Proposed Rules Title 37

TITLE 37. PUBLIC SAFETY AND CORRECTIONS

Part 1. TEXAS DEPARTMENT OF PUBLIC SAFETY

Chapter 13. CONTROLLED SUBSTANCES

Subchapter A. GENERAL PROVISIONS

37 TAC §13.1, §13.9

The Texas Department of Public Safety proposes amendments to Chapter 13, §13.1 and §13.9, concerning General Provisions. The proposed amendment to §13.1 reformats the section in order to add new definitions for individual practitioner, institutional practitioner, and mid-level practitioner and deletes the definition for triplicate prescription form. The proposed amendment to §13.9 is necessary in order to correct the fax number for the Texas Prescription Program.

Oscar Ybarra, Chief of Finance, has determined that, for each year of the first five-year period the proposed rule amendments are in effect, there will be no fiscal implications for state or local government, or local economies.

The department has determined that Chapter 2007 of the Government Code does not apply to these rules. Accordingly, the department is not required to complete a takings impact assessment regarding these proposed rule amendments.

Comments on the proposal may be submitted to Johnny Hatcher, Narcotics Regulatory Programs, MSC 0433, Texas Department of Public Safety, P.O. Box 4087, Austin, Texas 78773-0433; or by electronic mail to johnny.hatcher@txdps.state.tx.us. The department will accept comments for 30 days after publication in the Texas Register . For further information, call Johnny Hatcher at (512) 424-2458.

The amendments are proposed pursuant to Texas Health and Safety Code, §481.003, which authorizes the director to adopt rules to administer and enforce the Texas Controlled Substances Act.

Texas Health and Safety Code, §481.003, is affected by this proposal.

§13.1.Chapter Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise.

(1) Act--The Texas Controlled Substances Act (Texas Health and Safety Code, Chapter 481).

(2) Administer, abuse unit, adulterant or dilutant, agent, controlled premises, controlled substance, controlled substance analogue, deliver, delivery, designated agent, director, dispense, distribute, distributor, drug, drug paraphernalia, Federal Drug Enforcement Administration, hospital, institutional practitioner, lawful possession, manufacture, marihuana, medication order, narcotic drug, official prescription form, opiate, patient, person, pharmacist, pharmacist-in-charge, pharmacy, possession, practitioner, prescribe, prescription, principal place of business, and registrant--Have the meanings assigned those terms by the Act, §481.002.

(3) CSR--Controlled Substances Registration.

(4) Day--means a calendar day unless the context clearly indicates another meaning such as a business day.

(5) Department or DPS--The Texas Department of Public Safety.

(6) Drug Enforcement Administration or DEA--The Federal Drug Enforcement Administration.

(7) Individual practitioner--A physician, dentist, veterinarian, optometrist, podiatrist, or other individual licensed, registered, or otherwise permitted to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy, or an institutional practitioner.

(8) [ ~~(7)~~ ] Inhalant paraphernalia--An item or other material defined as such by Texas Health and Safety Code, [ ~~§484.001 or~~ ]§485.001.

(9) Institutional practitioner--A hospital or other person (other than an individual) licensed, registered, or otherwise permitted to dispense a controlled substance in the course of professional practice, but does not include a pharmacy.

(10) [ ~~(8)~~ ] Laboratory apparatus--An item subject to Subchapter E of this chapter (relating to Precursors and Apparatus).

(11) [ ~~(9)~~ ] Licensed vocational nurse or LVN--An individual recognized as a licensed vocational nurse by the Texas Board of Vocational Nurse Examiners.

(12) [ ~~(10)~~ ] Long-term care facility or LTCF--An establishment licensed as such by the Texas Department of Aging and Disability [ ~~Human~~ ] Services.

(13) Mid-level practitioner--An individual practitioner, other than a physician, dentist, veterinarian, optometrist, or podiatrist, who is licensed, registered, or otherwise permitted to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners include, but are not limited to, health care providers such as advanced nurse practitioners and physician assistants who are authorized to dispense controlled substances.

(14) [ ~~(11)~~ ] Narcotic controlled substance--A narcotic drug or other controlled substance that contains opium or an opiate derivative.

(15) [ ~~(12)~~ ] Non-narcotic controlled substance--A controlled substance that does not contain opium or an opiate derivative.

(16) [ ~~(13)~~ ] PCLAS--The Precursor Chemical/Laboratory Apparatus Section.

(17) [ ~~(14)~~ ] Physician assistant--An individual licensed as such by the Texas State Board of Physician Assistant Examiners.

(18) [ ~~(15)~~ ] Precursor chemical--A substance subject to Subchapter E of this chapter (relating to Precursors and Apparatus).

(19) [ ~~(16)~~ ] Readily retrievable record--A record created and maintained by an automatic data processing or mechanized record keeping system so that a particular type of record can be separated from all other records in a reasonable time. The term includes a record created and maintained by annotation of each material item with an asterisk, redline, or some other manner visually identifiable apart from all other items appearing on the required record.

(20) [ ~~(17)~~ ] Record--A notification, order form, statement, invoice, prescription, inventory information, or other document for the acquisition or disposal of a controlled substance, precursor, or apparatus in any manner by a registrant or permit holder under a record keeping or inventory requirement of federal law, the Act, or this chapter.

(21) [ ~~(18)~~ ] Registered nurse--An individual recognized as such by the Texas Board of Nurse Examiners.

(22) [ ~~(19)~~ ] Schedule II--A list of narcotic and non-narcotic controlled substances found in the most current version of Schedule II as established or altered by the commissioner of health under the Act, Subchapter B, and published in the Texas Register.

~~[ ~~(20)~~ Triplicate prescription form--A type of official prescription form.]~~

§13.9.Telephone Number and Address - Texas Prescription Program.

To inquire about information and administrative matters with, transmit to, or otherwise contact the Texas Prescription Program:

(1) the telephone number is: (512) 424-2189;

(2) the fax number is: (512) 424-5373 [ ~~424-5799~~ ];

(3) the Post Office Box mailing address is: Texas Prescription Program MSC 0439, Texas Department of Public Safety, P.O. Box 4087, Austin, Texas 78773-0439;

(4) the fee or payment address is: Texas Prescription Program MSC 0439, Texas Department of Public Safety, P.O. Box 15999, Austin, Texas 78761-5999;

(5) the physical mailing address is: Texas Prescription Program MSC 0439, Texas Department of Public Safety, 5805 N. Lamar Blvd., Austin, Texas 78752-4422; and

(6) the e-mail address is through the department's web page at "www.txdps.state.tx.us" or directly through "tppcsr@txdps.state.tx.us."

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2007.

TRD-200702558

Thomas A. Davis, Jr.

Director

Texas Department of Public Safety

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 424-2135

Subchapter B. REGISTRATION

37 TAC §§13.21, 13.22, 13.24 - 13.30

The Texas Department of Public Safety proposes amendments to Chapter 13, §§13.21, 13.22, and 13.24 - 13.30, concerning Registration. Due to legislation from the 79th Regular Legislative Session in HB 164, regarding the distribution and retail sales of certain chemical substances, Texas Health and Safety Code, §481.077, was modified and Texas Health and Safety Code, §481.0771, was created. Based on the changes to the law, it is necessary to propose revisions and additional clarification of current rules for permitting and reporting the distribution and sales of certain chemical substances. Some changes have been made to reflect recent changes made to federal regulations and to accommodate current business processes. Additional non-substantive changes have also been included to improve clarity throughout the chapter. In addition, several sections have been reformatted to include the addition of mid-level practitioner to the list of groups that must register and to add rules about separation from delegating physician, the return of unexpired certificates, and compliance measures.

Mr. Ybarra also has determined that, for each year of the first five-year period the proposed rule amendments are in effect, the public benefit anticipated as a result of enforcing the rules will be current and updated rules. There is no adverse economic impact anticipated for small businesses or micro-businesses. The anticipated cost to individuals who are required to comply with the section as proposed is the $25.00 non-refundable processing fee required for an original or renewal registration.

The amendments are proposed pursuant to Texas Health and Safety Code, §481.003, which authorizes the director to adopt rules to administer and enforce the Texas Controlled Substances Act.

Texas Health and Safety Code, §481.003, is affected by this proposal.

§13.21.Who Must Register.

(a) Required by Act. A person, who is required by the Act to register in order to manufacture, distribute, prescribe, possess, analyze, dispense, or conduct research with a controlled substance, must obtain an annual registration from the director (CSR Section).

(b) Generally. Only a person actually engaged in an activity covered by the registration provisions of the Act must obtain a registration. A related or affiliated person who is not engaged in a covered activity is not required to register.

(1) practitioner;

(2) pharmacy;

(3) hospital;

(4) manufacturer;

(5) researcher;

(6) teaching institution;

(7) distributor;

(8) analyst or analytical lab; [ or ]

(9) peyote distributor ; or [ . ]

(10) mid-level practitioner.

