Resources for Drug Law


Table of Contents


Category 1-Orientation to the Legal Process

Texas Legal Process Map.

TexasProcessThumb.gif (1292 bytes)

   Information about laws or rules governing medicine, dentistry, etc and prescription writing can be found in the Texas Law.  Much of the law is now available through the internet.  By clicking on the thumbnail image above you go to a  flowchart that represents the relationship between the various sources of information available.  New legislation under consideration can be found by clicking Texas State Legislation in the hyperlinked map.  Once a bill is passed, it will be added to the Statutory Law which can be found in Vernon's Civil Statutes or one of the Texas Codes.  The Civil Statutes are presently being "codified" into codes, e.g. Government Code, Education Code, etc..  Once the law is made, it is administered by various state agencies.  Rules and regulations are developed by the state agencies from the laws.  The licensing boards are hotlinked to the state agencies box.  These rules are first announced in the Texas Register published by the Secretary of State.  The after being proposed, and if there are no substantial problems identified through public hearings, then the proposed rules will be "adopted".  The collected adopted rules can be found in the Texas Administrative Code (TAC).

Federal Legal Process Map Process for Drug Development
(Drug Marketing Classes)
fedprocessThumb.gif (1010 bytes) This is a hyperlinked map that shows the relationship between the federal agencies involved in drug development.

    Information about federal laws related to drugs and drugs of abuse.   Click on the thumbnail figure above and you will see a flowchart representing the flow of work through the federal legal process.  Each box can be clicked on to take you to additional information resources at the federal level.  In the case of the federal government most of this information is supplied by the National Archives and Records Administration.  There are specific links to relevant federal agencies, the Food and Drug Administration, the Drug Enforcement Agency and the Patent Office.

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Category 2-Texas Medical Law Summary

The legislature passes Practice Acts, which establish a Board, which implements necessary rules.
Rules for Boards are found in the Texas Administrative Code, Title 22, Examining Boards

Practice Act Authorized Board Rules and Regulations

Physicians Medical Practice Act
Texas Occupations Code
Title 3, Subtitle B,
Chapters 151-165

State Board of Medical Examiners Rules
Part IX
Chpts 161-199

Physicians Assistants
Texas Occupations Code
Title 3, Subtitle B,
Chapters 204

Texas State Board of Physician Assistant Examiners.
Rules Applying

Dental Practice Act
Texas Occupations Code,
Title 3, Subtitle D
Chapters 251-266

State Board of Dental
Examiners
Dental Licensure Rules
Part V
Chpts 101-125

Pharmacy Practice Act
Texas Occupations Code
Title 3, Subtitle J
Chapters 551-566,568,9

Texas State Board
of Pharmacy
Rules and Regulations
Title 22, Part XV
Chpts 281-311

Nursing Practice Act
Texas Occupations Code
Title 3, Subtitle
Chapters 301,303

Board of Nurse Examiners Rules and Regulations
Part XI
Chpts211-225

Other Practice Acts
Texas Occupations Code

Other Boards

Other Rules and Regulations
Texas Administrative Code
Title 22 Examining Boards

Table Notes

Useful links

Vernon's Texas Civil Statutes Title 71, Health, Public.
Texas Health and Safety Code (HSC)

Sections for Health and Safety Act

§ 481.071. Medical Purpose Required Before Prescribing, Dispensing,
§ 481.072. Medical Purpose Required Before Distributing or
§ 481.073. Communication of Prescriptions by Agent
§ 481.074. Prescriptions
§ 481.075. Official Prescription Program
§ 481.076. Official Prescription Information

Texas State Controlled Substance Regulations

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Category 3-Federal Agencies-FDA and DEA

Federal Information Resources

Food and Drug Administration

Federal Controlled Substances Regulations

Drug Enforcement Agency Home Page

 Drug Enforcement Administration Rules,  See Code of Federal Regulations Title 21, Vol 9, 1300

Patent and Trademark Office

USP-recognized as a quasilegal drug athority

USAN Council -I. Develop Generic Names for Drugs
USP Dictionary of USAN and International Drug Names-For purchase, if you want to be an expert!

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Category 5-Rules for Advanced Nurse Practitioners

Advanced Practice Nurse- may prescribe dangerous drugs under a physicians protocol or order in a particular place under particular kinds of supervision.

The APN carries out or signs prescription drug orders under physician supervision which consists of the following and the additional supervision requirements set out in Board of Medical Examiners (BME) Rule 193.8  (relating to Delegation of the Carrying Out or Signing of Prescription Drug Orders to Physician Assistants and Advanced Practice Nurses):

(A) at a site serving medically underserved populations, the physician visits the site at least once every ten business days during which the APN is on site providing care; the physician receives daily reports from the APN regarding complications encountered; and the physician is available for consultation by direct telecommunications; (11/98)

(B) at a physician's primary practice site, the physician is limited to delegation to three full time equivalent APNs; the physician may delegate the carrying out or signing of a prescription drug order for patients with whom the physician has established or will establish a physician-patient relationship but no time period to establish this relationship is required;

(C) at a facility-based practice, where the delegating physician is the medical director, chief of staff, credentialing committee chair, department chair or physician who consents to a request by the medical director or chief of staff; protocols or other orders must be developed in accordance with policies approved by the medical staff; the APN writing prescriptions for patients of physicians, other than the delegating physician, must have the approval of the patient's physician; delegation in long term care facilities is limited to three full time equivalent APNs; and the physician must have the approval of the BME to delegate at more than one licensed hospital or more than two long term care facilities.

  Other professionals who prescribe

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Other Vahn Lewis
Copyright © 1998 UTDB. All rights reserved.
Revised: April 18, 2001.