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Chapter 1: Overview of Texas Pharmacy Law

1 Contact Hour (Mandatory)

By Katie Ingersoll, RPh, PharmD, and Staff Pharmacist for a national chain.

Author Disclosure: Katie Ingersoll and Elite Professional Education, LLC do not have any actual or potential conflicts of interest in relation to this lesson.

Universal Activity Number (UAN): 0761-9999-13-278-H03-PActivity Type: Knowledge-basedInitial Release Date: August 12, 2013Expiration Date: August 12, 2015Target Audience: Pharmacist in a community-based setting.To Obtain Credit: A minimum test score of 70 percent is needed to obtain a credit. Please submit your answers either by mail, fax, or online at Pharmacy.EliteCME.com.

Questions regarding statements of credit and other customer service issues should be directed to 1-888-666-9053. This lesson is $10.00.

Educational Review Systems is accredited by the Accreditation Council of Pharmacy Education (ACPE) as a provider of continuing pharmaceutical education. This program is approved for 1 hour (0.1 CEUs) of continuing pharmacy education credit. Proof of

participation will be posted to your NABP CPE profile within 4 to 6 weeks to participants who have successfully completed the post-test. Participants must participate in the entire presentation and complete the course evaluation to receive continuing pharmacy education credit.

Learning objectives � Recognize the types of prescribers who may prescribe medications

in the state of Texas and any restrictions to their prescribing authority.

� Discuss requirements for filling prescriptions in Texas, including requirements for filling prescriptions written by Mexican and Canadian prescribers.

� Explain generic substitution requirements in Texas. � Describe the valid time frame for dispensing refills of medications

in Texas, including refill and time frame restrictions on controlled substances.

� Describe the requirements for the sale of pseudoephedrine, including quantity limits and record keeping.

� Explain the pharmacy record keeping requirements under Texas law.

� Discuss the responsibilities of pharmacy technicians. � Identify the licensing and continuing education requirements for

pharmacy technicians.

IntroductionState laws and regulations governing pharmacy practice are extremely important in the day-to-day work of a pharmacy associate. From the licenses needed to work in the pharmacy to the rules about your records and more, laws and regulations govern every aspect of daily pharmacy operation. As a pharmacy employee, is imperative to maintain a working knowledge of state pharmacy laws and to continue to learn about new laws that have been passed as well.

Each state has variations in pharmacy laws that differ from other states. While state laws in Texas are similar to others, there are

significant differences that also must be reviewed. This course is designed to be an overview of the pertinent state pharmacy laws in Texas for pharmacists and pharmacy technicians.

Note: Information included in this course was current at the time of writing. Remember that laws may change, and be sure to consult the Texas Board of Pharmacy for a thorough explanation of each law. This is an overview of the pertinent Texas state laws, and may not be all-inclusive.

Texas State Board of Pharmacy1

The Texas State Board of Pharmacy is the governing body for pharmacy affairs in the state of Texas, and is also responsible for issuing licenses for pharmacists, interns, technicians, pharmacies, drug wholesalers, and drug manufacturers.

The board consists of nine members: six pharmacists and three members of the public. The pharmacists who are members of the Board of Pharmacy must have at least five years of experience before they are eligible for appointment, and be actively practicing pharmacy as a licensed pharmacist in good standing in Texas at the time of appointment. Pharmacist members must be a resident of Texas at the time of appointment. The board must have members who work at Class A (retail) and Class C (hospital) pharmacies. Pharmacists can serve six-year terms on the Board of Pharmacy.

The public members of the Board of Pharmacy are not eligible for appointment if the nominee or their spouse meets any of the following criteria:

● Certified or licensed as a health care provider.

● Works for a business or organization that receives money from the Board of Pharmacy.

● Controls more than 10 percent of a business that receives money from the Board of Pharmacy.

● Receives a substantial amount of money or services from the Board of Pharmacy.

● Works as a paid employee of the Texas Trade Commission in health care.

● Is required to register as a lobbyist.

