PART 1. TEXAS BOARD OF ARCHITECTURAL EXAMINERS
The Texas Board of Architectural Examiners adopts an amendment to §7.10, pertaining to fees, with changes to the proposed text as published in the July 4, 2008, issue of the Texas Register (33 TexReg 5217). All of the changes are in the graphic attached to the rule. Some of the coding that is used to denote new text and deleted text was inadvertently omitted. Specifically, in footnotes marked ** and ***, the new fees for 2008 and 2009 were provided but not marked as new text; the footnote marked **** included text which noted the fee for ARE Version 3.1 and provided the new fee for ARE Version 4.0. The heading for the first column of fees was incorrectly shown as "Architects Interior" and was corrected to "Architects" and the next-to-last item in the fee schedule, a fee for review of the landscape architecture examination, was not marked as being deleted. The deletion of this item was mentioned in the preamble but the coding to delete it was accidentally omitted.
The amended rule reduces fees for emeritus registration renewal. Since the penalty for late renewal is a percentage of the renewal fee, the amendment makes a corresponding reduction to the amount of the penalty. The amendment also modifies the late renewal period to which the penalty would apply in order to conform to legislative changes which extend the period during which an expired registration may be renewed. The amendment also includes the fee that will be charged by the examination provider for a new version of the architectural registration examination which became available in July 2008. The amendment clarifies that a fee paid by a check which is refused by the bank upon which the check is drawn due to insufficient funds, errors in routing, or errors in the bank account number will be considered unpaid and late penalties or other penalties will accrue upon the unpaid fee. The amendment also eliminates an obsolete fee for review of the landscape architectural registration examination. The purpose of the amendment is to make the fees for emeritus status less costly for retired registrants and more equitable for out-of-state emeritus registrants. The amendment also serves to reflect the current fees charged by the examination providers and provide notice that the fee paid by a check which is not honored by the bank is not considered paid. As adopted, emeritus fees charged by the board will be lower and the fee schedule will provide accurate notice of the fees charged under current law and the current examination fees charged by the examination providers.
As a result of this amendment, there will be a reduction in the cost to retirees to maintain emeritus registration status and clarification of notice to candidates regarding the fee charged by examination providers for the current registration examinations. The rule will also accurately reflect recent legislative changes that provide for the cancellation of an expired certificate of registration two years after it expires in lieu of one year after expiration. The rule will have no adverse impact on small or micro business. Since the rule will not adversely impact small business, the board is not required to prepare an economic impact statement or flexibility analysis and did not prepare one.
The agency received no comments concerning the proposal to amend this rule.
The amendment is adopted pursuant to §§1051.202, 1051.353, 1051.651, 1051.357, 1052.054, 1052.155, 1053.052, and 1053.156 of the Texas Occupations Code Annotated and §14(a) of Article 8930, Texas Civil Statutes Annotated, which provide the Texas Board of Architectural Examiners with authority to promulgate rules, set fees to cover the cost of administering its laws, impose penalties for late renewal of registration, and charge a fee for the registration and renewal as an emeritus registrant.
§7.10.General Fees.
(a) FAILURE TO TIMELY PAY A REGISTRATION RENEWAL WILL RESULT IN THE AUTOMATIC CANCELLATION OF REGISTRATION BY OPERATION OF LAW.
(b) Effective September 1, 2008, the following fees shall apply to services provided by the Board in addition to any fee established elsewhere by the rules and regulations of the Board or by Texas law:
(c) The Board cannot accept cash as payment for any fee.
(d) An official postmark from the U.S. Postal Service or other delivery service receipt may be presented to the Board to demonstrate the timely payment of any fee.
(e) If a check is submitted to the Board to pay a fee and the bank upon which the check is drawn refuses to pay the check due to insufficient funds, errors in routing, or bank account number, the fee shall be considered unpaid and any applicable late fees or other penalties accrue. The Board shall impose a processing fee for any check that is returned unpaid by the bank upon which the check is drawn.
(f) A Registrant who is in Good Standing or was in Good Standing at the time the Registrant entered into military service shall be exempt from the payment of any fee during any period of active duty service in the U.S. military. The exemption under this subsection shall continue through the remainder of the fiscal year during which the Registrant's active duty status expires.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on August 12, 2008.
TRD-200804296
Cathy L. Hendricks, ASID/IIDA
Executive Director
Texas Board of Architectural Examiners
Effective date: September 1, 2008
Proposal publication date: July 4, 2008
For further information, please call: (512) 305-8544
CHAPTER 281. ADMINISTRATIVE PRACTICE AND PROCEDURES
SUBCHAPTER C. DISCIPLINARY GUIDELINES
The Texas State Board of Pharmacy adopts amendments to §281.62, concerning Aggravating and Mitigating Factors, §281.63, concerning Considerations for Criminal Offenses, §281.64, concerning Sanctions for Criminal Offenses, and §281.65, concerning Schedule of Administrative Penalties. The amendments are adopted without changes to the proposed text as published in the June 20, 2008, issue of the Texas Register (33 TexReg 4785).
The amendments clarify disciplinary guidelines to reflect that the Board has given careful consideration to the guidelines and intends the guidelines to reflect the regulatory polices and goals of the Board to protect the public health and safety.
No comments were received regarding adoption of the amendments.
The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on August 18, 2008.
TRD-200804414
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: September 7, 2008
Proposal publication date: June 20, 2008
For further information, please call: (512) 305-8028
SUBCHAPTER A. ALL CLASSES OF PHARMACIES
The Texas State Board of Pharmacy adopts new §291.15, concerning Storage of Drugs. The new rule is adopted without changes to the proposed text as published in the June 20, 2008, issue of the Texas Register (33 TexReg 4789).
The new rule provides the storage requirements for drugs in all classes of pharmacies.
No comments were received regarding adoption of the new rule.
The new rule is adopted under §551.002, and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by this rule: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on August 18, 2008.
TRD-200804415
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: September 7, 2008
Proposal publication date: June 20, 2008
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy adopts amendments to §291.31, concerning Definitions, §291.32, concerning Personnel, §291.33, concerning Operational Standards, and §291.34, concerning Records. The amendments to §§291.31, 291.33 and 291.34 are adopted with changes to the proposed text as published in the March 21, 2008, issue of the Texas Register (33 TexReg 2462). The amendments to §291.32 are adopted without changes and will not be republished.
The changes to §291.31(3) updates the name from "Texas State Board of Nurse Examiners" to "Texas Board of Nursing". The changes amend §291.33 and §291.34 to allow pharmacies additional time to comply with the rules regarding documentation of patient counseling; and amend §291.33 to include other types of locking systems with regard to security of the pharmacy and to allow pharmacists to take short breaks from the pharmacy while on-site but not define a specific amount of time that the pharmacist may take a break.
The amendments incorporate recommendations made by the Task Force on Pharmacy Security in Community (Class A) Pharmacies; clarify the definition of the prescription department; clarify the responsibilities of the owner to include establishing polices and procedures for the security of the prescription department; outline the security requirements for Class A pharmacies; clarify the temporary absence requirements for pharmacists; require the pharmacy to document the identity of each pharmacist involved in a specific portion of the dispensing process if the pharmacy's data processing system is capable of recording such information; require the pharmacy to document the identity of the pharmacist responsible for providing verbal counseling on a new prescription; and implement S.B. 1658, passed by the 80th Texas Legislature, allowing pharmacists to dispense up to a 30-day supply of prescription drugs in the event of a manmade or natural disaster.
Comments were received as follows:
H.E.B. and the Texas Federation of Drug Stores (TFDS)commented in support of adoption of the amendments to §291.32 regarding the documentation of the identify of each pharmacist involved in a specific portion of the dispensing process if the pharmacy's data processing system is capable of recording such information. The Board agrees with these comments.
The Texas Pharmacy Association (TPA), National Association of Chain Drug Stores (NACDS), and American Pharmacies commented on the amendments to §291.33 regarding the security requirements. TPA suggested that pharmacies be allowed to not have a pharmacist on-site for up to a 2 hour period during a 24 hour day and allow pharmacy technicians to work in the pharmacist's absence. American Pharmacies opposed the amendments regarding the temporary absence provisions for a pharmacist to be off-site and on-site and recommended that there be no specific timeframes in the rules and the pharmacy technicians be allowed to work in the pharmacy in the pharmacist's absence. The Board disagrees with these comments because the Texas Pharmacy Act, Section 562.101(a) requires a pharmacy to be under the "continuous on-site supervision of a pharmacist." Therefore, a pharmacy may not be open for pharmacy services if a pharmacist is not on-site. NACDS commented in support of §291.33 recognizing that in order to expand the rules to allow pharmacy technicians and pharmacy technician trainees to work in the pharmacy when a pharmacist is off-site would require a change in statute. The Board agrees with this comment.
American Pharmacies commented that the rules regarding the security requirements for pharmacies that change location should be clarified to state that pharmacies that change ownership but do not change location are exempt from the provisions. The Board agrees with the comments and amended the rules as such.
NACDS commented that §291.33 should be amended to include other types of systems or technologies to secure the pharmacy from unauthorized entrance when the pharmacy is closed. NACDS also commented that the rule requires the pharmacist-in-charge to designate individuals who may access the pharmacy. NACDS recommends that in for emergency situations individuals should be allowed to be designated by title. The Board agrees with these comments and amended the rules as such.
H.E.B., NACDS, TPA, and TFDS commented on the requirements for documenting patient counseling. TPA commented that the rules should be withdrawn. The Board disagrees with this comment and believes that documentation of the pharmacist responsible for counseling is an important tool to ensure that patients are being counseled by the pharmacist. H.E.B., NACDS, and TFDS commented that pharmacies may need additional time to comply with the requirements. The Board agrees with these comments and amended the rules to allow pharmacies until June 1, 2010, to comply with the requirements. NACDS also requested that pharmacies be able to use other methods for documenting counseling. The Board agrees with this comment and amended the rules to allow other forms of documentation.
TFDS commented in support of §291.34 regarding the provisions for emergency dispensing of a 30 day supply of drugs in the event of a disaster. The Board agrees with this comment.
The amendments are adopted under §551.002 and §554.051, of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.31.Definitions.
The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.
(1) Accurately as prescribed--Dispensing, delivering, and/or distributing a prescription drug order:
(A) to the correct patient (or agent of the patient) for whom the drug or device was prescribed;
(B) with the correct drug in the correct strength, quantity, and dosage form ordered by the practitioner; and
(C) with correct labeling (including directions for use) as ordered by the practitioner. Provided, however, that nothing herein shall prohibit pharmacist substitution if substitution is conducted in strict accordance with applicable laws and rules, including Chapters 562 and 563 of the Texas Pharmacy Act.
(2) Act--The Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Occupations Code, as amended.
(3) Advanced practice nurse--A registered nurse approved by the Texas Board of Nursing to practice as an advanced practice nurse on the basis of completion of an advanced education program. The term includes a nurse practitioner, a nurse midwife, a nurse anesthetist, and a clinical nurse specialist.
(4) Automated compounding or counting device--An automated device that compounds, measures, counts, and/or packages a specified quantity of dosage units of a designated drug product.
(5) Automated pharmacy dispensing systems--a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, dispensing, and distribution of medications, and which collects, controls, and maintains all transaction information. "Automated pharmacy dispensing systems" does not mean "Automated compounding or counting devices" or "Automated medication supply devices."
(6) Board--The Texas State Board of Pharmacy.
(7) Carrying out or signing a prescription drug order--The completion of a prescription drug order presigned by the delegating physician, or the signing of a prescription by an advanced practice nurse or physician assistant after the person has been designated with the Texas Medical Board by the delegating physician as a person delegated to sign a prescription. The following information shall be provided on each prescription:
(A) patient's name and address;
(B) name, strength, and quantity of the drug to be dispensed;
(C) directions for use;
(D) the intended use of the drug, if appropriate;
(E) the name, address, and telephone number of the physician;
(F) the name, address, telephone number, identification number, and if the prescription is for a controlled substance, the DEA number of the advanced practice nurse or physician assistant completing the prescription drug order;
(G) the date; and
(H) the number of refills permitted.
(8) Confidential record--Any health-related record that contains information that identifies an individual and that is maintained by a pharmacy or pharmacist, such as a patient medication record, prescription drug order, or medication order.
(9) Controlled substance--A drug, immediate precursor, or other substance listed in Schedules I - V or Penalty Groups 1-4 of the Texas Controlled Substances Act, as amended, or a drug, immediate precursor, or other substance included in Schedules I, II, III, IV, or V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513).
(10) Dangerous drug--A drug or device that:
(A) is not included in Penalty Group 1, 2, 3, or 4, Chapter 481, Health and Safety Code, and is unsafe for self-medication; or
(B) bears or is required to bear the legend:
(i) "Caution: federal law prohibits dispensing without prescription" or "Rx only" or another legend that complies with federal law; or
(ii) "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian."
(11) Data communication device--An electronic device that receives electronic information from one source and transmits or routes it to another (e.g., bridge, router, switch or gateway).
(12) Deliver or delivery--The actual, constructive, or attempted transfer of a prescription drug or device or controlled substance from one person to another, whether or not for a consideration.
(13) Designated agent--
(A) a licensed nurse, physician assistant, pharmacist, or other individual designated by a practitioner to communicate prescription drug orders to a pharmacist;
(B) a licensed nurse, physician assistant, or pharmacist employed in a health care facility to whom the practitioner communicates a prescription drug order;
(C) an advanced practice nurse or physician assistant authorized by a practitioner to carry out or sign a prescription drug order for dangerous drugs under Chapter 157 of the Medical Practice Act (Subtitle B, Occupations Code); or
(D) a person who is a licensed vocational nurse or has an education equivalent to or greater than that required for a licensed vocational nurse designated by the practitioner to communicate prescriptions for an advanced practice nurse or physician assistant authorized by the practitioner to sign prescription drug orders under Chapter 157 of the Medical Practice Act (Subtitle B, Occupations Code).
(14) Dispense--Preparing, packaging, compounding, or labeling for delivery a prescription drug or device in the course of professional practice to an ultimate user or his agent by or pursuant to the lawful order of a practitioner.
(15) Dispensing pharmacist--The pharmacist responsible for the final check of the dispensed prescription before delivery to the patient.
(16) Distribute--The delivery of a prescription drug or device other than by administering or dispensing.
(17) Downtime--Period of time during which a data processing system is not operable.
(18) Drug regimen review--An evaluation of prescription drug orders and patient medication records for:
(A) known allergies;
(B) rational therapy-contraindications;
(C) reasonable dose and route of administration;
(D) reasonable directions for use;
(E) duplication of therapy;
(F) drug-drug interactions;
(G) drug-food interactions;
(H) drug-disease interactions;
(I) adverse drug reactions; and
(J) proper utilization, including overutilization or underutilization.