(d) Schedules. The director may register a person for one or more of the following schedules:

(1) Schedule I;

(2) Schedule II (narcotic);

(3) Schedule II (non-narcotic);

(4) Schedule III (narcotic);

(5) Schedule III (non-narcotic);

(6) Schedule IV; or

(7) Schedule V.

(e) Lawful possession. A registrant may lawfully possess a controlled substance to the extent authorized by the registration.

(f) An applicant may apply for registration as a manufacturer, researcher, teaching institution, distributor, analyst, or analytical laboratory only after obtaining the appropriate registration from DEA.

§13.22.Registration for Certain Activities.

(a) Schedule I.

(1) A person who is seeking registration to conduct research with a Schedule I controlled substance must comply with the Act, §481.065(b) and submit a research protocol to the director for approval. Under this subsection, the person may submit a duplicate of a protocol submitted to DEA for the same research authority. Once submitted, the protocol becomes a part of the application for all purposes. If approved by the director, the person may conduct research only:

(A) [ ~~(1)~~ ] in the manner expressly detailed in the protocol; and

(B) [ ~~(2)~~ ] using a controlled substance expressly specified in the protocol.

(2) [ ~~(b)~~ ] Without DEA registration. If the director determines registration is appropriate to minimize a risk of diversion or abuse of a controlled substance, the director may register a person who:

(A) [ ~~(1)~~ ] has not applied for registration with DEA; or

(B) [ ~~(2)~~ ] is not a registrant with DEA.

(b) Schedules II - V.

(1) A person who is seeking registration to possess, prescribe or dispense a Schedule II - V controlled substance must comply with the Act, §481.061.

(2) A provider pharmacy of a long term care facility must comply with the Texas Pharmacy Act and rules.

§13.24.Exemption from Registration.

A person is exempt from registration, need not register, and may lawfully possess a controlled substance under the Act if the person is:

(1) exempted from registration under the Act, §481.062;

(2) excepted from the Act, Subchapter C, under the Act, §481.0621; or

(3) exempted from federal registration under the Code of Federal Regulations, Title 21, Chapter II, §§1301.22 - 1301.24 [ ~~§§1301.22 - 1301.25~~ ].

§13.25.Application.

(a) Required. A person required to register under this subchapter must comply with this subchapter and Subchapter F of this chapter (relating to Applications).

(b) Form. An applicant must make:

(1) a new or original application on DPS Form NAR-77 or NAR-77a ; and

(2) a renewal application on DPS Form NAR-78 or NAR-78a .

(c) Rejection. An applicant, who seeks to renew a registration, may correct a rejected or defective application and resubmit it for filing at any time before termination under §13.30 of this title (relating to Termination).

§13.26.Certificate.

(a) Issuance. The director will issue a certificate of registration to an applicant who qualifies for registration or renewal under the applicable provisions of the Act, Subchapter C, and this subchapter.

(b) NAR-79. The director will issue a [ ~~the~~ ] certificate to a registrant listed in §13.21(c)(1) - (9) of this title (relating to Who Must Register) on DPS Form NAR-79, containing:

(1) the registrant's name and address;

(2) the registration number;

(3) the business activity authorized by the registration;

(4) each schedule the registrant is authorized to handle;

(5) a "[ ~~fee~~ ] paid" or "exempt" notation;

(6) a "duplicate" notation, if the certificate is a duplicate;

(7) the certificate's issue date; and

(8) the certificate's expiration date.

(1) the information listed in §13.26(b) of this title (relating to Certificate); and

(2) the name of the supervising physician delegating prescriptive authority.

(d) [ ~~(c)~~ ] Display. The registrant must:

(1) display the certificate at the physical location of the registrant's principal place of business; or

(2) maintain the certificate so the registrant may promptly retrieve and display it at any time upon proper demand.

§13.27.Fee.

(a) Amount. To apply for an original or renewal registration to manufacture, distribute, prescribe, possess, analyze, dispense, or conduct research with a controlled substance, the applicant must pay a non-refundable processing [ ~~registration~~ ] fee of $25.

(b) Submission. An applicant must submit the fee with the original or renewal application to the director (CSR Section).

(c) Acceptable manner. The applicant must make payment in the form of a check or money order, payable to the "Texas Department of Public Safety," or another form of payment authorized by a general rule or policy of the department.

(d) Prohibited manner. The director will not accept a fee payment in the form of:

(1) stamps;

(2) foreign currency;

(3) a check or money order, payable in foreign currency; or

(4) a third-party endorsed check.

(e) Multiple or additional fees. The director:

(1) may charge multiple fees for registrations to one person at each different location and for each different business activity; and

(2) will not charge an additional fee for each different schedule processed on a single registration application.

§13.28.Fee Exemption.

(a) Requirements. The director may exempt a person from payment of a state fee for registration or renewal, if the person's superior certifies on the DPS Form NAR-77 , NAR-77a, [ or ] NAR-78 , or NAR-78a that the person is exempted from payment of a fee under the Code of Federal Regulations, Title 21, Chapter II, §1301.21 and is registered in Texas .

(b) Effect. Exemption from payment of a new registration or renewal fee:

(1) authorizes the registrant, where applicable, to acquire, possess, or handle a controlled substance only at the exempt location; and

(2) does not relieve the registrant of another requirement or duty prescribed by law.

§13.29.Expiration.

(a) Annual. Except as provided by subsection (c) of this section, an original certificate of registration expires after one year from the month of issuance indicated on the original certificate.

(b) Effect of modification or renewal. Except as provided by subsection (c) of this section, a modification in registration or an early renewal does not affect a current or future date of expiration.

(c) Extension. The director may extend the expiration date of a registration for a period of less than 12 additional months, if the director determines the extension is necessary to evenly allocate the expiration dates of all certificates.

(d) Effect of expiration. After expiration, the former registration provides the registrant with no authority to manufacture, distribute, prescribe, possess, analyze, dispense, or conduct research with a controlled substance.

(e) Renewal of expired number [ ~~Grace period~~ ]. After expiration under this section, a former registrant may apply for a new registration. During a six-month [ ~~grace~~ ] period after expiration and before termination under §13.30(a)(1) of this title (relating to Termination), the director (CSR Section) may reserve the original registration number in the name of the original applicant.

§13.30.Termination.

(a) When. A registration terminates:

(1) at the end of [ ~~a grace period of~~ ]six months [ ~~allowed by the director~~ ] after expiration [ ~~under this subchapter~~ ];

(2) when a regulatory board or DEA accepts a voluntary surrender, or denies, suspends, or revokes a license or a federal controlled substance registration; or

(3) when the person dies, ceases legal existence, or discontinues business or professional practice.

(b) New registration required. After termination, a former registrant must apply for a new registration and may be issued a different registration number.

(c) Effect of termination. After termination, the former registration provides the registrant with no authority to manufacture, distribute, prescribe, possess, analyze, dispense, or conduct research with a controlled substance.

(d) Discontinued activity. On the day a registrant discontinues business or professional practice, the registrant or a representative of the registrant must notify the director (CSR Section) by close of business. The director may immediately terminate the registration of a person reported to the director under this subsection.

(e) Mid-level practitioner. Upon dissolution of a professional relationship between a mid-level practitioner and the delegating physician, the mid-level practitioner has no authority to distribute, prescribe, possess, or dispense a controlled substance. If the mid-level practitioner does not have a new delegating physician certifying delegation within 60 days after the dissolution of such relationship, the director may terminate the registration of the mid-level practitioner.

(f) Return certificate. A registrant must return a terminated certificate within 30 days after termination if the certificate is not expired.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2007.

TRD-200702559

Thomas A. Davis, Jr.

Director

Texas Department of Public Safety

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 424-2135

Subchapter D. OFFICIAL PRESCRIPTIONS

37 TAC §§13.73, 13.78, 13.81, 13.82, 13.84

The Texas Department of Public Safety proposes amendments to Chapter 13, §§13.73, 13.78, 13.81, 13.82, and 13.84, concerning Official Prescriptions. Due to legislation from the 79th Regular Legislative Session in HB 164, regarding the distribution and retail sales of certain chemical substances, Texas Health and Safety Code, §481.077 was modified and Texas Health and Safety Code, §481.0771 was created. Based on the changes to the law, it is necessary to propose revisions and additional clarification of current rules for permitting and reporting the distribution and sales of certain chemical substances. Some changes have been made to reflect recent changes made to federal regulations and to accommodate current business processes. Additional non-substantive changes have also been included to improve clarity throughout the chapter. Further amendments delete instructions for use of triplicate prescription forms and specify minimum monthly prescription thresholds.

Oscar Ybarra, Chief of Finance, has determined that for each year of the first five-year period the rules are in effect there will be no fiscal implications for state or local government, or local economies.

Mr. Ybarra also has determined that for each year of the first five-year period the rules are in effect the public benefit anticipated as a result of enforcing the rules will be current and updated rules. There is no adverse economic impact anticipated for individuals, small businesses, or micro-businesses.