The appointed members of the Board of Pharmacy must complete a training program before becoming eligible to act as a member of the board. The Board of Pharmacy must elect a president and officers annually. The president must be present at all board meetings; an officer may act in place of the president if the president is not present. The Board of Pharmacy must hold at least three meetings per year to conduct board business, and meet twice per year to evaluate applicants to the board.

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Who can prescribe medications in Texas?2

In the state of Texas, many different types of practitioners can prescribe medications to patients. It is very important to be aware of

the various types of prescribers and their authority limits to ensure prescriptions are filled within the limits of the law.

Type of prescriber Prescription authorityMedical doctor Unlimited prescribing authority.Dentist Independent prescribing authority limited to scope of practice – prescribing authority is limited to treatment of

mouth, teeth and gums.Podiatrist Independent prescribing authority limited to scope of practice – prescribing authority is limited to treatment of

feet.Veterinarian Independent prescribing authority limited to scope of practice – prescribing authority is limited to treatment of

animals.Physician assistant Can prescribe non-controlled medications. Can prescribe and administer up to a 30-day supply of controlled

substances in Schedules III-V.Registered nurse practitioner Can prescribe non-controlled medications. Can prescribe and administer up to a 30-day supply of controlled

substances in Schedules III-V.EMT/paramedic Does not have any prescribing authority.Chiropractor Does not have any prescribing authority. Naturopathic doctor Does not have any prescribing authority.

Optometrist Can prescribe non-controlled medications. Can prescribe and administer up to controlled substances in Schedules III-V, can administer but not prescribe Schedule II controlled substances.

Pharmacist Can initiate and alter non-controlled medication therapy under an agreement with a licensed physician with a set protocol after notifying the Board of Pharmacy.3

Prescription requirements in Texas4

Prescriptions filled in Texas must meet the following requirements: ● Prescriptions must be written by a prescriber with prescribing

authority in Texas as noted in the chart in the previous section. ● Handwritten prescriptions must include the prescriber’s actual

signature. ● Prescription orders sent to the pharmacy in electronic format must

include the prescriber’s electronic signature, and must be printed or reduced to writing before filling the prescription.

● Written prescriptions that are printed from an electronic database and given to the patient may use the prescriber’s actual or electronic signature. Printed prescriptions given to a patient that only use the prescriber’s electronic signature must be printed on tamper-resistant paper.

● Oral prescription orders may be called in to the pharmacy if the pharmacist reduces the prescription to writing immediately.

● Prescription orders may also be sent by the prescriber’s office via fax or email.

● The patient may send prescription orders via fax or email if the prescription hard copy is presented to the pharmacy upon pickup of the medication.

● All written prescriptions filled for patients using Texas Medicaid or federal Medicare services for payment must be printed on tamper-resistant paper to prevent copying and fraud. This requirement is not to be applied to prescriptions sent to the pharmacy by fax, email, or verbally.

● All Schedule II controlled substances prescriptions must be printed on an official form required by the Texas Controlled Substance Act.

Prescriptions for non-controlled substances written by prescribers licensed in Canada or Mexico may be filled in Texas. Prescriptions written for federally controlled substances by Canadian or Mexican prescribers may not be filled in Texas.

Generic substitution and DAW5

Prescriptions filled in Texas should be dispensed as they are written if the prescriber writes on the prescription any variation of the terms DAW (dispense as written), brand medically necessary, or do not substitute. The generic product substituted for the brand name written on the prescription must be FDA-approved and listed as bioequivalent to the brand name product in the Orange Book.

If a the prescriber indicates that substitution is permitted on the prescription, the patient should be told that “A less expensive generically equivalent drug is available for the brand prescribed,” and the patient should be given the option to choose between the brand and generic product.

Refills and valid time frame for filling prescriptions6

Prescriptions filled in Texas for non-controlled substances are valid for one year from the written date, and may only be refilled within this time frame. Prescriptions for schedule III-V controlled substances

are valid for six months from the written date, and may be refilled up to five times. Schedule II prescriptions are valid for 21 days from the written date and may not be refilled.