(19) Electronic prescription drug order--A prescription drug order which is transmitted by an electronic device to the receiver (pharmacy).
(20) Electronic signature--A unique security code or other identifier which specifically identifies the person entering information into a data processing system. A facility which utilizes electronic signatures must:
(A) maintain a permanent list of the unique security codes assigned to persons authorized to use the data processing system; and
(B) have an ongoing security program which is capable of identifying misuse and/or unauthorized use of electronic signatures.
(21) Full-time pharmacist--A pharmacist who works in a pharmacy from 30 to 40 hours per week or, if the pharmacy is open less than 60 hours per week, one-half of the time the pharmacy is open.
(22) Hard copy--A physical document that is readable without the use of a special device (i.e., cathode ray tube (CRT), microfiche reader, etc.).
(23) Hot water--The temperature of water from the pharmacy's sink maintained at a minimum of 105 degrees F (41 degrees C).
(24) Medical Practice Act--The Texas Medical Practice Act, Subtitle B, Occupations Code, as amended.
(25) Medication order--A written order from a practitioner or a verbal order from a practitioner or his authorized agent for administration of a drug or device.
(26) New prescription drug order--A prescription drug order that:
(A) has not been dispensed to the patient in the same strength and dosage form by this pharmacy within the last year;
(B) is transferred from another pharmacy; and/or
(C) is a discharge prescription drug order. (Note: furlough prescription drug orders are not considered new prescription drug orders.)
(27) Original prescription--The:
(A) original written prescription drug order; or
(B) original verbal or electronic prescription drug order reduced to writing either manually or electronically by the pharmacist.
(28) Part-time pharmacist--A pharmacist who works less than full-time.
(29) Patient counseling--Communication by the pharmacist of information to the patient or patient's agent in order to improve therapy by ensuring proper use of drugs and devices.
(30) Pharmaceutical care--The provision of drug therapy and other pharmaceutical services intended to assist in the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process.
(31) Pharmacist-in-charge--The pharmacist designated on a pharmacy license as the pharmacist who has the authority or responsibility for a pharmacy's compliance with laws and rules pertaining to the practice of pharmacy.
(32) Pharmacy technician--An individual who is registered with the board as a pharmacy technician and whose responsibility in a pharmacy is to provide technical services that do not require professional judgment regarding preparing and distributing drugs and who works under the direct supervision of and is responsible to a pharmacist.
(33) Pharmacy technician trainee--An individual who is registered with the board as a pharmacy technician trainee and is authorized to participate in a pharmacy's technician training program.
(34) Physician assistant--A physician assistant recognized by the Texas Medical Board as having the specialized education and training required under Subtitle B, Chapter 157, Occupations Code, and issued an identification number by the Texas Medical Board.
(35) Practitioner--
(A) a person licensed or registered to prescribe, distribute, administer, or dispense a prescription drug or device in the course of professional practice in this state, including a physician, dentist, podiatrist, or veterinarian but excluding a person licensed under this subtitle;
(B) a person licensed by another state, Canada, or the United Mexican States in a health field in which, under the law of this state, a license holder in this state may legally prescribe a dangerous drug;
(C) a person practicing in another state and licensed by another state as a physician, dentist, veterinarian, or podiatrist, who has a current federal Drug Enforcement Administration registration number and who may legally prescribe a Schedule II, III, IV, or V controlled substance, as specified under Chapter 481, Health and Safety Code, in that other state; or
(D) an advanced practice nurse or physician assistant to whom a physician has delegated the authority to carry out or sign prescription drug orders under §§157.0511, 157.052, 157.053, 157.054, 157.0541, or 157.0542, Occupations Code.
(36) Prepackaging--The act of repackaging and relabeling quantities of drug products from a manufacturer's original commercial container into a prescription container for dispensing by a pharmacist to the ultimate consumer.
(37) Prescription department--The area of a pharmacy that contains prescription drugs.
(38) Prescription drug--
(A) a substance for which federal or state law requires a prescription before the substance may be legally dispensed to the public;
(B) a drug or device that under federal law is required, before being dispensed or delivered, to be labeled with the statement:
(i) "Caution: federal law prohibits dispensing without prescription" or "Rx only" or another legend that complies with federal law; or
(ii) "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian"; or
(C) a drug or device that is required by federal or state statute or regulation to be dispensed on prescription or that is restricted to use by a practitioner only.
(39) Prescription drug order--
(A) a written order from a practitioner or a verbal order from a practitioner or his authorized agent to a pharmacist for a drug or device to be dispensed; or
(B) a written order or a verbal order pursuant to Subtitle B, Chapter 157, Occupations Code.
(40) Prospective drug use review--A review of the patient's drug therapy and prescription drug order or medication order prior to dispensing or distributing the drug.
(41) State--One of the 50 United States of America, a U.S. territory, or the District of Columbia.
(42) Texas Controlled Substances Act--The Texas Controlled Substances Act, Health and Safety Code, Chapter 481, as amended.
(43) Written protocol--A physician's order, standing medical order, standing delegation order, or other order or protocol as defined by rule of the Texas Medical Board under the Texas Medical Practice Act.
§291.33.Operational Standards.
(a) Licensing requirements.
(1) A Class A pharmacy shall register annually or biennially with the board on a pharmacy license application provided by the board, following the procedures specified in §291.1 of this title (relating to Pharmacy License Application).
(2) A Class A pharmacy which changes ownership shall notify the board within ten days of the change of ownership and apply for a new and separate license as specified in §291.3 of this title (relating to Required Notifications).
(3) A Class A pharmacy which changes location and/or name shall notify the board within ten days of the change and file for an amended license as specified in §291.3 of this title.
(4) A Class A pharmacy owned by a partnership or corporation which changes managing officers shall notify the board in writing of the names of the new managing officers within ten days of the change, following the procedures in §291.3 of this title.
(5) A Class A pharmacy shall notify the board in writing within ten days of closing, following the procedures in §291.5 of this title (relating to Closed Pharmacies).
(6) A separate license is required for each principal place of business and only one pharmacy license may be issued to a specific location.
(7) A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for the issuance and renewal of a license and the issuance of an amended license.
(8) A Class A pharmacy, licensed under the provisions of the Act, §560.051(a)(1), which also operates another type of pharmacy which would otherwise be required to be licensed under the Act, §560.051(a)(2) concerning Nuclear Pharmacy (Class B), is not required to secure a license for such other type of pharmacy; provided, however, such licensee is required to comply with the provisions of §291.51 of this title (relating to Purpose), §291.52 of this title (relating to Definitions), §291.53 of this title (relating to Personnel), §291.54 of this title (relating to Operational Standards), and §291.55 of this title (relating to Records), contained in Nuclear Pharmacy (Class B), to the extent such sections are applicable to the operation of the pharmacy.
(9) A Class A (community) pharmacy engaged in the compounding of non-sterile pharmaceuticals shall comply with the provisions of §291.131 of this title (relating to Pharmacies Compounding Non-sterile Preparations.
(10) A Class A (community) pharmacy engaged in the compounding of sterile pharmaceuticals shall comply with the provisions of §291.133 of this title (relating to Pharmacies Compounding Sterile Preparations.
(11) A Class A (Community) pharmacy engaged in the provision of remote pharmacy services, including storage and dispensing of prescription drugs, shall comply with the provisions of §291.121 of this title (relating to Remote Pharmacy Services).
(12) Class A (Community) pharmacy engaged in centralized prescription dispensing and/or prescription drug or medication order processing shall comply with the provisions of §291.123 of this title (relating to Centralized Prescription Drug or Medication Order Processing) and/or §291.125 of this title (relating to Centralized Prescription Dispensing).
(b) Environment.
(1) General requirements.
(A) The pharmacy shall be arranged in an orderly fashion and kept clean. All required equipment shall be clean and in good operating condition.
(B) A Class A pharmacy shall have a sink with hot and cold running water within the pharmacy, exclusive of restroom facilities, available to all pharmacy personnel and maintained in a sanitary condition.
(C) A Class A pharmacy which serves the general public shall contain an area which is suitable for confidential patient counseling.
(i) Such counseling area shall:
(I) be easily accessible to both patient and pharmacists and not allow patient access to prescription drugs;
(II) be designed to maintain the confidentiality and privacy of the pharmacist/patient communication.
(ii) In determining whether the area is suitable for confidential patient counseling and designed to maintain the confidentiality and privacy of the pharmacist/patient communication, the board may consider factors such as the following:
(I) the proximity of the counseling area to the check-out or cash register area;
(II) the volume of pedestrian traffic in and around the counseling area;
(III) the presence of walls or other barriers between the counseling area and other areas of the pharmacy; and
(IV) any evidence of confidential information being overheard by persons other than the patient or patient's agent or the pharmacist or agents of the pharmacist.
(D) The pharmacy shall be properly lighted and ventilated.
(E) The temperature of the pharmacy shall be maintained within a range compatible with the proper storage of drugs; the temperature of the refrigerator shall be maintained within a range compatible with the proper storage of drugs requiring refrigeration.
(F) Animals, including birds and reptiles, shall not be kept within the pharmacy and in immediately adjacent areas under the control of the pharmacy. This provision does not apply to fish in aquariums, guide dogs accompanying disabled persons, or animals for sale to the general public in a separate area that is inspected by local health jurisdictions.
(2) Security.
(A) Each pharmacist while on duty shall be responsible for the security of the prescription department, including provisions for effective control against theft or diversion of prescription drugs, and records for such drugs.
(B) The prescription department shall be locked by key, combination or other mechanical or electronic means to prohibit unauthorized access when a pharmacist is not on-site except as provided in subparagraphs (C) and (D) of this paragraph and paragraph (3) of this subsection. The following is applicable:
(i) If the prescription department is closed at any time when the rest of the facility is open, the prescription department must be physically or electronically secured. The security may be accomplished by means such as floor to ceiling walls; walls, partitions, or barriers at least 9 feet 6 inches high; electronically monitored motion detectors; pull down sliders; or other systems or technologies that will secure the pharmacy from unauthorized entrance when the pharmacy is closed. Pharmacies licensed prior to June 1, 2009, shall be exempt from this provision unless the pharmacy changes location. Change of location shall include the relocation of the pharmacy within the licensed address. A pharmacy licensed prior to June 1, 2009 that files a change of ownership but does not change location shall be exempt from the provisions.
(ii) Effective, June 1, 2009, the pharmacy's key, combination, or other mechanical or electronic means of locking the pharmacy may not be duplicated without the authorization of the pharmacist-in-charge or owner.
(iii) Effective, June 1, 2009, at a minimum, the pharmacy must have a basic alarm system with off-site monitoring and perimeter and motion sensors. The pharmacy may have additional security by video surveillance camera systems.
(C) Prior to authorizing individuals to enter the prescription department, the pharmacist-in-charge or owner may designate persons who may enter the prescription department to perform functions, other than dispensing functions or prescription processing, documented by the pharmacist-in-charge including access to the prescription department by other pharmacists, pharmacy personnel and other individuals. The pharmacy must maintain written documentation of authorized individuals other than individuals employed by the pharmacy who accessed the prescription department when a pharmacist is not on-site.
(D) Only persons designated either by name or by title including such titles as "relief" or "floater" pharmacist, in writing by the pharmacist-in-charge may unlock the prescription department except in emergency situations. An additional key to or instructions on accessing the prescription department may be maintained in a secure location outside the prescription department for use during an emergency or as designated by the pharmacist-in-charge for entry by another pharmacist.
(E) Written policies and procedures for the pharmacy's security shall be developed and implemented by the pharmacist-in-charge and/or the owner of the pharmacy. Such polices and procedures may include quarterly audits of controlled substances commonly abused or diverted; perpetual inventories for the comparison of the receipt, dispensing, and distribution of controlled substances; monthly reports from the pharmacy's wholesaler(s) of controlled substances purchased by the pharmacy; opening and closing procedures; product storage and placement; and central management oversight.
(3) Temporary absence of pharmacist.
(A) On-site supervision by pharmacist.
(i) If a pharmacy is staffed by only one pharmacist, the pharmacist may leave the prescription department for short periods of time without closing the prescription department and removing pharmacy technicians, pharmacy technician trainees, and other pharmacy personnel from the prescription department provided the following conditions are met:
(I) at least one pharmacy technician remains in the prescription department;
(II) the pharmacist remains on-site at the licensed location of the pharmacy and is immediately available;
(III) the pharmacist reasonably believes that the security of the prescription department will be maintained in his or her absence. If in the professional judgment of the pharmacist, the pharmacist determines that the prescription department should close during his or her absence, then the pharmacist shall close the prescription department and remove the pharmacy technicians, pharmacy technician trainees, and other pharmacy personnel from the prescription department during his or her absence; and
(IV) a notice is posted which includes the following information:
(-a-) the pharmacist is on a break and the time the pharmacist will return; and
(-b-) pharmacy technicians may begin the processing of prescription drug orders or refills brought in during the pharmacist's absence, but the prescription or refill may not be delivered to the patient or the patient's agent until the pharmacist verifies the accuracy of the prescription.
(ii) During the time a pharmacist is absent from the prescription department, only pharmacy technicians who have completed the pharmacy's training program may perform the following duties, provided a pharmacist verifies the accuracy of all acts, tasks, and functions performed by the pharmacy technicians prior to delivery of the prescription to the patient or the patient's agent:
(I) initiating and receiving refill authorization requests;
(II) entering prescription data into a data processing system;
(III) taking a stock bottle from the shelf for a prescription;
(IV) preparing and packaging prescription drug orders (i.e., counting tablets/capsules, measuring liquids and placing them in the prescription container);
(V) affixing prescription labels and auxiliary labels to the prescription container; and
(VI) prepackaging and labeling prepackaged drugs.
(iii) Upon return to the prescription department, the pharmacist shall:
(I) conduct a drug regimen review as specified in subsection (c)(2) of this section; and
(II) verify the accuracy of all acts, tasks, and functions performed by the pharmacy technicians prior to delivery of the prescription to the patient or the patient's agent.
(iv) An agent of the pharmacist may deliver a previously verified prescription to the patient or his or her agent provided a record of the delivery is maintained containing the following information:
(I) date of the delivery;
(II) unique identification number of the prescription drug order;
(III) patient's name;
(IV) patient's phone number or the phone number of the person picking up the prescription; and
(V) signature of the person picking up the prescription.
