant and a dilutant as defined by the Health and Safety Code, Chapter 481, the Texas Controlled Substances Act.
(h) Controlled Substance Analogue -(1) a substance with a chemical structure substantially similar to the chemical structure of a controlled substance in Schedule I or II or Penalty Group 1, 1-A, or 2 of the Texas Health and Safety Code, Chapter 481, Texas Controlled Substances Act; and (2) a substance specifically designed to produce an effect substantially similar to, or greater than, the effect of a controlled substance in Schedule I or I1or Penalty Group 1, 14, or 2 of the Texas Health and Safety Code, Chapter 481, Texas Controlled Substances Act.
(i) DPS -Department of Public Safety Narcotics Service Regulatory Program that is charged with the regulation of controlled substances and items listed in this MOU
(j) Institution of Higher Education or Institution -this term includes an institution of higher education, as defined in Texas Education Code, Section 61.003(8), a private or independent institution of higher education, as defined in Texas Education Code, Section 61.003(15). and a private postsecondary educational institution. as defined in Texas Education Code, Section 61.302(2).
(k) MOU -memorandum of understanding as required by the Texas Health and Safety Code, Section 481.0621 (b).
(l) Nar-22 -form prepared and issued by DPS Narcotics Service to clients to report sale, transfer, or furnishing of a controlled substance or item.
(m) Site -a specific location at an institution where controlled items are utilized and/or stored.
(n) THECB -Texas Higher Education Coordinating Board.
(o) Unacceptable Discrepancy -any difference in the amount on hand and the amount documented that cannot reasonably be explained by accidental or normal loss.
Institutions of higher education in Texas shall adopt procedures in compliance with this MOU. When requested, the DPS shall provide technical advice to the institution or site, and
educational materials or presentations if funds and personnel are available.
3-RECORDS AND REPORTS
(a) The site shall maintain all purchase order records, in accordance with the minimum retention requirements established by the Texas State Library and Archives Commission, of the incoming controlled substances, controlled substance analogues, precursor chemicals and laboratory apparatus (including controlled glassware) covered in this MOU that have been purchased or received by the site or central location.
(b) An institution or site that discovers a readily unacceptable discrepancy, loss, pilferage or theft of a controlled substance, controlled substance analogue, precursor chemical or laboratory apparatus (including controlled glassware) shall submit a written report of the incident to the appropriate law enforcement agency no later than 5 business days after the date of discovery of the discrepancy, loss, pilferage or theft. The institution shall forward the report to DPS within 5 additional business days after the report is submitted to the appropriate law enforcement agency.
(c) Upon request, the DPS shall assist the law enforcement agency conducting an investigation regarding the pilferage or theft of the controlled substance, precursor chemical, or laboratory apparatus named in this MOU.
(d) The DPS may request that an institution or site provide a duplicate of any record(s) covered by this MOU and the institution or site shall provide such record(s) within 10 business days of the request. The record(s) may be provided in electronic or hard copy form.
4-SALE. TRANSFER OR FURNISHING OF CONTROLLED ITEMS
(a) The institution or site shall prohibit the sale, furnishings, or transfer of controlled items, including glassware, covered by this MOU to any person or entity not holding a DPS permit, unless the recipient is specifically exempted by law or rule.
(b) The institution shall report to the DPS on a Nar-22 form or any form mutually agreed upon by all parties, every sale, furnishing or transfer of a controlled item leaving the institution. The site shall submit these reports to the DPS within 30 days of the furnishing or transfer of the controlled items. This report shall include the name, address, telephone number, permit number (if applicable), driver license number, and date of birth of the client receiving the controlled items.
5-CONTROLLED SUBSTANCES AND CONTROLLED SUBSTANCE ANALOGUES
(a) The institution or site is responsible for complying with the established procedures as required in 21 CFR. Part 1301 to End and as required by any amendments to 21 CFR Part 1301.
(b) Upon request, the DPS shall provide technical advice to the institution or site regarding the inventories required in 21 CFR, Part 1301 to End.
(c) Upon request, the DPS shall assist the law enforcement agency conducting any investigation regarding any significant loss, pilferage or theft of the controlled substances or controlled items contained in this MOU.
6-AUDITS AND INSPECTIONS
The institution or site shall permit any DPS agent to conduct audits and inspections of all records made in accordance with the MOU at any reasonable time and shall not interfere with the discharge of the agent's duties.
7-SECURITY AND STORAGE
The institution or site shall ensure the security of the controlled items by cost-effective means that afford a reasonable sense of safety and accountability, such as electronic records keeping and physical security. In addition, the institution or site shall require that the controlled substances and precursor chemicals are stored in accordance with recommendations of the manufacturer, the Texas Commission on Environmental Quality and the Federal Environmental Protection Agency.
Each institution or site shall appoint one or more individuals, as needed, to be responsible for implementing the security measures established by the institution or site. The institution shall annually provide a list of these individuals to the DPS and shall ensure that these individuals serve as the contact between the institution and the DPS. The initial list of contact persons shall be provided within ninety (90) days after the effective date of this Memorandum of Understanding.
The general provisions of this Memorandum of Understanding shall be effective on the date of signature by representatives of both parties. This agreement, upon review of both parties, may be amended by written agreement whenever such action is necessary.
Date: 6 13 06
Thomas A Davis, Jr.
Texas Department of Public Safety
Date 5 24 06
Texas Higher Education Coordinating Board
Suggestions for Implementing MOU Procedures
Notify all personnel involved with environmental and safety issues about the MOU
Notify all science and health laboratory personnel about the MOU.
Provide information to appropriate personnel regarding the potential problem of diversion of laboratory chemicals and apparatus to illegal drug operations.
Notify the Department of Public Safety (DPS) of the person designated to act as the liaison between the institution and the DPS.
Notify all personnel involved in the sale or transfer of surplus equipment that none of the precursor chemicals or laboratory apparatus, including glassware, listed as controlled items in the MOU should be sold or otherwise transferred to anyone who does not have the proper permit or the specific authority to purchase or accept the controlled items. Personnel involved in the transfer or sale of these items should be provided with copies of the Nar-22 form, which should be used to report the sale, transfer, or furnishing of the listed precursor chemicals or laboratory apparatus. Any party involved in an auction of surplus equipment should be informed of the MOU.
Establish procedures to assure an appropriate level of security for controlled items in educational and research laboratories and storerooms. Designate an individual to be responsible for establishing security measures.
Encourage all personnel to be alert and attentive to the disappearance of any of the controlled items and to report losses to the institution's contact person for controlled substances.