Dispensing controlled substances without prescriptionIn the state of Texas, Schedule V controlled substances, such as codeine cough syrup, may not be sold to a patient without a prescription.7

Pseudoephedrine is regulated in Texas because it is a common product used in the manufacture of methamphetamine. Regulations have been put in place to deter people from purchasing large amounts

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of pseudoephedrine for methamphetamine production, in order to decrease the production of this drug in Texas.

These regulations include:8

● Pseudoephedrine can only be sold by pharmacies licensed by the Texas Board of Pharmacy or alternative sites that have been certified in the sale of pseudoephedrine.

● All sales must be recorded in a real-time electronic log that verifies the quantity of pseudoephedrine purchased recently. If the electronic log says the person has exceeded his or her limit, the pseudoephedrine product may not be sold.

○ A written log must be kept in case of electronic log failure. ○ Sales records must be kept for at least two years. ○ Sales records must include the name and address of the person

purchasing pseudoephedrine, the date and time the sale was made, the name and quantity of the product purchased, and

include the signature of the purchaser as well as the type of identification given and the identification number.

● A state-issued photo identification card, driver’s license, or passport must be presented at time of purchase.

● All products containing pseudoephedrine must be kept behind the counter or in a locked cabinet no more than 30 feet from a cashier and in the cashier’s line of sight.

● There are strict limits on how much pseudoephedrine can be purchased at once. No more than 9 grams of pseudoephedrine may be purchased by a single person within a 30-day period, and no more than 3.6 grams may be purchased per person per day. This is to decrease the availability of pseudoephedrine and limit its use in the production of methamphetamine.

○ These rules do not apply to prescriptions written for pseudoephedrine – only for over-the-counter sales without a prescription.

Transferring prescriptions9

Prescriptions may be transferred between pharmacies by pharmacists or graduate interns. When a prescription is transferred out, it must be invalidated by the transferring pharmacy by writing VOID on the original prescription hard copy, or ensuring it is invalidated in the pharmacy’s dispensing computer system. The name, address, and phone number or other means of identification of the receiving pharmacy shall be copied onto the back of the hard copy prescription or saved in the pharmacy’s computer system.

The prescription order for a non-controlled substance taken down by the receiving pharmacy must include the word transfer, the original written date of the prescription, the first and last dates the prescription was dispensed, the original number of refills, the number of refills remaining, the name, address, and phone number of the original pharmacy or other identifying information, the prescription number at

the original pharmacy, the name of the pharmacist or graduate intern from whom the prescription was transferred, and the name of the receiving pharmacist or graduate intern.

Prescriptions for Schedule III, IV, and V controlled substances may only be transferred between two licensed pharmacists, and may only be transferred one time. The same information as for a non-controlled substance is recorded for a controlled substance, and both pharmacists must record the DEA number of the other pharmacy on the transfer order.

Prescriptions may be transferred into Texas from out of state if they meet all of the above requirements for prescription transfers and are prescribed by a prescriber with prescriptive authority in Texas. See section titled “Who can prescribe in Texas?” for details on what prescribers have prescriptive authority in Texas.

Record keeping requirements4

All records must be kept in a readily accessible area for at least two years. This includes prescription hard copies, daily sales records, immunization records, prescription transfer records, logbooks for

pseudoephedrine and controlled substance sales, and any records required to be kept by federal or state laws.

Pharmacy licensure10

All pharmacies, drug wholesalers, drug storage facilities, and drug manufacturers in Texas must be licensed with the Board of Pharmacy, and these licenses must be renewed every other year.

If a company with several facilities is seeking licensure, a separate application must be completed for each location desiring licensure.

Pharmacist licensure and continuing education requirements for pharmacists11

Pharmacists can obtain their licenses from the Texas Board of Pharmacy. To be eligible for a pharmacist license, applicants must graduate from an accredited school of pharmacy recognized by the board, successfully complete a practical experience program supervised by a licensed pharmacist, pass the pharmacist licensure exam and state jurisprudence exam, pay a pharmacist application fee to the Board of Pharmacy, and be of good moral character.