(v) Any prescription delivered to a patient when a pharmacist is not in the prescription department must meet the requirements for a prescription delivered to a patient as described in subsection (c)(1)(F) of this section.
(vi) During the times a pharmacist is absent from the prescription department a pharmacist intern shall be considered a registered pharmacy technician and may perform only the duties of a registered pharmacy technician.
(vii) In pharmacies with two or more pharmacists on duty, the pharmacists shall stagger their breaks and meal periods so that the prescription department is not left without a pharmacist on duty.
(B) Pharmacist is off-site.
(i) The prescription department must be secured with procedures for entry during the time that a pharmacy is not under the continuous on-site supervision of a pharmacist and the pharmacy is not open for pharmacy services.
(ii) Pharmacy technicians and pharmacy technician trainees may not perform any duties of a pharmacy technician or pharmacy technician trainee during the time that the a pharmacist is off-site.
(iii) An agent of the pharmacist may deliver a previously verified prescription to a patient or patient's agent during short periods of time when a pharmacist is off-site, provided the following conditions are met:
(I) short periods of time may not exceed two consecutive hours in a 24 hour period;
(II) a notice is posted which includes the following information:
(-a-) the pharmacist is off-site and not present in the pharmacy;
(-b-) no new prescriptions may be prepared at the pharmacy but previously verified prescriptions may be delivered to the patient or the patient's agent; and
(-c-) the date/time when the pharmacist will return.
(III) the pharmacy must maintain documentation of the absences of the pharmacist(s); and
(IV) the prescription department is locked and secured to prohibit unauthorized entry.
(iv) During the time a pharmacist is absent from the prescription department and is off-site, a record of prescriptions delivered must be maintained and contain the following information:
(I) date and time of the delivery;
(II) unique identification number of the prescription drug order;
(III) patient's name;
(IV) patient's phone number or the phone number of the person picking up the prescription; and
(V) signature of the person picking up the prescription.
(v) Any prescription delivered to a patient when a pharmacist is not on-site at the pharmacy must meet the requirements for a prescription delivered to a patient as described in subsection (c)(1)(F) of this section.
(c) Prescription dispensing and delivery.
(1) Patient counseling and provision of drug information.
(A) To optimize drug therapy, a pharmacist shall communicate to the patient or the patient's agent, information about the prescription drug or device which in the exercise of the pharmacist's professional judgment the pharmacist deems significant, such as the following:
(i) the name and description of the drug or device;
(ii) dosage form, dosage, route of administration, and duration of drug therapy;
(iii) special directions and precautions for preparation, administration, and use by the patient;
(iv) common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
(v) techniques for self monitoring of drug therapy;
(vi) proper storage;
(vii) refill information; and
(viii) action to be taken in the event of a missed dose.
(B) Such communication:
(i) shall be provided with each new prescription drug order;
(ii) shall be provided for any prescription drug order dispensed by the pharmacy on the request of the patient or patient's agent;
(iii) shall be communicated orally in person unless the patient or patient's agent is not at the pharmacy or a specific communication barrier prohibits such oral communication;
(iv) effective, June 1, 2010, shall be documented by recording the initials or identification code of the pharmacist providing the counseling in the prescription dispensing record on either the original hard-copy prescription. in the pharmacy's data processing system or in an electronic logbook; and
(v) shall be reinforced with written information relevant to the prescription and provided to the patient or patient's agent. The following is applicable concerning this written information.
(I) Written information must be in plain language designed for the consumer and printed in easily readable font size.
(II) When a compounded product is dispensed, information shall be provided for the major active ingredient(s), if available.
(III) For new drug entities, if no written information is initially available, the pharmacist is not required to provide information until such information is available, provided:
(-a-) the pharmacist informs the patient or the patient's agent that the product is a new drug entity and written information is not available;
(-b-) the pharmacist documents the fact that no written information was provided; and
(-c-) if the prescription is refilled after written information is available, such information is provided to the patient or patient's agent.
(C) Only a pharmacist may verbally provide drug information to a patient or patient's agent and answer questions concerning prescription drugs. Non-pharmacist personnel may not ask questions of a patient or patient's agent which are intended to screen and/or limit interaction with the pharmacist.
(D) Nothing in this subparagraph shall be construed as requiring a pharmacist to provide consultation when a patient or patient's agent refuses such consultation. The pharmacist shall document such refusal for consultation.
(E) In addition to the requirements of subparagraphs (A) - (D) of this paragraph, if a prescription drug order is delivered to the patient at the pharmacy, the following is applicable.
(i) So that a patient will have access to information concerning his or her prescription, a prescription may not be delivered to a patient unless a pharmacist is in the pharmacy, except as provided in subsection (b)(3) of this section.
(ii) Any prescription delivered to a patient when a pharmacist is not in the pharmacy must meet the requirements described in subparagraph (F) of this paragraph.
(iii) A Class A pharmacy shall make available for use by the public a current or updated edition of the United States Pharmacopeia Dispensing Information, Volume II (Advice to the Patient), or another source of such information designed for the consumer.
(F) In addition to the requirements of subparagraphs (A) - (D) of this paragraph, if a prescription drug order is delivered to the patient or his or her agent at the patient's residence or other designated location, the following is applicable.
(i) The information specified in subparagraph (A) of this paragraph shall be delivered with the dispensed prescription in writing.
(ii) If prescriptions are routinely delivered outside the area covered by the pharmacy's local telephone service, the pharmacy shall provide a toll-free telephone line which is answered during normal business hours to enable communication between the patient and a pharmacist.
(iii) The pharmacist shall place on the prescription container or on a separate sheet delivered with the prescription container in both English and Spanish the local and if applicable, toll-free telephone number of the pharmacy and the statement: "Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at (insert the pharmacy's local and toll-free telephone numbers)."
(iv) The pharmacy shall maintain and use adequate storage or shipment containers and use shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of appropriate packaging material and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery process.
(v) The pharmacy shall use a delivery system which is designed to assure that the drugs are delivered to the appropriate patient.
(G) Except as specified in subparagraph (B) of this paragraph, in the best interest of the public health and to optimize drug therapy, upon delivery of a refill prescription, a pharmacist shall ensure that the patient or patient's agent is offered information about the refilled prescription. Either a pharmacist or other pharmacy personnel shall inform the patient or patient's agent that a pharmacist is available to discuss the patient's prescription and provide information.
(H) A pharmacy shall post a sign no smaller than 8.5 inches by 11 inches in clear public view at all locations in the pharmacy where a patient may pick up prescriptions. The sign shall contain the following statement in a font that is easily readable: "Do you have questions about your prescription? Ask the pharmacist." Such notification shall be in both English and Spanish.
(I) The provisions of this paragraph do not apply to patients in facilities where drugs are administered to patients by a person required to do so by the laws of the state (i.e., nursing homes).
(2) Pharmaceutical care services.
(A) Drug regimen review.
(i) For the purpose of promoting therapeutic appropriateness, a pharmacist shall, prior to or at the time of dispensing a prescription drug order, review the patient's medication record. Such review shall at a minimum identify clinically significant:
(I) known allergies;
(II) rational therapy-contraindications;
(III) reasonable dose and route of administration;
(IV) reasonable directions for use;
(V) duplication of therapy;
(VI) drug-drug interactions;
(VII) drug-food interactions;
(VIII) drug-disease interactions;
(IX) adverse drug reactions; and
(X) proper utilization, including overutilization or underutilization.
(ii) Upon identifying any clinically significant conditions, situations, or items listed in clause (i) of this subparagraph, the pharmacist shall take appropriate steps to avoid or resolve the problem including consultation with the prescribing practitioner. The pharmacist shall document such occurrences.
(iii) The drug regimen review may be conducted by remotely accessing the pharmacy's electronic data base from outside the pharmacy by an individual Texas licensed pharmacist employee of the pharmacy, provided the pharmacy establishes controls to protect the privacy of the patient and the security of confidential records.
(B) Other pharmaceutical care services which may be provided by pharmacists include, but are not limited to, the following:
(i) managing drug therapy as delegated by a practitioner as allowed under the provisions of the Medical Practices;
(ii) administering immunizations and vaccinations under written protocol of a physician;
(iii) managing patient compliance programs;
(iv) providing preventative health care services; and
(v) providing case management of patients who are being treated with high-risk or high-cost drugs, or who are considered "high risk" due to their age, medical condition, family history, or related concern.
(3) Generic Substitution.
(A) General requirements.
(i) In accordance with Chapter 562 of the Act, a pharmacist may dispense a generically equivalent drug product if:
(I) the generic product costs the patient less than the prescribed drug product;
(II) the patient does not refuse the substitution; and
(III) the practitioner does not certify on the prescription form that a specific prescribed brand is medically necessary as specified in a dispensing directive described in subparagraph (C) of this paragraph.
(ii) If the practitioner has prohibited substitution through a dispensing directive in compliance with subparagraph (C) of this paragraph, a pharmacist shall not substitute a generically equivalent drug product unless the pharmacist obtains verbal or written authorization from the practitioner and notes such authorization on the original prescription drug order.
(B) Prescription format for written prescription drug orders.
(i) A written prescription drug order issued in Texas may:
(I) be on a form containing a single signature line for the practitioner; and
(II) contain the following reminder statement on the face of the prescription: "A generically equivalent drug product may be dispensed unless the practitioner hand writes the words 'Brand Necessary' or 'Brand Medically Necessary' on the face of the prescription."
(ii) A pharmacist may dispense a prescription that is not issued on the form specified in clause (i) of this subparagraph, however, the pharmacist may dispense a generically equivalent drug product unless the practitioner has prohibited substitution through a dispensing directive in compliance with subparagraph (C)(i) of this paragraph.
(iii) The prescription format specified in clause (i) of this subparagraph does not apply to the following types of prescription drug orders:
(I) prescription drug orders issued by a practitioner in a state other than Texas;
(II) prescriptions for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; or
(III) prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment.
(iv) In the event of multiple prescription orders appearing on one prescription form, the practitioner shall clearly identify to which prescription(s) the dispensing directive(s) apply. If the practitioner does not clearly indicate to which prescription(s) the dispensing directive(s) apply, the pharmacist may substitute on all prescriptions on the form.
(C) Dispensing directive.
(i) Written prescriptions.
(I) A practitioner may prohibit the substitution of a generically equivalent drug product for a brand name drug product by writing across the face of the written prescription, in the practitioner's own handwriting, the phrase "brand necessary" or "brand medically necessary."
(II) The dispensing directive shall:
(-a-) be in a format that protects confidentiality as required by the Health Insurance Portability and Accountability Act of 1996 (29 U.S.C. Section 1181 et seq.) and its subsequent amendments; and
(-b-) comply with federal and state law, including rules, with regard to formatting and security requirements.
(III) The dispensing directive specified in this paragraph may not be preprinted, rubber stamped, or otherwise reproduced on the prescription form.
(IV) After, June 1, 2002, a practitioner may prohibit substitution on a written prescription only by following the dispensing directive specified in this paragraph. Two-line prescription forms, check boxes, or other notations on an original prescription drug order which indicate "substitution instructions" are not valid methods to prohibit substitution, and a pharmacist may substitute on these types of written prescriptions.
(V) A written prescription drug order issued prior to June 1, 2002, but presented for dispensing on or after June 1, 2002, shall follow the substitution instructions on the prescription.
(ii) Verbal Prescriptions.
(I) If a prescription drug order is transmitted to a pharmacist orally, the practitioner or practitioner's agent shall prohibit substitution by specifying "brand necessary" or "brand medically necessary." The pharmacists shall note any substitution instructions by the practitioner or practitioner's agent, on the file copy of the prescription drug order. Such file copy may follow the one-line format indicated in subparagraph (B)(i) of this paragraph, or any other format that clearly indicates the substitution instructions.
(II) If the practitioner's or practitioner's agent does not clearly indicate that the brand name is medically necessary, the pharmacist may substitute a generically equivalent drug product.
(III) To prohibit substitution on a verbal prescription reimbursed through the medical assistance program specified in 42 C.F.R., §447.331:
(-a-) the practitioner or the practitioner's agent shall verbally indicate that the brand is medically necessary; and
(-b-) the practitioner shall mail or fax a written prescription to the pharmacy which complies with the dispensing directive for written prescriptions specified in clause (i) of this subparagraph within 30 days.
(iii) Electronic prescription drug orders.
(I) To prohibit substitution, the practitioner or practitioner's agent shall note "brand necessary" or "brand medically necessary" on the electronic prescription drug order.
(II) If the practitioner or practitioner's agent does not clearly indicate on the electronic prescription drug order that the brand is medically necessary, the pharmacist may substitute a generically equivalent drug product.
(III) To prohibit substitution on an electronic prescription drug order reimbursed through the medical assistance program specified in 42 C.F.R., §447.331, the practitioner shall fax a copy of the original prescription drug order which complies with the requirements of a written prescription drug order specified in clause (i) of this subparagraph within 30 days.
(iv) Prescriptions issued by out-of-state, Mexican, Canadian, or federal facility practitioners.
(I) The dispensing directive specified in this subsection does not apply to the following types of prescription drug orders:
(-a-) prescription drug orders issued by a practitioner in a state other than Texas;
(-b-) prescriptions for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; or
(-c-) prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment.
(II) A pharmacist may not substitute on prescription drug orders identified in subclause (I) of this clause unless the practitioner has authorized substitution on the prescription drug order. If the practitioner has not authorized substitution on the written prescription drug order, a pharmacist shall not substitute a generically equivalent drug product unless:
(-a-) the pharmacist obtains verbal or written authorization from the practitioner (such authorization shall be noted on the original prescription drug order); or
(-b-) the pharmacist obtains written documentation regarding substitution requirements from the State Board of Pharmacy in the state, other than Texas, in which the prescription drug order was issued. The following is applicable concerning this documentation.
(-1-) The documentation shall state that a pharmacist may substitute on a prescription drug order issued in such other state unless the practitioner prohibits substitution on the original prescription drug order.
(-2-) The pharmacist shall note on the original prescription drug order the fact that documentation from such other state board of pharmacy is on file.
(-3-) Such documentation shall be updated yearly.
(D) Refills.
(i) Original substitution instructions. All refills, including prescriptions issued prior to June 1, 2001, shall follow the original substitution instructions or dispensing directive, unless otherwise indicated by the practitioner or practitioner's agent.
(ii) Narrow therapeutic index drugs.
(I) The board, in consultation with the Texas State Board of Medical Examiners, has determined that no drugs shall be included on a list of narrow therapeutic index drugs as defined in §562.013, Occupations Code.