The amendments are proposed pursuant to Texas Health and Safety Code, §481.003, which authorizes the director to adopt rules to administer and enforce the Texas Controlled Substances Act.

Texas Health and Safety Code, §481.003 is affected by this proposal.

§13.73.Form.

(a) Use. A practitioner may issue a prescription for a Schedule II controlled substance only on an official Texas prescription form , which includes single or multiple copy forms . This subsection also applies to a prescription issued in an emergency situation.

(b) Refills prohibited. A Schedule II prescription may not be refilled.

(c) Completion. A practitioner who prescribes any quantity of a Schedule II controlled substance must complete an official prescription form by legibly filling in the spaces provided.

(d) Other requirements. A practitioner:

(1) may not postdate an official prescription; and

(2) must ensure all information on the prescription is legible on all copies, including stamped or preprinted instructions.

[ ~~(e)~~ Triplicate prescription. When a practitioner uses a triplicate prescription to prescribe a Schedule II controlled substance to a patient in a non-emergency situation, the practitioner must detach Copy 1 and Copy 2 without separation and give both copies to the patient to take to the pharmacy for filling.]

§13.78.Waiver from Electronic Reporting.

(a) Minimum prescription threshold. If a pharmacy fills less than 15 [ ~~a small number of reportable~~ ] prescriptions per month , the pharmacy may request from the director a waiver from electronic reporting. If a waiver is granted, the pharmacy must file reportable prescriptions with the director on a form approved under §13.79(c) of this title (relating to Pharmacy Responsibility - Non-electronic Reporting).

(b) Inadequate technology. If a pharmacy is not automated or cannot meet the requirements in §13.77 of this title (relating to Electronic Compatibility), the pharmacy may request from the director a waiver from electronic reporting. The request must clearly describe the technological inadequacies in the pharmacy.

(d) Duration. If granted, the waiver will remain in effect for no longer than twelve months, beginning the first day of the month following the month the waiver was granted.

§13.81.Pharmacy Responsibility- Questionable Prescription.

If a dispensing pharmacist receives an official prescription form that creates a substantial question or doubt in the mind of the dispensing pharmacist, the pharmacist must, before filling the prescription, communicate with [ ~~the patient or~~ ] the prescribing practitioner in order to resolve the question or doubt.

§13.82.Pharmacy Responsibility- Out-of-State Practitioner.

(a) If a pharmacist in this state receives a prescription, that is not on an official prescription form, that is for a Schedule II controlled substance, and that is issued by a practitioner in another state, the pharmacy may fill the prescription if:

(1) the practitioner is authorized by the other state to prescribe the substance;

(2) the pharmacy has a plan approved by and on file with the director allowing the activity; and

(3) the pharmacy processes and submits the prescription according to the reporting requirements approved in the plan.

(b) The approval of the plan will run concurrently with the pharmacy's registration.

§13.84.Release of Non-statistical Information.

(a) To whom. The director may release Texas Prescription Program information obtained under the Act, §481.075 only to an individual listed in the Act, §481.076(a).

(b) Purpose. An individual described by subsection (a) of this section may only request information for a purpose listed in the Act, §481.076.

(c) Written request. The director may require an individual seeking information under this section to submit a written request to the director before the director releases to the individual the information contained on or derived from the prescription.

(d) Proper need and Return of Information report. The director will require a person requesting information under the Act, §481.076(a)(3), to show a proper need for the information. The showing of proper need is ongoing. The director will [ ~~may~~ ] require the person to periodically submit to the director a Return of Information report documenting use of the information and the status of the investigation or prosecution.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2007.

TRD-200702560

Thomas A. Davis, Jr.

Director

Texas Department of Public Safety

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 424-2135

Subchapter E. PRECURSORS AND APPARATUS

37 TAC §§13.101, 13.103, 13.104, 13.107 - 13.117

The Texas Department of Public Safety proposes amendments to Chapter 13, §§13.101, 13.103, 13.104, 13.107 - 13.110 and new §§13.111 - 13.117, concerning Precursors And Apparatus. Due to legislation from the 79th Regular Legislative Session in HB 164, regarding the distribution and retail of certain chemical substances, Texas Health and Safety Code, §481.077 was modified and Texas Health and Safety Code, §481.0771 was created. Based on the changes to law, it is necessary to propose revisions and additional clarification of current rules for permitting and reporting the distribution and sales of certain chemical substances. Additional non-substantive changes have also been included to improve clarity, and to streamline and clarify procedures and terminology throughout the chapter.

New §13.111 is necessary in order to identify excluded substances, while new §13.112 is necessary in order to identify new statutory requirements for the reporting of ephedrine, pseudoephedrine, and norpseudoephedrine wholesales, including a provision for the reporting of suspicious quantity orders. Current §§13.112 - 13.116 are simultaneously being repealed and proposed as new §§13.113 - 13.117.

The amendments and new sections are proposed pursuant to Texas Health and Safety Code, §§481.003, 481.077, 481.0771, and 481.080, which authorizes the director to adopt rules to administer and enforce the Texas Controlled Substances Act.

Texas Health and Safety Code, §§481.003, 481.077, 481.0771, and 481.080 are affected by this proposal.

§13.101.Subchapter Definitions.

The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.

(1) Annual permit--A permit issued to a person by the director under this subchapter authorizing the person to receive or deliver a precursor or apparatus for one year from the date of issue or renewal.

(2) Apparatus--An item of chemical laboratory equipment covered by this subchapter, that is designed, made, or adapted to manufacture a controlled substance or a controlled substance analogue. This [ ~~The~~ ] term:

(A) does not include any item expressly deleted from the list of apparatus in §13.116 [ ~~§13.115~~ ] of this title (relating to Additions or Deletions) after being determined by the director to no longer jeopardize public health and welfare by evidenced proliferation or use in clandestine laboratories or other illicit manufacturer of a controlled substance or controlled substance analogue; and

(B) includes, except as provided by subparagraph (A) of this paragraph:

(i) any item listed under the Act, §481.080(a); and

(ii) any additional items expressly named to the list in §13.116 [ ~~§13.115~~ ] of this title (relating to Additions or Deletions) after being determined by the director to jeopardize public health and welfare by evidenced proliferation or use in clandestine laboratories or other illicit manufacturer of a controlled substance or controlled substance analogue.

(3) Clandestine laboratory--An illicit chemical laboratory or similar operation consisting of a sufficient combination of precursor and apparatus items used or usable in the illicit manufacture or synthesis of a controlled substance or a controlled substance analogue.

(4) Deliver--To sell, transfer, or otherwise furnish a precursor or apparatus. The term includes taking an order to furnish a precursor or apparatus.

(5) Distributor--A manufacturer, wholesaler, broker, repacker, jobber, association, corporation, partnership [ ~~retailer~~ ], or a person who sells, transfers, or otherwise furnishes a precursor or apparatus.

(6) - (11) (No change.)

(12) Precursor or chemical precursor--A chemical substance item covered by this subchapter and commonly used in the illicit manufacture of a controlled substance or a controlled substance analogue.

(A) The term includes:

(i) a chemical precursor listed under the Act, §481.002(51); and

(B) The term does not include:

(i) any item expressly deleted from the list of precursors in §13.116 [ ~~§13.115~~ ] of this title (relating to Additions and Deletions) after being determined by the director to no longer jeopardize public health and welfare by evidenced proliferation or use in clandestine laboratories or other illicit manufacturer of a controlled substance or controlled substance analogue; or

(ii) an immediate precursor under §13.117 [ ~~§13.116~~ ] of this title (relating to Immediate Precursor List ) .

(13) Recipient--A person who receives, orders, or otherwise seeks to receive a precursor or apparatus, whether through purchase, lease, loan, gift, or other transfer.

(14) Waiting period--The 21-day period required before a person may lawfully receive or deliver a precursor or apparatus under the Act, §481.077(f) or §481.080(g) [ ~~§481.080(h)~~ ].

(15) Immediate precursor--A chemical substance item listed in §13.117 [ ~~§13.116~~ ] of this title (relating to Immediate Precursor List).

(16) Wholesale distributor--A distributor who sells, transfers, or otherwise furnishes a product containing ephedrine, pseudoephedrine, or norpseudoephedrine to a retailer.

(17) Suspicious quantity order--The circumstances of the sale or transfer of a product containing ephedrine, pseudoephedrine, or norpseudoephedrine would lead a reasonable person to believe the substance is likely to be used for the purpose of unlawfully manufacturing a controlled substance due to any of the following:

(A) the method of payment;

(B) the method of requested delivery;

(D) the amount exceeds the threshold as set by the United States Drug Enforcement Administration; or

(E) any other circumstance that the wholesale distributor determines to be suspicious.

§13.103.Permit Exception.

The director declares by rule a person to be excepted from the permit requirements with respect to a precursor or apparatus covered by this subchapter, if the person:

(1) is excepted from the permit requirements under the Act, §481.0621 or §481.077(l);

(2) is a controlled substances registrant under the authority of the Act, §481.077(c) or §481.080(d) [ ~~§481.080(e)~~ ];

(3) - (10) (No change.)