All pharmacists must renew their licenses every other year, and all pharmacist licenses expire on the assigned expiration date. To be eligible for renewal, pharmacists must complete 30 hours (3 CEUs)

every two years. After January 1, 2015, one hour (0.1 CEU) must be on the topic of pharmacy law. Proof of continuing education completion should be retained for three years.

Pharmacists who wish to serve as preceptors to pharmacy interns must register for a preceptor certification with the Board of Pharmacy. To be eligible for a preceptor license, the applicant must be a licensed pharmacist with an unrestricted license, have at least one year of experience actively working as a licensed pharmacist, and complete at least three hours of preceptor training. Pharmacists who act as preceptors may only supervise one intern at a time.12

Pharmacy intern responsibilities13

Pharmacy interns can work in a pharmacy under a licensed pharmacist or pharmacist preceptor once they become registered and licensed with the Board of Pharmacy.

The pharmacy intern may perform the following tasks under the immediate supervision of a licensed pharmacist preceptor:

● Enter prescription data into a computer system and prepare medications for a pharmacist’s final check.

● Receive refill request authorizations. ● Compound sterile and non-sterile medications after completion of

training. ● Prepackaging and loading bulk medications into an automatic

dispensing machine. ● Administer immunizations after completion of training.

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If a pharmacist preceptor is not present and the intern is only working under the supervision of a licensed pharmacist, the pharmacist may only perform the approved duties of a pharmacy technician.

Pharmacy technician responsibilities14 Pharmacy technicians and pharmacy technician trainees must be registered and licensed with the Board of Pharmacy to work in a pharmacy, and the license must be renewed every other year. People interested in working as a pharmacy technician must be 18 or older, possess a high school diploma or GED certificate, and be of decent moral character.

To apply for a pharmacy technician license, the person must take the Pharmacy Technician Certification Board exam (PTCB exam) and pass with a satisfactory score. Pharmacy technicians in training must apply for a pharmacy technician trainee license to complete their training in a pharmacy; trainee licenses are valid for two years and may not be renewed.

Pharmacy technicians may perform the following tasks when working under the supervision of a licensed pharmacist:15

● Accept approval of refill authorizations from a prescriber or representative.

● Enter information into a patient’s profile. ● Enter prescription information into a patient’s file to create a

prescription label for verification by a pharmacist. ● Reconstitute powdered medications if ingredients added are

verified by a pharmacist before reconstitution, and the final product is verified after reconstitution.

● Count out or pour medications into bottles for verification by a pharmacist.

● Compound sterile and non-sterile medications after completion of training.

● Prepackaging and loading bulk medications into an automatic dispensing machine.

● Prepare medication for dispensing in the inpatient hospital setting, for verification by a pharmacist.

Note: Pharmacy technicians cannot record new prescriptions called in by a prescriber. This includes any changes made to a refill prescription, because a refilled prescription that has been changed is considered a new prescription.

Technicians who wish to compound prescription medications must successfully pass a training program. The training program must address the following guidelines:

● The tasks the pharmacy technician will be required to perform. ● Preparation of the area to be used for compounding of prescription

medications. ● Preparation of the products to be used in the compounding of a

prescription product. ● Aseptic technique to be used for the preparation of prescription

products in a sterile environment. ● How to properly package and label prescription products. ● Proper cleanup of the medication compounding area, including

procedures for hazardous waste cleanup.

Note: Only pharmacy technicians who have successfully completed a medication compounding training program may compound prescription medications, which MUST receive final verification by a pharmacist!

Pharmacy technician continuing education requirements14

In Texas, pharmacy technicians need to obtain a license from the Board of Pharmacy to work in a pharmacy. To maintain their license, technicians must complete 20 hours of continuing education every

two years. After January 1, 2015, one hour must be on the topic of pharmacy law. Proof of continuing education completion should be retained for three years.

Pharmacists administering immunizations16

In the state of Texas, pharmacists who are certified to give immunizations may immunize patients under the supervision of a physician. Immunizations may be given based on the written protocol with the supervising physician.