(-a-) The board has specified in §309.7 of this title (relating to dispensing responsibilities) that for drugs listed in the publication, pharmacists shall use as a basis for determining generic equivalency, Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication. Pharmacists may only substitute products that are rated therapeutically equivalent in the Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements.
(-b-) Practitioners may prohibit substitution through a dispensing directive in compliance with subparagraph (C) of this paragraph.
(II) The board shall reconsider the contents of the list if the Federal Food and Drug Administration determines a new equivalence classification which indicates that certain drug products are equivalent but special notification to the patient and practitioner is required when substituting these products.
(4) Substitution of dosage form.
(A) As specified in §562.002 of the Act, a pharmacist may dispense a dosage form of a drug product different from that prescribed, such as a tablet instead of a capsule or liquid instead of tablets, provided:
(i) the patient consents to the dosage form substitution;
(ii) the pharmacist notifies the practitioner of the dosage form substitution; and
(iii) the dosage form so dispensed:
(I) contains the identical amount of the active ingredients as the dosage prescribed for the patient;
(II) is not an enteric-coated or time release product;
(III) does not alter desired clinical outcomes;
(B) Substitution of dosage form may not include the substitution of a product that has been compounded by the pharmacist unless the pharmacist contacts the practitioner prior to dispensing and obtains permission to dispense the compounded product.
(5) Therapeutic Drug Interchange. A switch to a drug providing a similar therapeutic response to the one prescribed shall not be made without prior approval of the prescribing practitioner. This paragraph does not apply to generic substitution. For generic substitution, see the requirements of paragraph (3) of this subsection.
(A) The patient shall be notified of the therapeutic drug interchange prior to, or upon delivery, of the dispensed prescription to the patient. Such notification shall include:
(i) a description of the change;
(ii) the reason for the change;
(iii) whom to notify with questions concerning the change; and
(iv) instructions for return of the drug if not wanted by the patient.
(B) The pharmacy shall maintain documentation of patient notification of therapeutic drug interchange which shall include:
(i) the date of the notification;
(ii) the method of notification;
(iii) a description of the change; and
(iv) the reason for the change.
(6) Prescription containers.
(A) A drug dispensed pursuant to a prescription drug order shall be dispensed in a child-resistant container unless:
(i) the patient or the practitioner requests the prescription not be dispensed in a child-resistant container; or
(ii) the product is exempted from requirements of the Poison Prevention Packaging Act of 1970.
(B) A drug dispensed pursuant to a prescription drug order shall be dispensed in an appropriate container as specified on the manufacturer's container.
(C) Prescription containers or closures shall not be re-used. However, if a patient or patient's agent has difficulty reading or understanding a prescription label, a prescription container may be reused provided:
(i) the container is designed to provide audio-recorded information about the proper use of the prescription medication;
(ii) the container is reused for the same patient;
(iii) the container is cleaned; and
(iv) a new safety closure is used each time the prescription container is reused.
(7) Labeling.
(A) At the time of delivery of the drug, the dispensing container shall bear a label in plain language and printed in an easily readable font size with at least the following information:
(i) name, address and phone number of the pharmacy;
(ii) unique identification number of the prescription;
(iii) date the prescription is dispensed;
(iv) initials or an identification code of the dispensing pharmacist;
(v) name of the prescribing practitioner;
(vi) name of the patient or if such drug was prescribed for an animal, the species of the animal and the name of the owner;
(vii) instructions for use;
(viii) quantity dispensed;
(ix) appropriate ancillary instructions such as storage instructions or cautionary statements such as warnings of potential harmful effects of combining the drug product with any product containing alcohol;
(x) if the prescription is for a Schedules II - IV controlled substance, the statement "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed";
(xi) if the pharmacist has selected a generically equivalent drug pursuant to the provisions of the Act, Chapters 562 and 563, the statement "Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where "Brand Name" is the actual name of the brand name product prescribed;
(xii) the name of the advanced practice nurse or physician assistant, if the prescription is carried out or signed by an advanced practice nurse or physician assistant in compliance with Subtitle B, Chapter 157, Occupations Code; and
(xiii) the name and strength of the actual drug product dispensed, unless otherwise directed by the prescribing practitioner.
(I) The name shall be either:
(-a-) the brand name; or
(-b-) if no brand name, then the generic name and name of the manufacturer or distributor of such generic drug. (The name of the manufacturer or distributor may be reduced to an abbreviation or initials, provided the abbreviation or initials are sufficient to identify the manufacturer or distributor. For combination drug products or non-sterile compounded drug products having no brand name, the principal active ingredients shall be indicated on the label.)
(II) Except as provided in clause (xi) of this subparagraph, the brand name of the prescribed drug shall not appear on the prescription container label unless it is the drug product actually dispensed.
(B) The dispensing container is not required to bear the label specified in subparagraph (A) of this paragraph if:
(i) the drug is prescribed for administration to an ultimate user who is institutionalized in a licensed health care institution (e.g., nursing home, hospice, hospital);
(ii) no more than a 34-day supply or 100 dosage units, whichever is less, is dispensed at one time;
(iii) the drug is not in the possession of the ultimate user prior to administration;
(iv) the pharmacist-in-charge has determined that the institution:
(I) maintains medication administration records which include adequate directions for use for the drug(s) prescribed;
(II) maintains records of ordering, receipt, and administration of the drug(s); and
(III) provides for appropriate safeguards for the control and storage of the drug(s); and
(v) the dispensing container bears a label that adequately:
(I) identifies the:
(-a-) pharmacy by name and address;
(-b-) unique identification number of the prescription;
(-c-) name and strength of the drug dispensed;
(-d-) name of the patient;
(-e-) name of the prescribing practitioner and, if applicable, the name of the advanced practice nurse or physician assistant who signed the prescription drug order; and
(II) sets forth the directions for use and cautionary statements, if any, contained on the prescription drug order or required by law.
(d) Equipment and supplies. Class A pharmacies dispensing prescription drug orders shall have the following equipment and supplies:
(1) typewriter or comparable equipment;
(2) refrigerator;
(3) adequate supply of child-resistant, light-resistant, tight, and if applicable, glass containers;
(4) adequate supply of prescription, poison, and other applicable labels;
(5) appropriate equipment necessary for the proper preparation of prescription drug orders; and
(6) metric-apothecary weight and measure conversion charts.
(e) Library. A reference library shall be maintained which includes the following in hard-copy or electronic format:
(1) current copies of the following:
(A) Texas Pharmacy Act and rules;
(B) Texas Dangerous Drug Act and rules;
(C) Texas Controlled Substances Act and rules; and
(D) Federal Controlled Substances Act and rules (or official publication describing the requirements of the Federal Controlled Substances Act and rules);
(2) at least one current or updated reference from each of the following categories:
(A) patient information:
(i) United States Pharmacopeia Dispensing Information, Volume II (Advice to the Patient); or
(ii) a reference text or information leaflets which provide patient information;
(B) drug interactions: a reference text on drug interactions, such as Drug Interaction Facts. A separate reference is not required if other references maintained by the pharmacy contain drug interaction information including information needed to determine severity or significance of the interaction and appropriate recommendations or actions to be taken;
(C) a general information reference text, such as:
(i) Facts and Comparisons with current supplements;
(ii) United States Pharmacopeia Dispensing Information Volume I (Drug Information for the Healthcare Provider);
(iii) Clinical Pharmacology;
(iv) American Hospital Formulary Service with current supplements; or
(v) Remington's Pharmaceutical Sciences; and
(3) basic antidote information and the telephone number of the nearest Regional Poison Control Center.
(f) Drugs.
(1) Procurement and storage.
(A) The pharmacist-in-charge shall have the responsibility for the procurement and storage of drugs, but may receive input from other appropriate staff relative to such responsibility.
(B) Prescription drugs and devices and nonprescription Schedule V controlled substances shall be stored within the prescription department or a locked storage area.
(C) All drugs shall be stored at the proper temperature, as defined by the following terms:
(i) controlled room temperature--temperature maintained thermostatically between 15 degrees and 30 degrees Celsius (59 degrees and 86 degrees Fahrenheit);
(ii) cool--temperature between 8 degrees and 15 degrees Celsius (46 degrees and 59 degrees Fahrenheit) which may, alternatively, be stored in a refrigerator unless otherwise specified on the labeling;
(iii) refrigerate--temperature maintained thermostatically between 2 degrees and 8 degrees Celsius (36 degrees and 46 degrees Fahrenheit); and
(iv) freeze--temperature maintained thermostatically between -20 degrees and -10 degrees Celsius (-4 degrees and 14 degrees Fahrenheit).
(2) Out-of-date drugs or devices.
(A) Any drug or device bearing an expiration date shall not be dispensed beyond the expiration date of the drug or device.
(B) Outdated drugs or devices shall be removed from dispensing stock and shall be quarantined together until such drugs or devices are disposed of properly.
(3) Nonprescription Schedule V controlled substances.
(A) Schedule V controlled substances containing codeine, dihydrocodeine, or any of the salts of codeine or dihydrocodeine may not be distributed without a prescription drug order from a practitioner.
(B) A pharmacist may distribute nonprescription Schedule V controlled substances which contain no more than 15 milligrams of opium per 29.5729 ml or per 28.35 Gm provided:
(i) such distribution is made only by a pharmacist; a nonpharmacist employee may not distribute a nonprescription Schedule V controlled substance even if under the supervision of a pharmacist; however, after the pharmacist has fulfilled professional and legal responsibilities, the actual cash, credit transaction, or delivery may be completed by a nonpharmacist:
(ii) not more than 240 ml (eight fluid ounces), or not more than 48 solid dosage units of any substance containing opium, may be distributed to the same purchaser in any given 48-hour period without a prescription drug order;
(iii) the purchaser is at least 18 years of age; and
(iv) the pharmacist requires every purchaser not known to the pharmacist to furnish suitable identification (including proof of age where appropriate).
(C) A record of such distribution shall be maintained by the pharmacy in a bound record book. The record shall contain the following information:
(i) true name of the purchaser;
(ii) current address of the purchaser;
(iii) name and quantity of controlled substance purchased;
(iv) date of each purchase; and
(v) signature or written initials of the distributing pharmacist.
(4) Class A Pharmacies may not sell, purchase, trade or possess prescription drug samples, unless the pharmacy meets all of the following conditions:
(A) the pharmacy is owned by a charitable organization described in the Internal Revenue Code of 1986, or by a city, state or county government;
(B) the pharmacy is a part of a health care entity which provides health care primarily to indigent or low income patients at no or reduced cost;
(C) the samples are for dispensing or provision at no charge to patients of such health care entity; and
(D) the samples are possessed in compliance with the federal Prescription Drug Marketing Act of 1986.
(g) Prepackaging of drugs.
(1) Drugs may be prepackaged in quantities suitable for internal distribution only by a pharmacist or by supportive personnel under the direction and direct supervision of a pharmacist.
(2) The label of a prepackaged unit shall indicate:
(A) brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor;
(B) facility's lot number;
(C) expiration date; and
(D) quantity of the drug, if the quantity is greater than one.
(3) Records of prepackaging shall be maintained to show:
(A) name of the drug, strength, and dosage form;
(B) facility's lot number;
(C) manufacturer or distributor;
(D) manufacturer's lot number;
(E) expiration date;
(F) quantity per prepackaged unit;
(G) number of prepackaged units;
(H) date packaged;
(I) name, initials, or electronic signature of the prepacker; and
(J) signature, or electronic signature of the responsible pharmacist.
(4) Stock packages, repackaged units, and control records shall be quarantined together until checked/released by the pharmacist.
(h) Customized patient medication packages.
(1) Purpose. In lieu of dispensing two or more prescribed drug products in separate containers, a pharmacist may, with the consent of the patient, the patient's caregiver, or the prescriber, provide a customized patient medication package (patient med-pak).
(2) Definition. A patient med-pak is a package prepared by a pharmacist for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. The patient med-pak is so designed or each container is so labeled as to indicate the day and time, or period of time, that the contents within each container are to be taken.
(3) Label.
(A) The patient med-pak shall bear a label stating:
(i) the name of the patient;
(ii) the unique identification number for the patient med-pak itself and a separate unique identification number for each of the prescription drug orders for each of the drug products contained therein;
(iii) the name, strength, physical description or identification, and total quantity of each drug product contained therein;
(iv) the directions for use and cautionary statements, if any, contained in the prescription drug order for each drug product contained therein;
(v) if applicable, a warning of the potential harmful effect of combining any form of alcoholic beverage with any drug product contained therein;
(vi) any storage instructions or cautionary statements required by the official compendia;
(vii) the name of the prescriber of each drug product;
(viii) the date of preparation of the patient med-pak and the beyond-use date assigned to the patient med-pak (which such beyond-use date shall not be later than 60 days from the date of preparation);
(ix) the name, address, and telephone number of the pharmacy;
(x) the initials or an identification code of the dispensing pharmacist; and
(xi) any other information, statements, or warnings required for any of the drug products contained therein.
(B) If the patient med-pak allows for the removal or separation of the intact containers therefrom, each individual container shall bear a label identifying each of the drug product contained therein.
(C) The dispensing container is not required to bear the label specified in subparagraph (A) of this paragraph if:
(i) the drug is prescribed for administration to an ultimate user who is institutionalized in a licensed health care institution (e.g., nursing home, hospice, hospital);
(ii) no more than a 34-day supply or 100 dosage units, whichever is less, is dispensed at one time;
(iii) the drug is not in the possession of the ultimate user prior to administration;
(iv) the pharmacist-in-charge has determined that the institution:
(I) maintains medication administration records which include adequate directions for use for the drug(s) prescribed;
(II) maintains records of ordering, receipt, and administration of the drug(s); and
(III) provides for appropriate safeguards for the control and storage of the drug(s); and
(v) the dispensing container bears a label that adequately:
(I) identifies the:
(-a-) pharmacy by name and address;
(-b-) unique identification number of the prescription;
(-c-) name and strength of each drug product dispensed;
(-d-) name of the patient;
(-e-) name of the prescribing practitioner of each drug product and if applicable, the name of the advanced practice nurse or physician assistant who signed the prescription drug order; and
(II) for each drug product sets forth the directions for use and cautionary statements, if any, contained on the prescription drug order or required by law.
(4) Labeling. The patient med-pak shall be accompanied by a patient package insert, in the event that any drug contained therein is required to be dispensed with such insert as accompanying labeling. Alternatively, such required information may be incorporated into a single, overall educational insert provided by the pharmacist for the total patient med-pak.
(5) Packaging. In the absence of more stringent packaging requirements for any of the drug products contained therein, each container of the patient med-pak shall comply with official packaging standards. Each container shall be either not reclosable or so designed as to show evidence of having been opened.