§13.104.Requirements for Permit Issuance.

(a) One time. The director will issue a one-time permit to distribute or receive a stated precursor or apparatus to a person who:

(1) - (4) (No change.)

(5) delivers to the director an appropriate written consent described in §13.237 of this title (relating to Inspection of Permit Holder and Pseudoephedrine Records and Reports ).

(b) - (c) (No change.)

§13.107.Business Letter of Authorization.

(a) Permit alternative. In lieu of a permit authorizing immediate distribution, a legitimately established business may receive a precursor or apparatus from a distributor within this state after a 21-day waiting period by presenting or providing to the distributor a letter of authorization from the business.

(b) Contents. A letter of authorization from a business recipient must include:

(1) the information required under the Act, §481.077(d)(2)(A) or §481.080(e)(2)(A) [ ~~§481.080(f)(2)(A)~~ ];

(2) the precursor or apparatus sought;

(3) the name of business issuing the letter;

(4) the issue date of the letter;

(5) the mailing and physical address, including the number and street name, city, state, and zip code; and

(6) the signature of the individual executing the letter on behalf of the business.

(e) Expiration. A letter of authorization expires one year from the date [ ~~day~~ ] of issue.

(f) Retention. The distributor must retain the original letter of authorization on file and forward a copy of the letter, along with a [ ~~proposed~~ ] NAR-22 or other communication adequately detailing the proposed transaction, to the director (PCLAS). Until expiration, a distributor may use the original for future distributions. The recipient must issue a new letter:

(1) after the letter expires; or

(2) if material information required in the original letter changes.

§13.108.Waiting Period.

(a) - (b) (No change.)

(c) Permit alternative. A valid one-time or annual permit allows a distributor to complete the transaction before the required 21-day waiting period has elapsed, if:

(1) the prospective recipient presents proper identification to the distributor under §13.110 of this title (relating to NAR-22); and

(2) the permit contains no apparent alterations, if it is a one-time permit; or

(3) the recipient furnishes to the distributor the permit number, if it is an annual permit.

(d) (No change.)

§13.109.Reporting Distribution.

(a) Generally. Except as provided by this section, a distributor must use a NAR-22 to report to the director (PCLAS) each incident in which the distributor delivers a precursor or apparatus to a person located inside this state. A distributor, who is located in this state and who delivers a precursor or apparatus to a person located inside this state, must report the transaction to the director (PCLAS), whether or not the recipient holds a permit issued under this subchapter.

(b) Business without permit. A distributor, who seeks to deliver a precursor or apparatus to a legitimately established business, that does not have a permit and is not excepted from the permit requirements of the Act or this subchapter, must report the proposed transfer to the director. The report must include a copy of the letter of authorization, along with a [ ~~proposed~~ ] NAR-22 or other communication adequately detailing the proposed transaction, and must be transmitted to the director (PCLAS). The distributor may lawfully deliver the item only after observing the 21-day waiting period under §13.108 of this title (relating to Waiting Period).

§13.110.NAR-22.

(a) Generally. The NAR-22 contains information required from a distributor to describe the relevant details of the transaction, including information about a recipient of a precursor or apparatus.

(b) Format. The distributor must complete all applicable sections of the NAR-22 [ ~~in the manner described by the current copy of the DPS Pamphlet NAR-11d, that has been published by the director and made available to the public through the PCLAS~~ ].

§13.111.Exclusion.

This subchapter does not apply to the sale or transfer of any compound, mixture, or preparation containing ephedrine, pseudoephedrine, or norpseudoephedrine that is in liquid, liquid capsule, or liquid gel capsule form and is:

(1) mixed or combined with another noncontrolled chemical or substance in the manufacture of a substance;

(2) used for a legitimate purpose; and

(3) only reclaimable through a distillation or extraction process.

§13.112.Ephedrine, Pseudoephedrine, and Norpseudoephedrine.

(a) Generally. A wholesale distributor who sells, transfers, or otherwise furnishes a product containing ephedrine, pseudoephedrine, or norpseudoephedrine to a retailer shall obtain before delivering the product:

(1) the retailer's business name, address, area code, and telephone number;

(2) the name of the person making the purchase;

(3) the amount of the product containing ephedrine, pseudoephedrine, or norpseudoephedrine ordered; and

(4) any other information that may be required by the director.

(b) Record. A wholesale distributor shall make an accurate and legible record of the information in subsection (a) of this section and the amount of the product containing ephedrine, pseudoephedrine, or norpseudoephedrine actually delivered. A wholesale distributor shall retain the record for a period of at least two years after the date of the transaction. The record shall be made available to the director upon request.

(c) Suspicious Quantity Report. Not later than 10 business days after the receipt of an order for a product containing ephedrine, pseudoephedrine, or norpseudoephedrine that requests delivery of a suspicious quantity of that product, a wholesale distributor shall submit a NAR-91B (Report of Theft, Loss or Suspicious Order of Precursor Chemical/Laboratory Apparatus) to the director as a report of the suspicious order. The NAR-91B is available on the department website at www.txdps.state.tx.us.

(d) Failure to Report. A wholesale distributor who, with reckless disregard for the duty to report, fails to report as required by subsection (c) of this section shall be subject to disciplinary action to include:

(1) denial, suspension, or revocation of any permit or registration issued by the department;

(2) notification to the Texas Department of State Health Services; and

(3) notification to the United States Drug Enforcement Administration.

§13.113.Out-of-State Activity.

(a) Distributor. Except as required by this section, a distributor who is located outside this state may distribute without complying with this subchapter. A distributor who is located in this state must meet:

(1) the permit requirements of §13.102 of this title (relating to Who Must Obtain Permit); and

(2) the reporting requirements of §13.109 of this title (relating to Reporting Distribution).

(b) Recipient. If the recipient is located outside this state at the time of order and at the time of receipt, this subchapter does not apply and the distributor need not require a permit or a letter of authorization from the recipient.

§13.114.Security, Record Keeping, Inventory, Inspection, and Reporting Discrepancy, Loss, Theft, or Diversion.

A distributor, wholesale distributor, or recipient must comply with the applicable provisions of:

(1) Subchapter H of this chapter (relating to Security);

(2) Subchapter I of this chapter (relating to Record Keeping);

(3) Subchapter J of this chapter (relating to Inventory);

(4) Subchapter K of this chapter (relating to Inspection); and

(5) Subchapter L of this chapter (relating to Reporting Discrepancy, Loss, Theft, or Diversion).

§13.115.Communication with Director (PCLAS).

If a person is required or allowed by this subchapter to make a notification, report, or other written, telephonic, or personal communication to the director, the person must make the communication to the director through the PCLAS at the address indicated in §13.10 of this title (relating to Telephone Number and Address - Precursor Chemical/Laboratory Apparatus Section).

§13.116.Additions or Deletions.

(a) Generally. Under the authority of the Act, §481.077(b) and §481.080(c), the director may determine a precursor or apparatus should be added to or deleted from the precursor or apparatus lists.

(b) Precursor additions. The director has determined:

(1) each chemical precursor substance listed in this subsection does jeopardize public health and welfare and is proliferating or being used in clandestine laboratories or other illicit manufacture of a controlled substance or controlled substance analogue; and

(2) each of the following items are named to the list of chemical precursor substances subject to the Act, §481.077(b): red phosphorus and hypophosphorous acid.

(1) each chemical precursor substance listed in this subsection does not jeopardize public health and welfare and is not proliferating or being used in clandestine laboratories or other illicit manufacture of a controlled substance or controlled substance analogue; and

(2) each of the following items are deleted from the list of chemical precursor substances subject to the Act, §481.077(b): (none).

(d) Apparatus additions. The director has determined:

(1) each item of chemical laboratory apparatus listed in this subsection does jeopardize public health and welfare and is proliferating or being used in clandestine laboratories or other illicit manufacture of a controlled substance or controlled substance analogue; and

(2) each of the following items are named to the list of items of chemical laboratory apparatus subject to the Act, §481.080(a): (none).

(e) Apparatus deletions. The director has determined:

(1) each item of chemical laboratory apparatus listed in this subsection does not jeopardize public health and welfare and is not proliferating or being used in clandestine laboratories or other illicit manufacture of a controlled substance or controlled substance analogue; and

(2) each of the following items are deleted from the list of items of chemical laboratory apparatus subject to the Act, §481.080(a): (none).

§13.117.Immediate Precursor List.

The following substances are designated as being an immediate precursor as provided under the Act, §481.002(22):

(1) Benzaldehyde;

(2) Gamma-Butyrolactone (other names include: GBL; Dihydro-2(3H)-furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid lactone; gamma-hydroxybutyric acid lactone);

(3) Isosafrole;

(4) 3,4-Methylenedioxyphenyl-2propanone;

(5) N-Methylephedrine, its salts, optical isomers, and salts of optical isomers;

(6) N-Methylpseudoephedrine, its salts, optical isomers, and salts of optical isomers;

(7) Piperonal;

(8) Safrole; and

(9) Lithium metal removed from a battery and immersed in kerosene, mineral spirits, or similar liquid that prevents or retards hydration.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2007.