Certified pharmacists may immunize adults and children aged 14-18 years according to the protocol established with the supervising physician. All vaccines except influenza for children aged 7-14 years require referral from a prescriber with a valid relationship with the patient.

Pharmacists must be trained and certified in immunization delivery before they are eligible to apply for a certificate to immunize patients. The training program must include the following information:

● Immunology and the immune response involved in immunization of patients.

● Names of available vaccines, dose, side effects, immunization schedule, and how immunity occurs with each available vaccine.

● How to respond to emergencies that occur due to the administration of a vaccine, including how to administer epinephrine or diphenhydramine to slow the effects of an allergic reaction to a vaccine.

● How to administer intramuscular and subcutaneous injections. ● Proper record keeping requirements and reporting requirements for

adverse effects and prescriber notification.

Note: The training program developed by the American Pharmacists Association (APhA) meets the requirements for immunization training programs in Texas.

Pharmacists who have passed the immunization training program are eligible for an immunization certificate from the Board of Pharmacy as long as they have a current unrestricted pharmacist license in Texas and have a current certification in basic cardiopulmonary resuscitation (CPR). Pharmacists must apply for their immunization certificate with the Board of Pharmacy and receive board approval before administering immunizations to patients in Texas.

Interns may administer vaccinations after completion of a certification course and certification by the Board of Pharmacy, but only under the supervision of a licensed, immunization-certified preceptor pharmacist.

Once interns or pharmacists are certified to administer immunizations, the certification must be maintained by holding a current certificate in basic cardiopulmonary resuscitation and completing of three hours of continuing education every two years related to the administration of immunizations.

Immunizations given must have accurate records maintained at the pharmacy. Each immunization given must have documentation that includes:

● A copy of the written protocol used to determine eligibility to receive immunization.

● The patient’s name and address. ○ Age must be included if the patient is under 14 years old.

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● The date the immunization was given and the injection site. ● The name of vaccine given as well as the dose, route, lot number,

and manufacturer. ● The name of the patient’s primary care physician. ● The name, address, and title of the pharmacist or graduate intern

who gave the immunization.

Documentation of vaccinations given to patients must be sent to the patient’s primary care physician within 14 days of immunization. Documentation also must be sent to the supervising physician within 24 hours of administration of a vaccine. Records must be kept in a readily accessible place for at least two years for possible inspection by the Board of Pharmacy.

ConclusionTexas state pharmacy laws dictate the daily operations of pharmacies and pharmacy employees. It is important to stay up-to-date on new pharmacy laws that govern daily practice to serve patients within the limits of the law and obtain continuing education credits to maintain

licensure. Information on new and current pharmacy laws in Texas can be found on the Texas Board of Pharmacy’s website at http://www.tsbp.state.tx.us/rules/.

References1. Texas Occupations Code Chapter 552: Texas State Board of Pharmacy. Accessed at http://www.

statutes.legis.state.tx.us/Docs/OC/pdf/OC.552.pdf on July 15, 2013.2. Drug Enforcement Agency. Mid-Level Practitioners Authorization by State. Accessed at http://www.

deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf on July 15, 2013.3. Texas State Board of Pharmacy. Notification of Drug Therapy Management By a Pharmacist Under

Written Protocol of a Physician. March 2013. Accessed at http://www.tsbp.state.tx.us/files_pdf/LIC-1209.pdf on July 16, 2013.

4. Texas Administrative Code Title 22 Part 15 Chapter 291 Subchapter B Rule §291.34: Records. Accessed at http://info.sos.state.tx.us/pls/pub/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=22&pt=15&ch=291&rl=34 on July 16, 2013.

5. Texas Occupations Code Chapter 562: Practice by License Holder, Subchapter A: Prescription and Substitution Requirements. Accessed at http://www.statutes.legis.state.tx.us/Docs/OC/htm/OC.562.htm on July 16, 2013.