(6) Guidelines. It is the responsibility of the dispensing pharmacist when preparing a patient med-pak, to take into account any applicable compendial requirements or guidelines and the physical and chemical compatibility of the dosage forms placed within each container, as well as any therapeutic incompatibilities that may attend the simultaneous administration of the drugs.
(7) Recordkeeping. In addition to any individual prescription filing requirements, a record of each patient med-pak shall be made and filed. Each record shall contain, as a minimum:
(A) the name and address of the patient;
(B) the unique identification number for the patient med-pak itself and a separate unique identification number for each of the prescription drug orders for each of the drug products contained therein;
(C) the name of the manufacturer or distributor and lot number for each drug product contained therein;
(D) information identifying or describing the design, characteristics, or specifications of the patient med-pak sufficient to allow subsequent preparation of an identical patient med-pak for the patient;
(E) the date of preparation of the patient med-pak and the beyond-use date that was assigned;
(F) any special labeling instructions; and
(G) the initials or an identification code of the dispensing pharmacist.
(i) Automated devices and systems.
(1) Automated compounding or counting devices. If a pharmacy uses automated compounding or counting devices:
(A) the pharmacy shall have a method to calibrate and verify the accuracy of the automated compounding or counting device and document the calibration and verification on a routine basis;
(B) the devices may be loaded with bulk or unlabeled drugs only by a pharmacist or by pharmacy technicians under the direction and direct supervision of a pharmacist;
(C) the label of an automated compounding or counting device container shall indicate the brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor;
(D) records of loading bulk or unlabeled drugs into an automated compounding or counting device shall be maintained to show:
(i) name of the drug, strength, and dosage form;
(ii) manufacturer or distributor;
(iii) manufacturer's lot number;
(iv) expiration date;
(v) date of loading;
(vi) name, initials, or electronic signature of the person loading the automated compounding or counting device; and
(vii) signature or electronic signature of the responsible pharmacist; and
(E) the automated compounding or counting device shall not be used until a pharmacist verifies that the system is properly loaded and affixes his or her signature to the record specified in subparagraph (D) of this paragraph.
(2) Automated pharmacy dispensing systems. This paragraph becomes effective September 1, 2000.
(A) Authority to use automated pharmacy dispensing systems. A pharmacy may use an automated pharmacy dispensing system to fill prescription drug orders provided that:
(i) the pharmacist-in-charge is responsible for the supervision of the operation of the system;
(ii) the automated pharmacy dispensing system has been tested by the pharmacy and found to dispense accurately. The pharmacy shall make the results of such testing available to the Board upon request; and
(iii) the pharmacy will make the automated pharmacy dispensing system available for inspection by the board for the purpose of validating the accuracy of the system.
(B) Quality assurance program. A pharmacy which uses an automated pharmacy dispensing system to fill prescription drug orders shall operate according to a written program for quality assurance of the automated pharmacy dispensing system which:
(i) requires continuous monitoring of the automated pharmacy dispensing system; and
(ii) establishes mechanisms and procedures to test the accuracy of the automated pharmacy dispensing system at least every six months and whenever any upgrade or change is made to the system and documents each such activity.
(C) Policies and procedures of operation.
(i) When an automated pharmacy dispensing system is used to fill prescription drug orders, it shall be operated according to written policies and procedures of operation. The policies and procedures of operation shall establish requirements for operation of the automated pharmacy dispensing system and shall describe policies and procedures that:
(I) include a description of the policies and procedures of operation;
(II) provide for a pharmacist's review, approval, and accountability for the transmission of each original or new prescription drug order to the automated pharmacy dispensing system before the transmission is made;
(III) provide for access to the automated pharmacy dispensing system for stocking and retrieval of medications which is limited to licensed healthcare professionals or pharmacy technicians acting under the supervision of a pharmacist;
(IV) require prior to use, that a pharmacist checks, verifies, and documents that the automated pharmacy dispensing system has been accurately filled each time the system is stocked;
(V) provide for an accountability record to be maintained which documents all transactions relative to stocking and removing medications from the automated pharmacy dispensing system;
(VI) require a prospective drug regimen review is conducted as specified in subsection (c)(2) of this section; and
(VII) establish and make provisions for documentation of a preventative maintenance program for the automated pharmacy dispensing system.
(ii) A pharmacy which uses an automated pharmacy dispensing system to fill prescription drug orders shall, at least annually, review its written policies and procedures, revise them if necessary, and document the review.
(D) Recovery Plan. A pharmacy which uses an automated pharmacy dispensing system to fill prescription drug orders shall maintain a written plan for recovery from a disaster or any other situation which interrupts the ability of the automated pharmacy dispensing system to provide services necessary for the operation of the pharmacy. The written plan for recovery shall include:
(i) planning and preparation for maintaining pharmacy services when an automated pharmacy dispensing system is experiencing downtime;
(ii) procedures for response when an automated pharmacy dispensing system is experiencing downtime;
(iii) procedures for the maintenance and testing of the written plan for recovery; and
(iv) procedures for notification of the Board, each patient of the pharmacy, and other appropriate agencies whenever an automated pharmacy dispensing system experiences downtime for more than two days of operation or a period of time which significantly limits the pharmacy's ability to provide pharmacy services.
(3) Final check of prescriptions dispensed using an automated pharmacy dispensing system. For the purpose of §291.32(b)(2) of this title, a pharmacist must perform the final check of all prescriptions prior to delivery to the patient to ensure that the prescription is dispensed accurately as prescribed.
(A) This final check shall be considered accomplished if:
(i) a check of the final product is conducted by a pharmacist after the automated system has completed the prescription and prior to delivery to the patient; or
(ii) the following checks are conducted by a pharmacist:
(I) if the automated pharmacy dispensing system contains bulk stock drugs, a pharmacist verifies that those drugs have been accurately stocked as specified in paragraph (2)(C)(i)(IV) of this subsection; and
(II) a pharmacist checks the accuracy of the data entry of each original or new prescription drug order entered into the automated pharmacy dispensing system.
(B) If the final check is accomplished as specified in subparagraph (A)(ii) of this paragraph, the following additional requirements must be met.
(i) The dispensing process must be fully automated from the time the pharmacist releases the prescription to the automated system until a completed, labeled prescription ready for delivery to the patient is produced.
(ii) The pharmacy has conducted initial testing and has a continuous quality assurance program which documents that the automated pharmacy dispensing system dispenses accurately as specified in paragraph (2)(A) and (B) of this subsection.
(iii) The automated pharmacy dispensing system documents and maintains:
(I) the name(s), initials, or identification code(s) of each pharmacist responsible for the checks outlined in subparagraph (A)(ii) of this paragraph; and
(II) the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who performs any other portion of the dispensing process.
(iv) The pharmacy establishes mechanisms and procedures to test the accuracy of the automated pharmacy dispensing system at least every month rather than every six months as specified in paragraph (2)(B) of this subsection.
(4) Automated checking device.
(A) For the purpose of this subsection, an automated checking device is a fully automated device which confirms, after dispensing but prior to delivery to the patient, that the correct drug and strength has been labeled with the correct label for the correct patient.
(B) For the purpose of §291.32(b)(2) of this title, the final check of a dispensed prescription shall be considered accomplished using an automated checking device provided:
(i) a check of the final product is conducted by a pharmacist prior to delivery to the patient or the following checks are performed by a pharmacist:
(I) the prepackaged drug used to fill the order is checked by a pharmacist who verifies that the drug is labeled and packaged accurately; and
(II) a pharmacist checks the accuracy of each original or new prescription drug order.
(ii) the prescription is dispensed, labeled, and made ready for delivery to the patient in compliance with Class A (Community) Pharmacy rules; and
(iii) prior to delivery to the patient:
(I) the automated checking device confirms that the correct drug and strength has been labeled with the correct label for the correct patient; and
(II) a pharmacist performs all other duties required to ensure that the prescription has been dispensed safely and accurately as prescribed.
(C) If the final check is accomplished as specified in subparagraph (B) of this paragraph, the following additional requirements must be met.
(i) The pharmacy has conducted initial testing of the automated checking device and has a continuous quality assurance program which documents that the automated checking device accurately confirms that the correct drug and strength has been labeled with the correct label for the correct patient.
(ii) The pharmacy documents and maintains:
(I) the name(s), initials, or identification code(s) of each pharmacist responsible for the checks outlined in subparagraph (B)(i) of this paragraph; and
(II) the name(s) initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who perform any other portion of the dispensing process.
(iii) The pharmacy establishes mechanisms and procedures to test the accuracy of the automated checking device at least monthly.
§291.34.Records.
(a) Maintenance of records.
(1) Every inventory or other record required to be kept under the provisions of §291.31 of this title (relating to Definitions), §291.32 of this title (relating to Personnel), §291.33 of this title (relating to Operational Standards), §291.34 of this title (relating to Records), and §291.35 of this title (relating to Official Prescription Requirements), contained in Community Pharmacy (Class A) shall be:
(A) kept by the pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and
(B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in a mutually agreeable electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(2) Records of controlled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy.
(3) Records of controlled substances, other than prescription drug orders, listed in Schedules III - V shall be maintained separately or readily retrievable from all other records of the pharmacy. For purposes of this subsection, readily retrievable means that the controlled substances shall be asterisked, red-lined, or in some other manner readily identifiable apart from all other items appearing on the record.
(4) Records, except when specifically required to be maintained in original or hard-copy form, may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:
(A) the records maintained in the alternative system contain all of the information required on the manual record; and
(B) the data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.
(b) Prescriptions.
(1) Professional responsibility.
(A) Pharmacists shall exercise sound professional judgment with respect to the accuracy and authenticity of any prescription drug order they dispense. If the pharmacist questions the accuracy or authenticity of a prescription drug order, he/she shall verify the order with the practitioner prior to dispensing.
(B) Prior to dispensing a prescription, pharmacists shall determine, in the exercise of sound professional judgment, that the prescription is a valid prescription. A pharmacist may not dispense a prescription drug if the pharmacist knows or should have known that the prescription was issued on the basis of an Internet-based or telephonic consultation without a valid patient-practitioner relationship.
(C) Subparagraph (B) of this paragraph does not prohibit a pharmacist from dispensing a prescription when a valid patient-practitioner relationship is not present in an emergency situation (e.g. a practitioner taking calls for the patient's regular practitioner).
(2) Written prescription drug orders.
(A) Practitioner's signature.
(i) Except as noted in clause (ii) of this subparagraph, written prescription drug orders shall be:
(I) manually signed by the practitioner; or
(II) electronically signed by the practitioner using a system which electronically replicates the practitioner's manual signature on the written prescription, provided:
(-a-) that security features of the system require the practitioner to authorize each use; and
(-b-) the prescription is printed on paper that is designed to prevent unauthorized copying of a completed prescription and to prevent the erasure or modification of information written on the prescription by the prescribing practitioner. (For example, the paper contains security provisions against copying that results in some indication on the copy that it is a copy and therefore render the prescription null and void.)
(ii) Prescription drug orders for Schedule II controlled substances shall be issued on an official prescription form as required by the Texas Controlled Substances Act, §481.075, and be manually signed by the practitioner.
(iii) A practitioner may sign a prescription drug order in the same manner as he would sign a check or legal document, e.g. J.H. Smith or John H. Smith.
(iv) Rubber stamped or otherwise reproduced signatures may not be used except as authorized in clause (i) of this subparagraph.
(v) The prescription drug order may not be signed by a practitioner's agent but may be prepared by an agent for the signature of a practitioner. However, the prescribing practitioner is responsible in case the prescription drug order does not conform in all essential respects to the law and regulations.
(B) Prescription drug orders written by practitioners in another state.
(i) Dangerous drug prescription orders. A pharmacist may dispense a prescription drug order for dangerous drugs issued by practitioners in a state other than Texas in the same manner as prescription drug orders for dangerous drugs issued by practitioners in Texas are dispensed.
(ii) Controlled substance prescription drug orders.
(I) A pharmacist may dispense prescription drug order for controlled substances in Schedule II issued by a practitioner in another state provided:
(-a-) the prescription is filled in compliance with a written plan approved by the Director of the Texas Department of Public Safety in consultation with the Board, which provides the manner in which the dispensing pharmacy may fill a prescription for a Schedule II controlled substance;
(-b-) the prescription drug order is an original written prescription issued by a person practicing in another state and licensed by another state as a physician, dentist, veterinarian, or podiatrist, who has a current federal Drug Enforcement Administration (DEA) registration number, and who may legally prescribe Schedule II controlled substances in such other state; and
(-c-) the prescription drug order is not dispensed after the end of the seventh day after the date on which the prescription is issued.
(II) A pharmacist may dispense prescription drug orders for controlled substances in Schedule III, IV, or V issued by a physician, dentist, veterinarian, or podiatrist in another state provided:
(-a-) the prescription drug order is a written, oral, or telephonically or electronically communicated prescription, as allowed by the DEA issued by a person practicing in another state and licensed by another state as a physician, dentist, veterinarian, or podiatrist, who has a current federal DEA registration number, and who may legally prescribe Schedule III, IV, or V controlled substances in such other state;
(-b-) the prescription drug order is not dispensed or refilled more than six months from the initial date of issuance and may not be refilled more than five times; and
(-c-) if there are no refill instructions on the original prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original prescription drug order have been dispensed, a new prescription drug order is obtained from the prescribing practitioner prior to dispensing any additional quantities of controlled substances.
(C) Prescription drug orders written by practitioners in the United Mexican States or the Dominion of Canada.
(i) Controlled substance prescription drug orders. A pharmacist may not dispense a prescription drug order for a Schedule II, III, IV, or V controlled substance issued by a practitioner in the Dominion of Canada or the United Mexican States.
(ii) Dangerous drug prescription drug orders. A pharmacist may dispense a dangerous drug prescription issued by a person licensed in the Dominion of Canada or the United Mexican States as a physician, dentist, veterinarian, or podiatrist provided:
(I) the prescription drug order is an original written prescription; and
(II) if there are no refill instructions on the original written prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original written prescription drug order have been dispensed, a new written prescription drug order shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of dangerous drugs.
(D) Prescription drug orders carried out or signed by an advanced practice nurse or physician assistant.
(i) A pharmacist may dispense a prescription drug order which is carried out or signed by an advanced practice nurse or physician assistant provided the advanced practice nurse or physician assistant is practicing in accordance with Subtitle B, Chapter 157, Occupations Code.