TRD-200702561

Thomas A. Davis, Jr.

Director

Texas Department of Public Safety

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 424-2135

37 TAC §§13.111 - 13.116

(Editor's note: The text of the following sections proposed for repeal will not be published. The sections may be examined in the offices of the Texas Department of Public Safety or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

The Texas Department of Public Safety proposes the repeal of §§13.111 - 13.116, concerning Precursors and Apparatus. Due to legislation from the 79th Regular Legislative Session in HB 164 regarding the distribution and retail of certain chemical substances, Texas Health and Safety Code, §481.077, was modified and Texas Health and Safety Code, §481.0771, was created. Based on the changes to law, it is necessary to propose revisions and additional clarification of current rules for permitting and reporting the distribution and sales of certain chemical substances. Therefore, it is necessary to repeal the current sections and simultaneously file new renumbered sections.

Oscar Ybarra, Chief of Finance, has determined that, for each year of the first five-year period the proposed repeals are in effect there will be no fiscal implications for state or local government, or local economies.

Mr. Ybarra also has determined that, for each year of the first five-year period the proposed repeals are in effect, the public benefit anticipated as a result of enforcing the repeals will be current and updated rules. There is no adverse economic impact anticipated for individuals, small businesses, or micro-businesses.

Comments on the repeals may be submitted to Johnny Hatcher, Narcotics Regulatory Programs, MSC 0433, Texas Department of Public Safety, P.O. Box 4087, Austin, Texas 78773-0433; or by electronic mail to johnny.hatcher@txdps.state.tx.us. The department will accept comments for 30 days after publication in the Texas Register . For further information, call Johnny Hatcher at (512) 424-2458.

The repeals are proposed pursuant to Texas Health and Safety Code, §§481.003, 481.077, and 481.0771, which authorizes the director to adopt rules to administer and enforce the Texas Controlled Substances Act.

Texas Health and Safety Code, §§481.003, 481.077, and 481.0771 are affected by this proposal.

§13.111.Mixed Precursor.

§13.112.Out-of-State Activity.

§13.113.Security, Record Keeping, Inventory, Inspection, and Reporting Discrepancy, Loss, Theft, or Diversion.

§13.114.Communication with Director (PCLAS).

§13.115.Additions or Deletions.

§13.116.Immediate Precursor List.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2007.

TRD-200702557

Thomas A. Davis, Jr.

Director

Texas Department of Public Safety

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 424-2135

Subchapter F. APPLICATION

37 TAC §§13.131 - 13.133, 13.137

The Texas Department of Public Safety proposes amendments to Chapter 13, §§13.131 - 13.133, and 13.137, concerning Controlled Substances Application. Due to legislation from the 79th Regular Legislative Session in HB 164, regarding the distribution and retail of certain chemical substances, Texas Health and Safety Code, §481.077 was modified and Texas Health and Safety Code, §481.0771 was created. Based on the changes to law, it is necessary to propose revisions and additional clarification of current rules for permitting and reporting the distribution and sales of certain chemical substances. Additional non-substantive changes have also been included to improve clarity, and to streamline and clarify procedures and terminology throughout the chapter.

Additional amendments to §13.132 are necessary in order to outline additional application requirements for mid-level practitioners, while additional amendments to §13.137 outline modification requirements for mid-level practitioners.

The amendments are proposed pursuant to Texas Health and Safety Code, §§481.003, 481.077, 481.0771, and 481.080, which authorizes the director to adopt rules to administer and enforce the Texas Controlled Substances Act.

Texas Health and Safety Code, §§481.003, 481.077, 481.0771, and 481.080 are affected by this proposal.

§13.131.Subchapter Definitions.

The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.

(1) Registrant--A person who holds a registration or permit covered by this chapter.

(2) Registration--A registration issued under this chapter, including a general controlled substances registration , [ or ] a specific peyote distributor registration , or [ ~~and~~ ] a precursor or apparatus permit issued under this chapter.

§13.132.Application Requirements.

(a) - (f) (No change.)

(g) Mid-level practitioners.

(1) each mid-level practitioner must have a supervisory physician delegating prescriptive authority as required by the Act, §481.002(39)(D). Each physician must certify the authorizing delegation on the mid-level practitioner's application and include the physician's:

(A) name;

(B) Texas Medical Board license number;

(D) signature; and

(E) date of signature.

(2) Effect of signature. A physician who signs a mid-level practitioner's application as the supervising physician assumes responsibility for ensuring that the mid-level practitioner practices under the laws of this state related to controlled substances prescribing activities. A physician who fails to properly monitor the mid-level practitioner's activities is subject to disciplinary action.

(3) Registration and License Status. A supervising physician must have an unrestricted and active DPS registration and Texas Medical Board license number.

(4) Change of Delegating Physician.

(A) A change of delegating physician must be submitted in writing as required in §13.208 of this title (relating to Requirements to Update Information).

(B) A delegating physician shall notify the director in writing to terminate delegation with a mid-level practitioner.

(5) Limitations. The physician is limited to the extent and number of mid-level practitioners that the physician delegated as outlined in Chapter 157, Occupations Code.

§13.133.Application Form and Content.

(a) - (b) (No change.)

(c) Renewal. The director will mail a form for an application for renewal to a registrant approximately 60 days before the expiration date of the registration to the address currently on file with the appropriate section of the Narcotics Service .

(d) - (e) (No change.)

§13.137.Modification.

(a) Availability. A registrant may apply to the director through the appropriate section of the Narcotics Service for registration modification to:

(1) authorize the addition or deletion of a schedule, precursor, or apparatus;

(2) change any information on the name line of the registration; [ or ]

(3) correct, at the discretion of the director, other information on the registration certificate or permit document ; or [ . ]

(4) change a supervising physician delegating prescriptive authority to include the physician's:

(A) name;

(B) Texas Medical Board license number;

(D) signature; and

(E) date of signature.

(b) Written request. A person must notify the director in writing of the modification sought, including the signature of the registrant or other person who is authorized to sign an original application under §13.132(d) or (e) of this title (relating to Application Requirements) .

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2007.

TRD-200702562

Thomas A. Davis, Jr.

Director

Texas Department of Public Safety

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 424-2135

Subchapter G. FORFEITURE AND DESTRUCTION

37 TAC §13.155, §13.158

The Texas Department of Public Safety proposes amendments to Chapter 13, §13.155 and §13.158, concerning Forfeiture And Destruction. The proposed amendment to §13.155 deletes reference to repealed Chapter 484, Texas Health and Safety Code. The proposed amendment to §13.158(a)(3) updates the state agency name.

Comments on the proposal may be submitted to Johnny Hatcher or Narcotics Regulatory Programs, MSC 0433, Texas Department of Public Safety, P.O. Box 4087, Austin, Texas 78773-0433; or by electronic mail to johnny.hatcher@txdps.state.tx.us. The department will accept comments for 30 days after publication in the Texas Register . For further information, call Johnny Hatcher at (512) 424-2458.

The amendments are proposed pursuant to Texas Health and Safety Code, §481.003, which authorizes the director to adopt rules to administer and enforce the Texas Controlled Substances Act.

Texas Health and Safety Code, §481.003, is affected by this proposal.

§13.155.Destruction Authority- Other Item.

(a) Destruction with or without court order. A laboratory, law enforcement agency, or peace officer may destroy certain miscellaneous items covered by this section:

(1) with a court order under the authority of that order; or

(2) without a court order under the authority of one of the summary destruction provisions of the Texas Health and Safety Code, Chapters 482 - 485.

(b) Statutory sources. A laboratory, law enforcement agency, or peace officer may destroy without a court order:

(1) a simulated controlled substance under the authority of the Texas Health and Safety Code, §482.004; or

(2) [ ~~a volatile chemical or related inhalant paraphernalia under the authority of the Texas Health and Safety Code, §484.007; or~~ ]

[ ~~(3)~~ ] an abusable volatile chemical [ ~~glue, aerosol paint,~~ ] or [ ~~related~~ ] inhalant paraphernalia under the authority of the Texas Health and Safety Code, §485.037 [ ~~§485.038~~ ].

(c) Dangerous drug. At the direction of the Texas State Board of Pharmacy, a law enforcement agency or peace officer may destroy without a court order a dangerous drug under the authority of the Texas Health and Safety Code, §483.074.

(d) Subchapter applies. The documentation and security provisions of this subchapter apply to destruction of a miscellaneous item under this section, except where provided otherwise in a court order of destruction.

§13.158.Manner of Destruction- Security Control.

(a) Destruction by anyone. A person may accomplish routine destruction of an item under this subchapter by burning in a suitable incinerator or by another method as long as the person performs the destruction in:

(1) a safe and responsible manner;

(2) compliance with all relevant federal, state, and local laws; and

(3) compliance with all requirements of the Texas [ ~~Natural Resources Conservation~~ ] Commission on Environmental Quality and the EPA.