6. Texas Administrative Code Title 37 Part 1 Chapter 13 Subchapter D Rule §13.72: Prescriptions. Accessed at http://info.sos.state.tx.us/pls/pub/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=37&pt=1&ch=13&rl=72 on July 2013.

7. Texas Health and Safety Code Title 6 Subtitle C Chapter 481: Texas Controlled Substance Act. Accessed at http://www.statutes.legis.state.tx.us/Docs/HS/htm/HS.481.htm on July 16, 2013.

8. Texas Health and Safety Code Title 6 Subtitle C Chapter 486: Over-The-Counter Sales of Ephedrine, Pseudoephedrine, and Norpseudoephedrine. Accessed at http://www.statutes.legis.state.tx.us/Docs/HS/pdf/HS.486.pdf on July 16, 2013.

9. Code of Federal Regulations, Section 1306.25 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes. Accessed at http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_25.htm on July 17, 2013.

10. Texas Administrative Code Title 22 Part 15 Chapter 291 Subchapter A: All Classes of Pharmacies. Accessed at http://info.sos.state.tx.us/pls/pub/readtac$ext.ViewTAC?tac_view=5&ti=22&pt=15&ch=291&sch=A&rl=Y on July 17, 2013.

11. Texas Administrative Code Title 22 Part 15 Chapter 295: Pharmacists. Accessed at http://info.sos.state.tx.us/pls/pub/readtac$ext.ViewTAC?tac_view=4&ti=22&pt=15&ch=295&rl=Y on July 17, 2013.

12. Texas Administrative Code Title 22 Part 15 Chapter 283 Rule § 283.6: Preceptor Requirements and Ratio of Preceptors to Pharmacist-Interns. Accessed at http://info.sos.state.tx.us/pls/pub/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=22&pt=15&ch=283&rl=6 on July 17, 2013.

13. Texas Administrative Code Title 22 Part 15 Chapter 283 Rule § 283.5: Pharmacist-Intern Duties. Accessed at http://info.sos.state.tx.us/pls/pub/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=22&pt=15&ch=283&rl=5 on July 17, 2013.

14. Texas Administrative Code Title 22 Part 15 Chapter 297: Pharmacy Technicians and Pharmacy Technician Trainees. Accessed at http://info.sos.state.tx.us/pls/pub/readtac$ext.ViewTAC?tac_view=4&ti=22&pt=15&ch=297&rl=Y on July 17, 2013.

15. Texas State Board of Pharmacy. Duties of Pharmacy Technicians and Pharmacy Technician Trainees In Class A (Community) Pharmacy Under the Supervision of a Pharmacist. Accessed at http://www.tsbp.state.tx.us/files_pdf/tech_duty_chart_2012.pdf on July 17, 2013.

16. Texas Administrative Code Title 22 Part 15 Chapter 295 Rule § 295.15: Administration of Immunizations or Vaccinations by a Pharmacist under Written Protocol of a Physician. Accessed at http://info.sos.state.tx.us/pls/pub/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_

ploc=&pg=1&p_tac=&ti=22&pt=15&ch=295&rl=15 on July 17, 2013.

OveRvIeW Of TexAS PHARMACy LAWFinal Examination Questions

Choose the best answer for questions 1 through 5 and mark your answers online at Pharmacy.EliteCME.com

1. How many members of the Texas Board of Pharmacy are pharmacists?a. Nine.b. Six. c. Two.d. One.

2. Which of the following practitioners does not have any prescribing authority in Texas? a. Chiropractor.b. Medical doctor.c. Podiatrist.d. Optometrist.

3. What is the maximum amount of pseudoephedrine that may be purchased by one person without a prescription in a single day? a. 3.6 grams.b. 9 grams.c. 7.5 grams.d. 3 grams.

4. How long must prescription hard copies be kept in a readily accessible area?a. Two years. b. Three years.c. Seven years.d. Nine years.

5. How many hours of continuing education must a pharmacy technician complete every two years?a. 15 hours.b. 2 hours.c. 20 hours.d. 30 hours.

RPTX01TLE15

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