(ii) Each practitioner shall designate in writing the name of each advanced practice nurse or physician assistant authorized to carry out or sign a prescription drug order pursuant to Subtitle B, Chapter 157, Occupations Code. A list of the advanced practice nurses or physician assistants designated by the practitioner must be maintained in the practitioner's usual place of business. On request by a pharmacist, a practitioner shall furnish the pharmacist with a copy of the written authorization for a specific advanced practice nurse or physician assistant.
(E) Prescription drug orders for Schedule II controlled substances. No Schedule II controlled substance may be dispensed without a written prescription drug order of a practitioner on an official prescription form as required by the Texas Controlled Substances Act, §481.075.
(3) Verbal prescription drug orders.
(A) A verbal prescription drug order from a practitioner or a practitioner's designated agent may only be received by a pharmacist or a pharmacist-intern under the direct supervision of a pharmacist.
(B) A practitioner shall designate in writing the name of each agent authorized by the practitioner to communicate prescriptions verbally for the practitioner. The practitioner shall maintain at the practitioner's usual place of business a list of the designated agents. The practitioner shall provide a pharmacist with a copy of the practitioner's written authorization for a specific agent on the pharmacist's request.
(C) A pharmacist may not dispense a verbal prescription drug order for a dangerous drug or a controlled substance issued by a practitioner licensed in the Dominion of Canada or the United Mexican States unless the practitioner is also licensed in Texas.
(4) Electronic prescription drug orders. For the purpose of this subsection, prescription drug orders shall be considered the same as verbal prescription drug orders.
(A) An electronic prescription drug order may be transmitted by a practitioner or a practitioner's designated agent:
(i) directly to a pharmacy; or
(ii) through the use of a data communication device provided:
(I) the confidential prescription information is not altered during transmission; and
(II) confidential patient information is not accessed or maintained by the operator of the data communication device other than for legal purposes under federal and state law.
(B) A practitioner shall designate in writing the name of each agent authorized by the practitioner to electronically transmit prescriptions for the practitioner. The practitioner shall maintain at the practitioner's usual place of business a list of the designated agents. The practitioner shall provide a pharmacist with a copy of the practitioner's written authorization for a specific agent on the pharmacist's request.
(C) A pharmacist may not dispense an electronic prescription drug order for a:
(i) Schedule II controlled substance, except as authorized for faxed prescriptions in §481.074, Health and Safety Code; or
(ii) dangerous drug or controlled substance issued by a practitioner licensed in the Dominion of Canada or the United Mexican States unless the practitioner is also licensed in Texas.
(5) Original prescription drug order records.
(A) Original prescriptions shall be maintained by the pharmacy in numerical order and remain legible for a period of two years from the date of filling or the date of the last refill dispensed.
(B) If an original prescription drug order is changed, such prescription order shall be invalid and of no further force and effect; if additional drugs are to be dispensed, a new prescription drug order with a new and separate number is required.
(C) Original prescriptions shall be maintained in three separate files as follows:
(i) prescriptions for controlled substances listed in Schedule II;
(ii) prescriptions for controlled substances listed in Schedules III - V; and
(iii) prescriptions for dangerous drugs and nonprescription drugs.
(D) Original prescription records other than prescriptions for Schedule II controlled substances may be stored on microfilm, microfiche, or other system which is capable of producing a direct image of the original prescription record, e.g., digitalized imaging system. If original prescription records are stored in a direct imaging system, the following is applicable:
(i) the record of refills recorded on the original prescription must also be stored in this system;
(ii) the original prescription records must be maintained in numerical order and separated in three files as specified in subparagraph (C) of this paragraph; and
(iii) the pharmacy must provide immediate access to equipment necessary to render the records easily readable.
(6) Prescription drug order information.
(A) All original prescriptions shall bear:
(i) name of the patient, or if such drug is for an animal, the species of such animal and the name of the owner;
(ii) address of the patient, provided, however, a prescription for a dangerous drug is not required to bear the address of the patient if such address is readily retrievable on another appropriate, uniformly maintained pharmacy record, such as medication records;
(iii) name, and if for a controlled substance, the address and DEA registration number of the practitioner;
(iv) name and strength of the drug prescribed;
(v) quantity prescribed;
(vi) directions for use;
(vii) intended use for the drug unless the practitioner determines the furnishing of this information is not in the best interest of the patient; and
(viii) date of issuance.
(B) All original electronic prescription drug orders shall bear:
(i) name of the patient, if such drug is for an animal, the species of such animal, and the name of the owner;
(ii) address of the patient, provided, however, a prescription for a dangerous drug is not required to bear the address of the patient if such address is readily retrievable on another appropriate, uniformly maintained pharmacy record, such as medication records;
(iii) name, and if for a controlled substance, the address and DEA registration number of the practitioner;
(iv) name and strength of the drug prescribed;
(v) quantity prescribed;
(vi) directions for use;
(vii) indications for use, unless the practitioner determines the furnishing of this information is not in the best interest of the patient;
(viii) date of issuance;
(ix) a statement which indicates that the prescription has been electronically transmitted (e.g., Faxed to or electronically transmitted to:);
(x) name, address, and electronic access number of the pharmacy to which the prescription was transmitted;
(xi) telephone number of the prescribing practitioner;
(xii) date the prescription drug order was electronically transmitted to the pharmacy, if different from the date of issuance of the prescription; and
(xiii) if transmitted by a designated agent, the full name of the designated agent.
(C) All original written prescriptions carried out or signed by an advanced practice nurse or physician assistant in accordance with Subtitle B, Chapter 157, Occupations Code, shall bear:
(i) name and address of the patient;
(ii) name, address, telephone number, and if the prescription is for a controlled substance, the DEA number of the supervising practitioner;
(iii) name, identification number, original signature and if the prescription is for a controlled substance, the DEA number of the advanced practice nurse or physician assistant;
(iv) address and telephone number of the clinic at which the prescription drug order was carried out or signed;
(v) name, strength, and quantity of the drug;
(vi) directions for use;
(vii) indications for use, if appropriate;
(viii) date of issuance; and
(ix) number of refills authorized.
(D) At the time of dispensing, a pharmacist is responsible for documenting the following information on either the original hard-copy prescription or in the pharmacy's data processing system:
(i) unique identification number of the prescription drug order;
(ii) initials or identification code of the dispensing pharmacist;
(iii) effective January 1, 2009, initials or identification code of the pharmacy technician or pharmacy technician trainee performing data entry of the prescription, if applicable;
(iv) quantity dispensed, if different from the quantity prescribed;
(v) date of dispensing, if different from the date of issuance;
(vi) brand name or manufacturer of the drug product actually dispensed, if the drug was prescribed by generic name or if a drug product other than the one prescribed was dispensed pursuant to the provisions of the Act, Chapters 562 and 563; and
(vii) effective June 1, 2010, for each new prescription the initials or identification code of the pharmacist responsible for providing counseling.
(7) Refills.
(A) Refills may be dispensed only in accordance with the prescriber's authorization as indicated on the original prescription drug order.
(B) If there are no refill instructions on the original prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original prescription drug order have been dispensed, authorization from the prescribing practitioner shall be obtained prior to dispensing any refills.
(C) Refills of prescription drug orders for dangerous drugs or nonprescription drugs.
(i) Prescription drug orders for dangerous drugs or nonprescription drugs may not be refilled after one year from the date of issuance of the original prescription drug order.
(ii) If one year has expired from the date of issuance of an original prescription drug order for a dangerous drug or nonprescription drug, authorization shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of the drug.
(D) Refills of prescription drug orders for Schedules III - V controlled substances.
(i) Prescription drug orders for Schedules III - V controlled substances may not be refilled more than five times or after six months from the date of issuance of the original prescription drug order, whichever occurs first.
(ii) If a prescription drug order for a Schedule III, IV, or V controlled substance has been refilled a total of five times or if six months have expired from the date of issuance of the original prescription drug order, whichever occurs first, a new and separate prescription drug order shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of controlled substances.
(E) If a pharmacist is unable to contact the prescribing practitioner after a reasonable effort, a pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided:
(i) failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering;
(ii) the quantity of prescription drug dispensed does not exceed a 72-hour supply;
(iii) the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills;
(iv) the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time;
(v) the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection;
(vi) the pharmacist affixes a label to the dispensing container as specified in §291.33(c)(7) of this title; and
(vii) if the prescription was initially filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided:
(I) the patient has the prescription container, label, receipt or other documentation from the other pharmacy which contains the essential information;
(II) after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription;
(III) the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of clause (i) of this subparagraph; and
(IV) the pharmacist complies with the requirements of clauses (ii) - (vi) of this subparagraph.
(F) If a natural or manmade disaster has occurred that prohibits the pharmacist from being able to contact the practitioner, a pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided:
(i) failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering;
(ii) the quantity of prescription drug dispensed does not exceed a 30-day supply;
(iii) the governor has declared a state of disaster;
(iv) the board, through the executive director, has notified pharmacies that pharmacists may dispense up to a 30-day supply of prescription drugs;
(v) the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills;
(vi) the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time;
(vii) the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection;
(viii) the pharmacist affixes a label to the dispensing container as specified in §291.33(c)(7) of this title; and
(ix) if the prescription was initially filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided:
(I) the patient has the prescription container, label, receipt or other documentation from the other pharmacy which contains the essential information;
(II) after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription;
(III) the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of clause (i) of this subparagraph; and
(IV) the pharmacist complies with the requirements of clauses (ii) - (viii) of this subparagraph.
(c) Patient medication records.
(1) A patient medication record system shall be maintained by the pharmacy for patients to whom prescription drug orders are dispensed.
(2) The patient medication record system shall provide for the immediate retrieval of information for the previous 12 months which is necessary for the dispensing pharmacist to conduct a prospective drug regimen review at the time a prescription drug order is presented for dispensing.
(3) The pharmacist-in-charge shall assure that a reasonable effort is made to obtain and record in the patient medication record at least the following information:
(A) full name of the patient for whom the drug is prescribed;
(B) address and telephone number of the patient;
(C) patient's age or date of birth;
(D) patient's gender;
(E) any known allergies, drug reactions, idiosyncrasies, and chronic conditions or disease states of the patient and the identity of any other drugs currently being used by the patient which may relate to prospective drug regimen review;
(F) pharmacist's comments relevant to the individual's drug therapy, including any other information unique to the specific patient or drug; and
(G) a list of all prescription drug orders dispensed (new and refill) to the patient by the pharmacy during the last two years. Such list shall contain the following information:
(i) date dispensed;
(ii) name, strength, and quantity of the drug dispensed;
(iii) prescribing practitioner's name;
(iv) unique identification number of the prescription; and
(v) name or initials of the dispensing pharmacists.
(4) A patient medication record shall be maintained in the pharmacy for two years. If patient medication records are maintained in a data processing system, all of the information specified in this subsection shall be maintained in a retrievable form for two years and information for the previous 12 months shall be maintained on-line. Effective January 1, 2009, a patient medication record must contain documentation of any modification, change, or manipulation to a patient profile.
(5) Nothing in this paragraph shall be construed as requiring a pharmacist to obtain, record, and maintain patient information other than prescription drug order information when a patient or patient's agent refuses to provide the necessary information for such patient medication records.
(d) Prescription drug order records maintained in a manual system.
(1) Original prescriptions shall be maintained in three files as specified in subsection (b)(5)(C) of this section.
(2) Refills.
(A) Each time a prescription drug order is refilled, a record of such refill shall be made:
(i) on the back of the prescription by recording the date of dispensing, the written initials or identification code of the dispensing pharmacist, effective January 1, 2009, the initials or identification code of the pharmacy technician or pharmacy technician trainee preparing the prescription label, if applicable, and the amount dispensed. (If the pharmacist merely initials and dates the back of the prescription drug order, he or she shall be deemed to have dispensed a refill for the full face amount of the prescription drug order); or
(ii) on another appropriate, uniformly maintained, readily retrievable record, such as medication records, which indicates by patient name the following information:
(I) unique identification number of the prescription;
(II) name and strength of the drug dispensed;
(III) date of each dispensing;
(IV) quantity dispensed at each dispensing;
(V) initials or identification code of the dispensing pharmacist;
(VI) effective January 1, 2009, initials or identification code of the pharmacy technician or pharmacy technician trainee preparing the prescription label, if applicable; and
(VII) total number of refills for the prescription.
(B) If refill records are maintained in accordance with subparagraph (A)(ii) of this paragraph, refill records for controlled substances in Schedules III - V shall be maintained separately from refill records of dangerous drugs and nonprescription drugs.
(3) Authorization of refills. Practitioner authorization for additional refills of a prescription drug order shall be noted on the original prescription, in addition to the documentation of dispensing the refill.
(4) Transfer of prescription drug order information. For the purpose of refill or initial dispensing, the transfer of original prescription drug order information is permissible between pharmacies, subject to the following requirements:
(A) the transfer of original prescription drug order information for controlled substances listed in Schedule III, IV, or V is permissible between pharmacies on a one-time basis;
(B) the transfer of original prescription drug order information for dangerous drugs is permissible between pharmacies without limitation up to the number of originally authorized refills;
(C) the transfer is communicated directly between pharmacists and/or pharmacist interns;
(D) both the original and the transferred prescription drug order are maintained for a period of two years from the date of last refill;
(E) the pharmacist or pharmacist intern transferring the prescription drug order information shall:
(i) write the word "void" on the face of the invalidated prescription drug order; and
(ii) record on the reverse of the invalidated prescription drug order the following information:
(I) the name, address, and if a controlled substance, the DEA registration number of the pharmacy to which such prescription drug order is transferred;
(II) the name of the pharmacist or pharmacist intern receiving the prescription drug order information;
(III) the name of the pharmacist or pharmacist intern transferring the prescription drug order information; and
(IV) the date of the transfer;
(F) the pharmacist or pharmacist intern receiving the transferred prescription drug order information shall:
(i) write the word "transfer" on the face of the transferred prescription drug order; and
(ii) record on the transferred prescription drug order the following information:
(I) original date of issuance and date of dispensing or receipt, if different from date of issuance;
(II) original prescription number and the number of refills authorized on the original prescription drug order;
(III) number of valid refills remaining and the date of last refill, if applicable;
(IV) name, address, and if a controlled substance, the DEA registration number of the pharmacy from which such prescription information is transferred; and
(V) name of the pharmacist or pharmacist intern transferring the prescription drug order information.
(5) A pharmacist or pharmacist intern may not refuse to transfer original prescription information to another pharmacist or pharmacist intern who is acting on behalf of a patient and who is making a request for this information as specified in paragraph (4) of this subsection.