(b) Private contract. If a laboratory, law enforcement agency, or peace officer contracts with a private entity to destroy the item, the private contractor must:

(1) hold a controlled substances registration number from the director and DEA; and

(2) obtain full permitting from the EPA as a hazardous waste transportation, storage, or disposal facility, as appropriate.

(c) Destruction by officer. The director recommends but does not require that an individual peace officer should not destroy hazardous material, unless that officer possesses the special expertise required to handle the material safely and lawfully.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2007.

TRD-200702563

Thomas A. Davis, Jr.

Director

Texas Department of Public Safety

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 424-2135

Subchapter H. SECURITY

37 TAC §§13.184 - 13.186

The Texas Department of Public Safety (department) proposes amendments to Chapter 13, §§13.184 - 13.186, concerning Security. Proposed amendments to §13.184 are necessary in order to correct a grammatical error in subsection (a)(4) and to correct a reference to statute. Proposed amendments to §13.185 are necessary in order to state an additional prohibited act regarding the Official Prescription Form and specify allowable forms and criteria for faxed forms. The proposed amendment to §13.186 is necessary in order to update a statutory reference in subsection (a)(1).

The amendments are proposed pursuant to Texas Health and Safety Code, §481.003, which authorizes the director to adopt rules to administer and enforce the Texas Controlled Substances Act.

Texas Health and Safety Code, §481.003, is affected by this proposal.

§13.184.Registrant's Employee.

(a) Disqualification. A registrant may not intentionally, knowingly, or recklessly employ or use in any manner an individual who will or is reasonably likely to have access to a controlled substance and who:

(1) has had a federal or state application for controlled substances registration denied, revoked, canceled, or suspended;

(2) has been convicted of a felony offense under a state or federal law;

(3) does not comply with a federal security control for a practitioner under the Code of Federal Regulations, Title 21, Chapter II, §1301.76;

(4) does not meet a federal employee screening standard for a non-practitioner under [ of ] the Code of Federal Regulations, Title 21, Chapter II, §§1301.90 - 1301.93 [ ~~§§1301.90 - 301.93~~ ]; or

(5) has had a license revoked, canceled, or suspended by a state health regulatory agency.

(b) Disqualification waived. After considering the registrant's written request, the director may allow the registrant to employ an individual who has violated subsection (a) of this section. The director may not waive the requirements that a registrant not hire an individual during the two-year period immediately following the individual's conviction for a felony offense under state or federal law or until the terms of a sentence are satisfied, whichever is the longer period of time.

(c) Factors. Before making a waiver decision, the director may consider each relevant factor, including, but not limited to, the following:

(1) if the individual is a convicted felon, the suspension of sentence, placement of the individual on probation, and the successful completion by the individual of a court-ordered supervision;

(2) whether the health regulatory agency has reinstated or reissued the previously revoked, canceled, or suspended license of the individual; and

(3) whether the employment of that individual by a registrant is in the best interest of the public and the individual.

§13.185.Official Prescription Form.

(a) Accountability. A practitioner who obtains from the director an official prescription form is accountable for each numbered form.

(b) Prohibited acts. A practitioner may not:

(1) allow another practitioner to use the individual practitioner's official prescription form;

(2) pre-sign an official prescription blank; [ or ]

(3) post-date an official prescription; or

(4) [ ~~(3)~~ ] leave an official prescription blank in a location where the practitioner should reasonably believe another could steal or misuse a prescription.

(c) While not in use. While an official prescription blank is not in immediate use, a practitioner may not maintain or store the book at a location so the book is easily accessible for theft or other misuse.

(d) Voided. A practitioner must account for each voided official prescription form by sending the voided form to the director (Texas Prescription Program).

(e) Types of forms. Forms may be single or multiple copy forms as provided by the department.

(f) Faxed forms. Faxed official prescription forms will be accounted for as in the Act, §481.074(o).

§13.186.Precursor or Laboratory Apparatus.

(a) Required unless one-time permit. A distributor or recipient of a precursor or apparatus must comply with this subsection:

(1) unless the person is exempted or excepted from similar security requirements by this chapter or the Act, §481.077(k) or §481.080(l) [ ~~§481.080(m)~~ ] as a one-time permit holder; or

(2) even though the person is exempted or excepted as described in paragraph (1) of this subsection, the person has voluntarily submitted to annual permitting under this chapter.

(b) Storage requirements. A business, distributor, or individual who holds a precursor chemical or laboratory apparatus permit will meet the following minimum security requirements to protect these controlled items. The permit holder will:

(1) establish and maintain a building, an enclosure within a building, or an enclosed yard that provides reasonably adequate security against the diversion of a controlled item;

(2) limit access to each storage area to the minimum number of individuals or employees necessary for the permit holder's activities; and

(3) designate an individual or a reasonably limited set of individuals with:

(A) responsibility for each area where a controlled item is stored; and

(B) authority to enter or control entry into the area.

(c) No physical barrier. In the absence of a physical barrier, such as a wall, partition, fence, or similar divider, the permit holder may comply with this section by another form of substantially increased security to limit physical access to the storage area under subsection (b)(2) of this section.

(d) Written designation. The permit holder will make the designation required by subsection (b)(3) of this section in writing and will make the designation available upon request in the same manner as a record kept under this chapter. The holder may update the designation record as necessary to reflect current practice.

(e) Observation. When maintenance personnel or a business guest, visitor, or similar individual is present in or passes through, an area covered by this section, the permit holder must provide for reasonably adequate observation of the area by an employee specifically designated under subsection (b)(3) of this section.

(f) Alarm system. If a permit holder has an alarm system that is in operation and being monitored, the permit holder must immediately report each unauthorized intrusion or other security breach to:

(1) a local law enforcement agency; or

(2) the director (PCLAS).

(g) No risk of diversion. A permit holder is not required to make the alarm report required under subsection (f) of this section, if there is a clearly innocent or other reasonable explanation for the security breach that does not involve a potential of diversion.

(h) Limited risk of diversion. The director may waive a security requirement of this section if a permit holder or applicant demonstrates that business procedures or other circumstances impose a more strict security requirement that indicates a significantly limited risk of diversion.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2007.

TRD-200702564

Thomas A. Davis, Jr.

Director

Texas Department of Public Safety

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 424-2135

Subchapter I. RECORD KEEPING

37 TAC §§13.205 - 13.208

The Texas Department of Public Safety proposes amendments to Chapter 13, §§13.205 - 13.208, concerning Record Keeping. Amendments to the sections are necessary in order to correct grammatical errors, to improve clarity and to include additional requirements to update information.

The amendments are proposed pursuant to Texas Health and Safety Code, §481.003, which authorizes the director to adopt rules to administer and enforce the Texas Controlled Substances Act; and §481.080(l), which provides that a person covered by this subsection shall maintain records and inventories in accordance with rules established by the director.

Texas Health and Safety Code, §481.003 and §481.080, are affected by this proposal.

§13.205.Practitioner's Designated Agent.

(a) - (d) (No change.)

(e) List provided. When a practitioner adds an individual to or deletes an individual from the list, the practitioner must provide upon request the current list to a pharmacy or pharmacist, the director, a member of the department, or an investigator listed in the Act, §481.076(a)(1).

§13.206.Precursor/Apparatus Records.

(a) Required unless one-time permit. A distributor or recipient of a precursor or apparatus must maintain records under this section:

(1) unless the person is exempted or excepted from reporting by this chapter or the Act, §481.077(k) or §481.080(l) [ ~~§481.080(m)~~ ] as a one-time permit holder; or

(2) even though the person is exempted or excepted as described in paragraph (1) of this subsection, the person has voluntarily submitted to annual permitting under this chapter.

(b) Distributor. A distributor of a precursor or apparatus must:

(1) make an accurate and legible record of a distribution; and

(2) maintain the record after the date of the transaction.

(c) NAR-22. Copy 2 of a properly completed DPS Form NAR-22 meets the record keeping requirement of this section while it remains in the distributor's record booklet [ Proper completion of the DPS Form NAR-22 automatically generates the record of distribution on its Copy 2, that meets the record keeping requirement under this section while it remains in the distributor's record booklet ].

(d) - (g) (No change.)

§13.207.Record Retention Period.

(a) Two years, generally. Except as otherwise provided by law or this chapter, a record required to be made or kept by the Act or this chapter must be kept, maintained, and made available for inspection or copying for a period of two years.

(b) Beginning date. The two-year period described by this section commences on the later date of the day:

(1) the record was required to be created;

(2) the record was actually created; or

(3) the prescription was last filled [ ~~refilled~~ ].

§13.208.Requirement to Update Information.

A person, who is an applicant for or holder of a registration or annual permit from the director, must notify the director through the appropriate section of the Narcotics Service before the seventh day after any change in the person's business name, address, physician delegating prescriptive authority, and telephone number or other information required on the application, registration, or permit.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2007.