(6) Effective January 1, 2009, each time a modification, change, or manipulation is made to a record of dispensing, documentation of such change shall be recorded on the back of the prescription or on another appropriate, uniformly maintained, readily retrievable record, such as medication records. The documentation of any modification, change, or manipulation to a record of dispensing shall include the identification of the individual responsible for the alteration.
(e) Prescription drug order records maintained in a data processing system.
(1) General requirements for records maintained in a data processing system.
(A) Compliance with data processing system requirements. If a Class A (community) pharmacy's data processing system is not in compliance with this subsection, the pharmacy must maintain a manual recordkeeping system as specified in subsection (d) of this section.
(B) Original prescriptions. Original prescriptions shall be maintained in three files as specified in subsection (b)(5)(C) of this section.
(C) Requirements for backup systems.
(i) The pharmacy shall maintain a backup copy of information stored in the data processing system using disk, tape, or other electronic backup system and update this backup copy on a regular basis, at least monthly, to assure that data is not lost due to system failure.
(ii) Data processing systems shall have a workable (electronic) data retention system which can produce an audit trail of drug usage for the preceding two years as specified in paragraph (2)(G) of this subsection.
(D) Change or discontinuance of a data processing system.
(i) Records of dispensing. A pharmacy that changes or discontinues use of a data processing system must:
(I) transfer the records of dispensing to the new data processing system; or
(II) purge the records of dispensing to a printout which contains the same information required on the daily printout as specified in paragraph (2)(B) of this subsection. The information on this hard-copy printout shall be sorted and printed by prescription number and list each dispensing for this prescription chronologically.
(ii) Other records. A pharmacy that changes or discontinues use of a data processing system must:
(I) transfer the records to the new data processing system; or
(II) purge the records to a printout which contains all of the information required on the original document.
(iii) Maintenance of purged records. Information purged from a data processing system must be maintained by the pharmacy for two years from the date of initial entry into the data processing system.
(E) Loss of data. The pharmacist-in-charge shall report to the board in writing any significant loss of information from the data processing system within 10 days of discovery of the loss.
(2) Records of dispensing.
(A) Each time a prescription drug order is filled or refilled, a record of such dispensing shall be entered into the data processing system.
(B) Effective January 1, 2009, each time a modification, change or manipulation is made to a record of dispensing, documentation of such change shall be recorded in the data processing system. The documentation of any modification, change, or manipulation to a record of dispensing shall include the identification of the individual responsible for the alteration. Should the data processing system not be able to record a modification, change, or manipulation to a record of dispensing, the information should be clearly documented on the hardcopy prescription.
(C) The data processing system shall have the capacity to produce a daily hard-copy printout of all original prescriptions dispensed and refilled. This hard-copy printout shall contain the following information:
(i) unique identification number of the prescription;
(ii) date of dispensing;
(iii) patient name;
(iv) prescribing practitioner's name;
(v) name and strength of the drug product actually dispensed; if generic name, the brand name or manufacturer of drug dispensed;
(vi) quantity dispensed;
(vii) initials or an identification code of the dispensing pharmacist;
(viii) effective January 1, 2009, initials or an identification code of the pharmacy technician or pharmacy technician trainee performing data entry of the prescription, if applicable;
(ix) if not immediately retrievable via CRT display, the following shall also be included on the hard-copy printout:
(I) patient's address;
(II) prescribing practitioner's address;
(III) practitioner's DEA registration number, if the prescription drug order is for a controlled substance;
(IV) quantity prescribed, if different from the quantity dispensed;
(V) date of issuance of the prescription drug order, if different from the date of dispensing; and
(VI) total number of refills dispensed to date for that prescription drug order; and
(x) effective January 1, 2009, any changes made to a record of dispensing.
(D) The daily hard-copy printout shall be produced within 72 hours of the date on which the prescription drug orders were dispensed and shall be maintained in a separate file at the pharmacy. Records of controlled substances shall be readily retrievable from records of noncontrolled substances.
(E) Each individual pharmacist who dispenses or refills a prescription drug order shall verify that the data indicated on the daily hard-copy printout is correct, by dating and signing such document in the same manner as signing a check or legal document (e.g., J.H. Smith, or John H. Smith) within seven days from the date of dispensing.
(F) In lieu of the printout described in subparagraph (C) of this paragraph, the pharmacy shall maintain a log book in which each individual pharmacist using the data processing system shall sign a statement each day, attesting to the fact that the information entered into the data processing system that day has been reviewed by him or her and is correct as entered. Such log book shall be maintained at the pharmacy employing such a system for a period of two years after the date of dispensing; provided, however, that the data processing system can produce the hard-copy printout on demand by an authorized agent of the Texas State Board of Pharmacy. If no printer is available on site, the hard-copy printout shall be available within 72 hours with a certification by the individual providing the printout, which states that the printout is true and correct as of the date of entry and such information has not been altered, amended, or modified.
(G) The pharmacist-in-charge is responsible for the proper maintenance of such records and responsible that such data processing system can produce the records outlined in this section and that such system is in compliance with this subsection.
(H) The data processing system shall be capable of producing a hard-copy printout of an audit trail for all dispensings (original and refill) of any specified strength and dosage form of a drug (by either brand or generic name or both) during a specified time period.
(i) Such audit trail shall contain all of the information required on the daily printout as set out in subparagraph (C) of this paragraph.
(ii) The audit trail required in this subparagraph shall be supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy.
(I) Failure to provide the records set out in this subsection, either on site or within 72 hours constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(J) The data processing system shall provide on-line retrieval (via CRT display or hard-copy printout) of the information set out in subparagraph (C) of this paragraph of:
(i) the original controlled substance prescription drug orders currently authorized for refilling; and
(ii) the current refill history for Schedules III, IV, and V controlled substances for the immediately preceding six-month period.
(K) In the event that a pharmacy which uses a data processing system experiences system downtime, the following is applicable:
(i) an auxiliary procedure shall ensure that refills are authorized by the original prescription drug order and that the maximum number of refills has not been exceeded or authorization from the prescribing practitioner shall be obtained prior to dispensing a refill; and
(ii) all of the appropriate data shall be retained for on-line data entry as soon as the system is available for use again.
(3) Authorization of refills. Practitioner authorization for additional refills of a prescription drug order shall be noted as follows:
(A) on the hard-copy prescription drug order;
(B) on the daily hard-copy printout; or
(C) via the CRT display.
(4) Transfer of prescription drug order information. For the purpose of refill or initial dispensing, the transfer of original prescription drug order information is permissible between pharmacies, subject to the following requirements.
(A) The transfer of original prescription drug order information for controlled substances listed in Schedule III, IV, or V is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization.
(B) The transfer of original prescription drug order information for dangerous drugs is permissible between pharmacies without limitation up to the number of originally authorized refills.
(C) The transfer is communicated directly between pharmacists and/or pharmacist interns orally by telephone or via facsimile or as authorized in paragraph (5) of this subsection. A transfer completed as authorized in paragraph (5) of this subsection may be initiated by a pharmacy technician or pharmacy technician trainee acting under the direct supervision of a pharmacist.
(D) Both the original and the transferred prescription drug orders are maintained for a period of two years from the date of last refill.
(E) The pharmacist or pharmacist intern transferring the prescription drug order information shall:
(i) write the word "void" on the face of the invalidated prescription drug order; and
(ii) record on the reverse of the invalidated prescription drug order the following information:
(I) the name, address, and if a controlled substance, the DEA registration number of the pharmacy to which such prescription is transferred;
(II) the name of the pharmacist or pharmacist intern receiving the prescription drug order information;
(III) the name of the pharmacist or pharmacist intern transferring the prescription drug order information; and
(IV) the date of the transfer.
(F) The pharmacist or pharmacist intern receiving the transferred prescription drug order information shall:
(i) write the word "transfer" on the face of the transferred prescription drug order; and
(ii) record on the transferred prescription drug order the following information:
(I) original date of issuance and date of dispensing or receipt, if different from date of issuance;
(II) original prescription number and the number of refills authorized on the original prescription drug order;
(III) number of valid refills remaining and the date of last refill, if applicable;
(IV) name, address, and if a controlled substance, the DEA registration number of the pharmacy from which such prescription drug order information is transferred; and
(V) name of the pharmacist or pharmacist intern transferring the prescription drug order information.
(G) Prescription drug orders may not be transferred by non-electronic means during periods of downtime except on consultation with and authorization by a prescribing practitioner; provided however, during downtime, a hard copy of a prescription drug order may be made available for informational purposes only, to the patient, a pharmacist or pharmacist intern, and the prescription may be read to a pharmacist or pharmacist intern by telephone.
(H) The original prescription drug order shall be invalidated in the data processing system for purposes of filling or refilling, but shall be maintained in the data processing system for refill history purposes.
(I) If the data processing system has the capacity to store all the information required in subparagraphs (E) and (F) of this paragraph, the pharmacist is not required to record this information on the original or transferred prescription drug order.
(J) The data processing system shall have a mechanism to prohibit the transfer or refilling of controlled substance prescription drug orders which have been previously transferred.
(5) Electronic transfer of prescription drug order information between pharmacies. Pharmacies electronically accessing the same prescription drug order records may electronically transfer prescription information if the following requirements are met.
(A) The original prescription is voided and the following information is documented in the records of the transferring pharmacy:
(i) the name, address, and if a controlled substance, the DEA registration number of the pharmacy to which such prescription is transferred;
(ii) the name of the pharmacist or pharmacist intern receiving the prescription drug order information; and
(iii) the date of the transfer.
(B) Pharmacies not owned by the same person may electronically access the same prescription drug order records, provided the owner or chief executive officer of each pharmacy signs an agreement allowing access to such prescription drug order records.
(C) An electronic transfer between pharmacies may be initiated by a pharmacy technician or pharmacy technician trainee acting under the direct supervision of a pharmacist.
(6) A pharmacist or pharmacist intern may not refuse to transfer original prescription information to another pharmacist or pharmacist intern who is acting on behalf of a patient and who is making a request for this information as specified in paragraphs (4) and (5) of this subsection.
(f) Limitation to one type of recordkeeping system. When filing prescription drug order information a pharmacy may use only one of the two systems described in subsection (d) or (e) of this section.
(g) Distribution of controlled substances to another registrant. A pharmacy may distribute controlled substances to a practitioner, another pharmacy, or other registrant, without being registered to distribute, under the following conditions.
(1) The registrant to whom the controlled substance is to be distributed is registered under the Controlled Substances Act to dispense that controlled substance.
(2) The total number of dosage units of controlled substances distributed by a pharmacy may not exceed 5.0% of all controlled substances dispensed and distributed by the pharmacy during the 12-month period in which the pharmacy is registered; if at any time it does exceed 5.0%, the pharmacy is required to obtain an additional registration to distribute controlled substances.
(3) If the distribution is for a Schedule III, IV, or V controlled substance, a record shall be maintained which indicates:
(A) the actual date of distribution;
(B) the name, strength, and quantity of controlled substances distributed;
(C) the name, address, and DEA registration number of the distributing pharmacy; and
(D) the name, address, and DEA registration number of the pharmacy, practitioner, or other registrant to whom the controlled substances are distributed.
(4) If the distribution is for a Schedule I or II controlled substance, the following is applicable.
(A) The pharmacy, practitioner, or other registrant who is receiving the controlled substances shall issue Copy 1 and Copy 2 of a DEA order form (DEA 222C) to the distributing pharmacy.
(B) The distributing pharmacy shall:
(i) complete the area on the DEA order form (DEA 222C) titled "To Be Filled in by Supplier";
(ii) maintain Copy 1 of the DEA order form (DEA 222C) at the pharmacy for two years; and
(iii) forward Copy 2 of the DEA order form (DEA 222C) to the Divisional Office of the Drug Enforcement Administration.
(h) Other records. Other records to be maintained by a pharmacy:
(1) a permanent log of the initials or identification codes which will identify each dispensing pharmacist by name (the initials or identification code shall be unique to ensure that each pharmacist can be identified, i.e., identical initials or identification codes shall not be used);
(2) Copy 3 of DEA order form (DEA 222C) which has been properly dated, initialed, and filed, and all copies of each unaccepted or defective order form and any attached statements or other documents;
(3) a hard copy of the power of attorney to sign DEA 222C order forms (if applicable);
(4) suppliers' invoices of dangerous drugs and controlled substances; a pharmacist shall verify that the controlled drugs listed on the invoices were actually received by clearly recording his/her initials and the actual date of receipt of the controlled substances;
(5) suppliers' credit memos for controlled substances and dangerous drugs;
(6) a hard copy of inventories required by §291.17 of this title (relating to Inventory Requirements);
(7) hard-copy reports of surrender or destruction of controlled substances and/or dangerous drugs to an appropriate state or federal agency;
(8) a hard copy of the Schedule V nonprescription register book;
(9) records of distribution of controlled substances and/or dangerous drugs to other pharmacies, practitioners, or registrants; and
(10) a hard copy of any notification required by the Texas Pharmacy Act or the sections in this chapter, including, but not limited to, the following:
(A) reports of theft or significant loss of controlled substances to DEA, Department of Public Safety, and the board;
(B) notifications of a change in pharmacist-in-charge of a pharmacy; and
(C) reports of a fire or other disaster which may affect the strength, purity, or labeling of drugs, medications, devices, or other materials used in the diagnosis or treatment of injury, illness, and disease.
(i) Permission to maintain central records. Any pharmacy that uses a centralized recordkeeping system for invoices and financial data shall comply with the following procedures.
(1) Controlled substance records. Invoices and financial data for controlled substances may be maintained at a central location provided the following conditions are met.
(A) Prior to the initiation of central recordkeeping, the pharmacy submits written notification by registered or certified mail to the divisional director of the Drug Enforcement Administration as required by Title 21, Code of Federal Regulations, §1304.04(a), and submits a copy of this written notification to the Texas State Board of Pharmacy. Unless the registrant is informed by the divisional director of the Drug Enforcement Administration that permission to keep central records is denied, the pharmacy may maintain central records commencing 14 days after receipt of notification by the divisional director.
(B) The pharmacy maintains a copy of the notification required in subparagraph (A) of this paragraph.
(C) The records to be maintained at the central record location shall not include executed DEA order forms, prescription drug orders, or controlled substance inventories, which shall be maintained at the pharmacy.
(2) Dangerous drug records. Invoices and financial data for dangerous drugs may be maintained at a central location.
(3) Access to records. If the records are kept on microfilm, computer media, or in any form requiring special equipment to render the records easily readable, the pharmacy shall provide access to such equipment with the records.
(4) Delivery of records. The pharmacy agrees to deliver all or any part of such records to the pharmacy location within two business days of written request of a board agent or any other authorized official.
(j) Ownership of pharmacy records. For the purposes of these sections, a pharmacy licensed under the Act is the only entity which may legally own and maintain prescription drug records.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on August 18, 2008.
TRD-200804416
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: September 7, 2008
Proposal publication date: March 21, 2008
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy adopts amendments to §291.72, concerning Definitions, §291.73, concerning Personnel, and §291.74, concerning Operational Standards. The amendments are adopted without changes to the proposed text as published in the June 20, 2008, issue of the Texas Register (33 TexReg 4790).
The adopted amendments to §291.72 define physically present supervision and electronic supervision. The adopted amendments to §291.73 require the pharmacy to document the identity of each pharmacist involved in a specific portion of the distribution process if the pharmacy's data processing system is capable of recording such information and outline the duties for pharmacy technicians and pharmacy technician trainees that must be performed under the physically present supervision of a pharmacist and duties that may be performed under the electronic supervision of a pharmacist. The adopted amendments to §291.74 remove the storage of drugs requirements and locate the requirements in new §291.15, adopted elsewhere in this issue of the Texas Register, and replace the term substitute with the term interchange.
No comments were received regarding adoption of the amendments.
The amendments are adopted under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on August 18, 2008.
TRD-200804417
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: September 7, 2008
Proposal publication date: June 20, 2008
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy adopts amendments to §291.91, concerning Definitions, §291.92, concerning Personnel, §291.93, concerning Operational Standards, and §291.94, concerning Records. The amendments are adopted without changes to the proposed text as published in the June 20, 2008, issue of the Texas Register (33 TexReg 4793).
The amendments incorporate the recommendations of the Task Force on Clinic Pharmacies (Class D). Specifically, the amendments, update the definition of "practitioner" to be consistent with the Texas Pharmacy Act; update formulary requirements to allow Class D pharmacies with expanded formularies to have antipsychotic drugs; prohibit Class D pharmacies from having Carisoprodal or drugs used to treat erectile dysfunction; allow Class D pharmacies with expanded formularies including drugs requiring special monitoring to submit policies and procedures regarding the provision of such drugs; clarify that Class D pharmacies wishing to add drugs to an expanded formulary must make such a request in writing to the Board prior to adding the drugs; require pharmacists to conduct retrospective drug reviews on a quarterly basis in Class D pharmacies with expanded formularies; require an initial order by a physician for antipsychotic drugs provided in a Class D pharmacy, followed by monitored therapy and at least yearly physical exams by the physician; and require a licensed nurse or practitioner to provide verbal and written information to the patient.
No comments were received regarding adoption of the amendments.
The amendments are adopted under §551.002, and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by this rule: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on August 18, 2008.
TRD-200804418
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: September 7, 2008
Proposal publication date: June 20, 2008
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy adopts amendments to §291.133, concerning Pharmacies Compounding Sterile Preparations. The amendments are adopted without changes to the proposed text as published in the June 20, 2008, issue of the Texas Register (33 TexReg 4799).
The amendments remove the storage of drugs requirements and locate the requirements in new §291.15 adopted elsewhere in this issue of the Texas Register.
No comments were received regarding adoption of the amendments.
The amendments are adopted under §551.002, and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by this rule: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on August 18, 2008.
TRD-200804419
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: September 7, 2008
Proposal publication date: June 20, 2008
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy adopts amendments to §305.2, concerning Pharmacy Technician Training Programs. The amendments are adopted without changes to the proposed text as published in the June 20, 2008, issue of the Texas Register (33 TexReg 4800).
The amendments clarify that individuals enrolled in pharmacy technician training programs must be registered with the Board prior to working in a pharmacy as part of the experiential component of the training program.
No comments were received regarding adoption of the amendments.
The amendments are adopted under §§551.002, 554.002, and 554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.002 as authorizing the agency to adopt rules regarding the training, qualifications, and employment of pharmacy technicians. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by this rule: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on August 18, 2008.
TRD-200804420
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: September 7, 2008
Proposal publication date: June 20, 2008
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy adopts amendments to §309.3, concerning Generic Substitution with changes to the proposed text as published in the June 20, 2008, issue of the Texas Register (33 TexReg 4800).
Elsewhere in this issue of the Texas Register, the Texas State Board of Pharmacy contemporaneously withdraws the proposed amendments to §309.1, concerning Objective.
The amendments to §309.3 are adopted with changes based on comments received as described below.
Comments were received as follows:
The Epilepsy Foundation, Southeast Texas, commented that the proposed rules do not provide additional protection for patients with epilepsy and are not any different from what is in current law. The Board disagrees with this comment. A physician may now prohibit substitution by following the dispensing directive and if a physician allows substitution the pharmacy must dispense a product that the federal Food and Drug Administration has determined to be equivalent to the brand name product.
The Generic Pharmaceutical Association commented that the proposed amendments: create an inference that one generic is better than another, with no data to back up such an implication; require pharmacies to increase inventories leading to increased costs of doing business; could increase marketing costs by encouraging generic drug manufacturers to launch marketing campaigns to promote their products; would result in higher costs to the State of Texas; and shelter the practitioner from having to explicitly set forth a clinical determination of the medical necessity for substitution prohibition. The Board disagrees with this comment; however, the Board has amended the proposed rules to delete the requirement regarding practitioners issuing prescriptions for a generic product with a particular manufacturer specified.
American Pharmacies commented in support of the rules regarding prescriptions issued for the brand name products when no generic product is available. However, American Pharmacies opposed the proposed rules regarding practitioners specifying a particular manufacturer. The Board disagrees with this comment; however, the Board had amended the proposed rules to delete the requirement regarding practitioners issuing prescriptions for a generic product with a particular manufacturer specified at this time.
UCB commented in support of the proposed language. The Board agrees with this comment; however, the Board is not adopting these requirements regarding practitioners issuing prescriptions for a generic product with a particular manufacturer specified at this time.
Texas Pharmacy Association requested that the Board further study the issue and postpone adoption of the proposed rules. The Board disagrees with the comments and believes the issue has been reviewed adequately.
Medco Health Solutions commented that the proposed rules could undermine the established FDA generic substitution guidelines and asked the Board to reconsider the amendments to ensure the amendments are in the interest of the public. The Board disagrees with this comment and believes that the rules as adopted are in the interest of the public.
The amendments are adopted under §§551.002, 554.051, and 562.0141 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §562.0141 as authorizing the agency, in consultation with the Texas Medical Board, to establish by rule a list of NTI drugs.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§309.3.Generic Substitution.
(a) General requirements. In accordance with Chapter 562 of the Act, a pharmacist may dispense a generically equivalent drug product if:
(1) the generic product costs the patient less than the prescribed drug product;
(2) the patient does not refuse the substitution; and
(3) the practitioner does not certify on the prescription form that a specific prescribed brand is medically necessary as specified in a dispensing directive described in subsection (c) of this section.
(b) Prescription format for written prescription drug orders.
(1) A written prescription drug order issued in Texas may:
(A) be on a form containing a single signature line for the practitioner; and
(B) contain the following reminder statement on the face of the prescription: "A generically equivalent drug product may be dispensed unless the practitioner hand writes the words 'Brand Necessary' or 'Brand Medically Necessary' on the face of the prescription."
(2) A pharmacist may dispense a prescription that is not issued on the form specified in paragraph (1) of this subsection, however, the pharmacist may dispense a generically equivalent drug product unless the practitioner has prohibited substitution through a dispensing directive in compliance with subsection (c)(1) of this section.
(3) The prescription format specified in paragraph (1) of this subsection does not apply to the following types of prescription drug orders:
(A) prescription drug orders issued by a practitioner in a state other than Texas;
(B) prescriptions for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; or
(C) prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment.
(4) In the event of multiple prescription orders appearing on one prescription form, the practitioner shall clearly identify to which prescription(s) the dispensing directive(s) apply. If the practitioner does not clearly indicate to which prescription(s) the dispensing directive(s) apply, the pharmacist may substitute on all prescriptions on the form.
(c) Dispensing directive.
(1) General requirements. The following is applicable to the dispensing directive outlined in this subsection.
(A) When a prescription is issued for a brand name product that has no generic equivalent product, the pharmacist must dispense the brand name product. If a generic equivalent product becomes available, a pharmacist may substitute the generically equivalent product unless the practitioner has specified on the initial prescription that the brand name product is medically necessary.
(B) If the practitioner has prohibited substitution through a dispensing directive in compliance with this subsection, a pharmacist shall not substitute a generically equivalent drug product unless the pharmacist obtains verbal or written authorization from the practitioner, notes such authorization on the original prescription drug order, and notifies the patient in accordance with §309.4 of this title (relating to Patient Notification).
(2) Written prescriptions.
(A) A practitioner may prohibit the substitution of a generically equivalent drug product for a brand name drug product by writing across the face of the written prescription, in the practitioner's own handwriting, the phrase "brand necessary" or "brand medically necessary."
(B) The dispensing directive shall:
(i) be in a format that protects confidentiality as required by the Health Insurance Portability and Accountability Act of 1996 (29 U.S.C. Section 1181 et seq.) and its subsequent amendments; and
(ii) comply with federal and state law, including rules, with regard to formatting and security requirements.
(C) The dispensing directive specified in this paragraph may not be preprinted, rubber stamped, or otherwise reproduced on the prescription form.
(D) A practitioner may prohibit substitution on a written prescription only by following the dispensing directive specified in this paragraph. Two-line prescription forms, check boxes, or other notations on an original prescription drug order which indicate "substitution instructions" are not valid methods to prohibit substitution, and a pharmacist may substitute on these types of written prescriptions.
(3) Verbal Prescriptions.
(A) If a prescription drug order is transmitted to a pharmacist orally, the practitioner or practitioner's agent shall prohibit substitution by specifying "brand necessary" or "brand medically necessary." The pharmacists shall note any substitution instructions by the practitioner or practitioner's agent, on the file copy of the prescription drug order. Such file copy may follow the one-line format indicated in subsection (b)(1) of this section, or any other format that clearly indicates the substitution instructions.
(B) If the practitioner's or practitioner's agent does not clearly indicate that the brand name is medically necessary, the pharmacist may substitute a generically equivalent drug product.
(C) To prohibit substitution on a verbal prescription reimbursed through the medical assistance program specified in 42 C.F.R., §447.331:
(i) the practitioner or the practitioner's agent shall verbally indicate that the brand is medically necessary; and
(ii) the practitioner shall mail or fax a written prescription to the pharmacy which complies with the dispensing directive for written prescriptions specified in paragraph (1) of this subsection within 30 days.
(4) Electronic prescription drug orders.
(A) To prohibit substitution, the practitioner or practitioner's agent shall note "brand necessary" or "brand medically necessary" in the electronic prescription drug order.
(B) If the practitioner or practitioner's agent does not clearly indicate in the electronic prescription drug order that the brand is medically necessary, the pharmacist may substitute a generically equivalent drug product.
(C) To prohibit substitution on an electronic prescription drug order reimbursed through the medical assistance program specified in 42 C.F.R., §447.331, the practitioner shall fax a copy of the original prescription drug order which complies with the requirements of a written prescription drug order specified in paragraph (1) of this subsection within 30 days.
(5) Prescriptions issued by out-of-state, Mexican, Canadian, or federal facility practitioners.
(A) The dispensing directive specified in this subsection does not apply to the following types of prescription drug orders:
(i) prescription drug orders issued by a practitioner in a state other than Texas;
(ii) prescriptions for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; or
(iii) prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment.
(B) A pharmacist may not substitute on prescription drug orders identified in subparagraph (A) of this paragraph unless the practitioner has authorized substitution on the prescription drug order. If the practitioner has not authorized substitution on the written prescription drug order, a pharmacist shall not substitute a generically equivalent drug product unless:
(i) the pharmacist obtains verbal or written authorization from the practitioner (such authorization shall be noted on the original prescription drug order); or
(ii) the pharmacist obtains written documentation regarding substitution requirements from the State Board of Pharmacy in the state, other than Texas, in which the prescription drug order was issued. The following is applicable concerning this documentation.
(I) The documentation shall state that a pharmacist may substitute on a prescription drug order issued in such other state unless the practitioner prohibits substitution on the original prescription drug order.
(II) The pharmacist shall note on the original prescription drug order the fact that documentation from such other state board of pharmacy is on file.
(III) Such documentation shall be updated yearly.
(d) Substitution of dosage form.
(1) As specified in §562.012 of the Act, a pharmacist may dispense a dosage form of a drug product different from that prescribed, such as tablets instead of capsules or liquid instead of tablets, provided:
(A) the patient consents to the dosage form substitution;
(B) the pharmacist notifies the practitioner of the dosage form substitution; and
(C) the dosage form so dispensed:
(i) contains the identical amount of the active ingredients as the dosage prescribed for the patient;
(ii) is not an enteric-coated or time release product; and
(iii) does not alter desired clinical outcomes;
(2) Substitution of dosage form may not include the substitution of a product that has been compounded by the pharmacist unless the pharmacist contacts the practitioner prior to dispensing and obtains permission to dispense the compounded product.
(e) Refills.
(1) Original substitution instructions. All refills shall follow the original substitution instructions unless otherwise indicated by the practitioner or practitioner's agent.
(2) Narrow therapeutic index drugs.
(A) The board and the Texas Medical Board shall establish a joint committee to recommend to the board a list of narrow therapeutic index drugs and the rules, if any, by which this paragraph applies to those drugs. The committee must consist of an equal number of members from each board. The committee members shall select a member of the committee to serve as presiding officer for a one year term. The presiding officer may not represent the same board as the presiding officer's predecessor.
(B) The board, on the recommendation of the joint committee, has determined that no drugs shall be included on a list of narrow therapeutic index drugs as defined in §562.014, Occupations Code.
(i) The board has specified in §309.7 of this title (relating to dispensing responsibilities) that for drugs listed in the publication, pharmacist shall use as a basis for determining generic equivalency, Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication. For drugs listed in the publications, pharmacists may only substitute products that are rated therapeutically equivalent in the Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements.
(ii) Practitioners may prohibit substitution through a dispensing directive in compliance with subsection (c) of this section.
(C) The board shall reconsider the contents of the list if:
(i) the Federal Food and Drug Administration determines a new equivalence classification which indicates that certain drug products are equivalent but special notification to the patient and practitioner is required when substituting these products; or
(ii) any interested person petitions the board to reconsider the list. If the board receives a petition to include a drug on the list, the joint committee specified in subparagraph (A) of this paragraph shall review the request and make a recommendation to the board.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on August 18, 2008.
TRD-200804421
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: September 7, 2008
Proposal publication date: June 20, 2008
For further information, please call: (512) 305-8028