TRD-200702565

Thomas A. Davis, Jr.

Director

Texas Department of Public Safety

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 424-2135

Subchapter J. INVENTORY

37 TAC §13.223

The Texas Department of Public Safety proposes an amendment to Chapter 13, §13.223, concerning Inventory. An amendment to §13.223 is necessary in order to correct a statutory reference.

Oscar Ybarra, Chief of Finance, has determined that for each year of the first five-year period the rule is in effect there will be no fiscal implications for state or local government, or local economies.

Mr. Ybarra also has determined that for each year of the first five-year period the rule is in effect the public benefit anticipated as a result of enforcing the rule will be current and updated rules. There is no adverse economic impact anticipated for individuals, small businesses, or micro-businesses.

The department has determined that Chapter 2007 of the Government Code does not apply to this rule. Accordingly, the department is not required to complete a takings impact assessment regarding this rule.

The amendment is proposed pursuant to Texas Health and Safety Code, §481.003 and §481.080, which authorizes the director to adopt rules to administer and enforce the Texas Controlled Substances Act.

Texas Health and Safety Code, §481.003 and §481.080 are affected by this proposal.

§13.223.Precursor/Apparatus Inventory.

(a) Required unless one-time permit. A distributor or recipient of a precursor or apparatus must establish and maintain an inventory under this section:

(1) unless the person is exempted or excepted from inventory requirements by this chapter or the Act, §481.077(k) or §481.080(l) [ ~~§481.080(m)~~ ] as a one-time permit holder; or

(2) even though the person is exempted or excepted as described in paragraph (1) of this subsection, the person has voluntarily submitted to annual permitting under this chapter.

(b) - (f) (No change.)

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2007.

TRD-200702566

Thomas A. Davis, Jr.

Director

Texas Department of Public Safety

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 424-2135

Subchapter K. INSPECTION

37 TAC §13.233, §13.237

The Texas Department of Public Safety proposes amendments to Chapter 13, §13.233 and §13.237, concerning Inspection. Amendment to §13.233 includes a non-substantive grammatical change and is necessary in order to improve clarity to the section. Amendments to §13.237 are necessary in order to change the name of the section and add new subsection (d) listing the requirements for records and reports of purchases and sales of ephedrine, pseudoephedrine, and norpseudoephedrine.

Comments on the proposal may be submitted to Johnny Hatcher, Narcotics Regulatory Programs, MSC 0433, Texas Department of Public Safety, P.O. Box 4087, Austin, Texas 78773-0433; or by electronic mail to johnny.hatcher@txdps.state.tx.us. The department will accept comments for 30 days after publication in the Texas Register. For further information, call Johnny Hatcher at (512) 424-2458.

Texas Health and Safety Code, §§481.003, 481.077, 481.0771, and 481.080, are affected by this proposal.

§13.233.Who May Inspect.

(a) Generally. This subchapter applies to the director's authority under the Act to enter and inspect [ a ] controlled premises [ ~~premise~~ ]. While engaged in the inspection or an activity reasonably related to the inspection, the director may examine, audit, inventory, or, as appropriate, copy an item or record found on the premises.

(b) Delegation. The director delegates authority described in subsection (a) of this section to each member of the department who is assigned to the Narcotics Service, whether or not the member is a commissioned peace officer.

(c) Assistance. When exercising an authority described in subsections (a) or (b) of this section, the director or member may be assisted by:

(1) a peace officer;

(2) another member of the department;

(3) a member of DEA;

(4) an investigator listed in the Act, §481.076(a)(1);

(5) a representative of an appropriate state health regulatory agency governing the conduct of a registrant; or

(6) another individual acting under the authority of the director or member.

§13.237.Inspection of Permit Holder and Pseudoephedrine Records and Reports .

(a) Generally. The holder of a [ ~~one-time~~ ] permit for distribution or receipt of a chemical precursor or laboratory apparatus may be inspected subject to the limitations of the Act, §481.077(k) , [ ~~and~~ ] § 481.080(l) [ ~~481.080(m)~~ ] and §13.104 of this title (relating to Requirements for Permit Issuance).

(b) Consent to inspect - one-time. An applicant for a one-time permit must give written consent for one or more pre-permit inspections under this subchapter to determine eligibility for issuance of the permit. A written consent to an inspection under the Act, §481.078(e) or §481.081(e), is sufficient for a one-time permit if the consent is for initial inspection or any additional inspection to be conducted before issuance of the permit and at a reasonable time as necessary to determine qualification for the permit.

(c) Consent to inspect - annual. A written consent given by a person seeking an annual permit must include consent for an initial inspection to determine qualification for the permit sought and additional inspections conducted before or after issuance of the permit at a reasonable time as necessary to enforce the Act or this chapter.

(d) Pseudoephedrine Records and Reports.

(1) Generally. A wholesale distributor who distributes a product containing ephedrine, pseudoephedrine, or norpseudoephedrine to a retailer shall make available for immediate inspection to any member of the department during regular business hours upon presentation of proper credentials all files, papers, processes, controls, or facilities appropriate for verification of a required record or report. If the wholesaler is no longer in operation or closed, the records shall be made available within three (3) business days.

(2) Delegation. The director delegates authority described in this section to each member of the department who is assigned to the Narcotics Service, whether or not the member is a commissioned peace officer.

(3) Assistance. When exercising the authority in this section, a member of the department may be assisted by:

(A) a peace officer;

(B) another member of the department;

(D) a representative of an appropriate state health regulatory agency governing the conduct of a wholesaler; or

(E) another individual acting under the authority of the director or member.

(e) [ ~~(d)~~ ] Statutory authority. A member of the department or peace officer is expressly authorized by the Act, §481.077(k) and § 481.080(l) [ ~~481.080(m)~~ ], to audit, inspect, and copy a record of a purchase or sale of a precursor or apparatus of a person who holds an annual permit under Subchapter E of this chapter (relating to Precursors and Apparatus). Except as provided by subsection (b) of this section, this section does not apply to a person who holds a one-time permit.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2007.

TRD-200702567

Thomas A. Davis, Jr.

Director

Texas Department of Public Safety

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 424-2135

Subchapter L. REPORTING DISCREPANCY, LOSS, THEFT, OR DIVERSION

37 TAC §13.252, §13.253

The Texas Department of Public Safety proposes amendments to Chapter 13, §13.252 and §13.253, concerning Reporting, Discrepancy, Loss, Theft, or Diversion. Amendments to the sections include non-substantive grammatical changes and are necessary in order to improve clarity to the sections.

Comments on the proposal may be submitted to Johnny Hatcher, Narcotics Regulatory Programs, MSC 0433, Texas Department of Public Safety, P.O. Box 4087, Austin, Texas 78773-0433; or by electronic mail to johnny.hatcher@txdps.state.tx.us. The department will accept comments for 30 days after publication in the Texas Register. For further information, call Johnny Hatcher at (512) 424-2458.

The amendments are proposed pursuant to Texas Health and Safety Code, §481.003, which authorizes the director to adopt rules to administer and enforce the Texas Controlled Substances Act.

Texas Health and Safety Code, §481.003 is affected by this proposal.

§13.252.Applicability.

(a) Discrepancy [ ~~To discrepancy~~ ], loss, theft, or other potential diversion. Without regard to actual evidence of diversion, this subchapter applies to a discrepancy, loss, or theft of a controlled or other regulated item or substance or other situation involving a potential for diversion.

(b) Who must report. This subchapter applies to a person who is:

(1) a registrant under Subchapter B of this chapter (relating to Registration);

(2) a registered peyote distributor under Subchapter C of this chapter (relating to Peyote); or

(3) a precursor or apparatus permit holder under Subchapter E of this chapter (relating to Precursors and Apparatus), whether it is a one-time or annual permit.

§13.253.Reporting Discrepancy, Loss, Theft, or Other Potential Diversion.

(a) Generally. A person covered by this subchapter must notify the director not later than the third day after the date the person learns of:

(1) a discrepancy in the amount of an item ordered from a source inside or outside this state and the amount received, if not back ordered;

(2) a loss or theft during shipment from a source inside or outside this state; or

(3) a loss or theft from current inventory.

(b) How made. A person covered by this subchapter must notify the director by submitting a report to the director through the appropriate section of the Narcotics Service. The report must be made on:

(1) a DPS Form NAR-91, for a registrant under Subchapter B of this chapter (relating to Registration) or Subchapter C of this chapter (relating to Peyote);

(2) a DPS Form NAR-91B, for a precursor or apparatus permit holder under Subchapter E of this chapter (relating to Precursors and Apparatus); or

(3) a duplicate of the equivalent DEA form for reporting a theft or loss of a controlled substance to DEA.

(1) make the report on regular business letterhead or other reporting form; and

(2) ensure the report contains the following information:

(A) the name, address, and telephone number of the business or other person preparing the report;

(B) the printed or typed name of the individual preparing the report; and

(d) Additional content. If the report under this section is of:

(1) a discrepancy, it must include:

(A) the name of the item ordered;

(B) the difference in the amount actually received; and

(2) a loss or theft from current inventory, it must include:

(A) the name and amount of the item lost or stolen;

(B) the physical location where the loss or theft occurred; and

(3) a discrepancy, loss, theft, or other potential diversion that occurred during shipment of the item, it must include:

(A) the name of the common carrier or person who transported the item; and

(B) the date the item was shipped.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2007.

TRD-200702568

Thomas A. Davis, Jr.

Director

Texas Department of Public Safety

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 424-2135

Subchapter M. DENIAL, REVOCATION, AND RELATED DISCIPLINARY ACTION

37 TAC §13.271, §13.272

The Texas Department of Public Safety proposes amendments to Chapter 13, §13.271 and §13.272, concerning Denial, Revocation, And Related Disciplinary Action. Amendments to the section include non-substantive grammatical changes and are necessary in order to improve clarity to the section.

Mr. Ybarra also has determined that for each year of the first five-year period the rules are in effect the public benefit anticipated as a result of enforcing the rule will be current and updated rules. There is no adverse economic impact anticipated for individuals, small businesses, or micro-businesses.

The amendments are proposed pursuant to Texas Health and Safety Code, §481.003, which authorizes the director to adopt rules to administer and enforce the Texas Controlled Substances Act.

Texas Health and Safety Code, §481.003 is affected by this proposal.

§13.271.Subchapter Definitions.

The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.

(1) APA-- The [ ~~the~~ ] Administrative Procedure Act (Texas Government Code, Chapter 2001).

(2) Applicant-- Person [ ~~person~~ ] who applies for a registration or permit.

(3) Denial--Includes an action to deny an application for an original or renewal of a registration or permit.

(4) Disciplinary action--An action taken under this subchapter to accept a voluntary surrender or to reprimand, cancel, suspend, probate, revoke, or demonstrate expiration or termination of a current or former registration.

(5) Registrant--A person who holds a current or former registration or permit.

(6) Registration--A controlled substances registration, including a peyote distributor registration or a precursor or apparatus permit issued under this chapter.

(7) Serious misdemeanor--A Class A misdemeanor, a Class B misdemeanor, or another criminal offense punishable under the laws of this state, another state, or the United States by:

(A) confinement in a county jail or analogous penal institution; or

(B) a term of confinement of one year or less, if the jurisdiction does not differentiate between the location of felony or misdemeanor confinement.

§13.272.General Provisions.

(a) APA applies. Except as provided by this chapter, the APA applies if the director proposes to take disciplinary action against a person's registration or to deny a person's application for registration.

(1) The person is entitled to preliminary notice from the director and a hearing as a contested case under the APA.

(2) The director will send notice by certified mail or personal delivery [ ~~personally delivered~~ ] to the most current address of the registrant or applicant contained in the director's files. If mailed, the notice is presumed to have been received by the registrant or applicant on the third business day after the date of mailing.

(b) Pleadings. If the director pleads appropriately:

(1) the director may take a disciplinary action or make a denial under this subchapter against a chemical precursor or laboratory apparatus permit in the same manner as a disciplinary action or denial against a controlled substances registration; and

(2) a successful disciplinary action or denial by the director will also operate against any other registration issued by the director under this chapter.

(c) Action may be limited. The director may limit a disciplinary action or denial to the particular activity, schedule, controlled substance within a schedule, precursor, apparatus, or other item for which grounds for the action exist [ ~~exists~~ ].

(d) Notification of another agency. The director will promptly notify each appropriate federal or state health regulatory agency of an order taking a disciplinary action or denial against a registration or application, other than a permit issued under Subchapter E of this chapter (relating to Precursors and Apparatus).

(e) Invalidation. A registration may:

(1) expire or terminate;

(2) be canceled, surrendered, suspended, revoked, or otherwise invalidated; or

(3) be subject to reprimand or probation.

(f) Possession. Mere possession of the physical document does not necessarily mean that the person:

(1) still holds a current, valid registration; or

(2) currently holds, has ever held, or has any of the powers or rights indicated on the document.

(g) Hearing, evidence and procedure. Except as provided by this chapter, a hearing will be governed by the APA and will be held by an administrative law judge appointed by the State Office of Administrative Hearings. A hearing will be conducted in accordance with the procedures contained in Chapter 29 of this title (relating to Practice and Procedure), and the rules of the State Office of Administrative Hearings.

(h) Under the Act, §481.063(h), the APA does not apply to a denial, suspension, or revocation of an application for registration if the denial is based on a denial or other disciplinary action taken by DEA under the Federal Controlled Substances Act.

(i) Request for Hearing. An applicant or registrant may request a hearing under this subchapter by submitting a timely and properly addressed written request for a hearing to the director. To be timely, the request must be received by the director no later than fifteen calendar days after the date of the registrant's or applicant's receipt of the notice of denial or other disciplinary action. To be properly addressed, a request for hearing must be mailed or sent by e-mail or facsimile to the director at the return address included in the director's notice of denial or other disciplinary action or, if none, to the director at the address of the Narcotics Service indicated in §13.7 of this title (relating to Telephone Number and Address - Narcotics Service).

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 20, 2007.

TRD-200702569

Thomas A. Davis, Jr.

Director

Texas Department of Public Safety

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 424-2135

Part 7. TEXAS COMMISSION ON LAW ENFORCEMENT OFFICER STANDARDS AND EDUCATION

Chapter 221. PROFICIENCY CERTIFICATES AND OTHER POST-BASIC LICENSES

37 TAC §221.13

The Texas Commission on Law Enforcement Officer Standards and Education (Commission) proposes an amendment to Title 37, Texas Administrative Code, by amending §221.13. Subsections (a) - (c) are amended to require TDD/TTY training within the previous six months to qualify for basic, intermediate, or advanced proficiency certificates. Subsection (d) is amended to reflect the effective date for these changes.

The Commission has determined that, for each year of the first five years the section as proposed will be in effect, there will not be fiscal implications to state or local governments as a result of administering the section.

The Commission has determined that, for each year of the first five years the section as proposed will be in effect, there will be no anticipated economic cost to large, small, or micro businesses as a result of the proposed amendments.

The Commission has determined that, for each year of the first five years the section as proposed will be in effect, there will be a positive benefit to the hearing impaired public by ensuring that all emergency telecommunication operators are in compliance with mandated TDD/TTY requirements as set out in federal regulations, allowing individuals to meet or exceed the minimum standards established by the Commission to receive this proficiency certificate. Since proposed changes to this rule are the result of current required training, there is no increase in costs to affected agencies.

The Commission has determined that, for each year of the first five years the section as proposed will be in effect, there will be no additional cost to individuals required to comply with the rules as proposed.

Comments may be submitted in writing to Mr. Timothy A. Braaten, Executive Director, Texas Commission on Law Enforcement Officer Standards and Education, 6330 U.S. 290 East, Suite 200, Austin, Texas 78723.

This section is proposed for amendment under Texas Occupations Code, Chapter 1701, §1701.151, General Powers of Commission; Rulemaking Authority, which authorizes the Commission to promulgate rules for administration of this chapter.

The rule amendment as proposed is in compliance with the Texas Occupations Code, §1701.404, Telecommunicators.

No other code, article, or statute is affected by this proposal.

§221.13.Emergency Telecommunications Proficiency.

(a) To qualify for a basic telecommunications proficiency certificate, an applicant must meet all proficiency requirements:

(1) successful completion of a 40-hour course developed or approved by the commission;

(2) successful completion of a departmental field training course;

(3) successful completion of TDD/TTY training within the last six (6) months; and

(4) [ ~~(3)~~ ] one year of experience in public safety telecommunications.

(b) To qualify for an intermediate telecommunications proficiency certificate, an applicant must meet all proficiency requirements including:

(1) basic telecommunications certification;

(2) at least two years experience in public safety telecommunications;

(3) 120 hours of training; and

(4) successful completion of TDD/TTY training within the last six (6) months; and

(5) [ ~~(4)~~ ] if the basic telecommunications certificate was issued or qualified for on or after January 1, 2000, successful completion of required courses as specified by the commission, which include:

(A) Cultural Diversity;

(B) Ethics for Law Enforcement;

(D) TCIC/NCIC for Full Access Operators; NLETS/TLETS; or Criminal Law; and

(E) Spanish for Law Enforcement.

(c) To qualify for an advanced telecommunications proficiency certificate, an applicant must meet all proficiency requirements including:

(1) intermediate telecommunications certificate;

(2) at least four years experience in public safety telecommunications; and

(3) 240 training hours ; and [ . ]

(4) successful completion on TDD/TTY training within the last six (6) months.

(d) The effective date of this section is December 1, 2007. [ ~~June 1, 2004.~~ ]

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 19, 2007

TRD-200702527

Timothy A. Braaten

Executive Director

Texas Commission on Law Enforcement Officer Standards and Education

Earliest possible date of adoption: August 5, 2007

For further information, please call: (512) 936-7717