The Texas State Board of Pharmacy adopts a repeal of §§309.1 - 309.8, concerning Generic Substitution and simultaneously adopts new §§309.1 - 309.8, concerning Generic Substitution. The new §§309.2 - 309.4 and §309.6 are adopted with changes to the proposed text as published in the December 28, 2001, issue of the Texas Register (26 TexReg 10760). The repeal of §§309.1 - 309.8 and new §309.1 and §§309.5, 309.7, and 309.8 are adopted without changes to the proposed text as published and will not be republished.

The new rules: (1) implement the provisions of the Occupations Code §562.015, as added by Senate Bill 768, Texas Legislature, 77th Session, by establishing a "dispensing directive" for the communication of substitution instructions from practitioners to pharmacists; and (2) update citations to the new codified Texas Pharmacy Act as a result of the rule review process.

Written comments were received from the Texas Pharmacy Association, Albertson's, Eckerd Drugs, Brookshire Brothers Pharmacies, the National Association of Chain Drug Stores, the Texas Federation of Drug Stores, HEB Pharmacies, the Pharmaceutical Research and Manufacturers of America, the Texas Optometry Board, the Texas Medical Association, the Texas Nurses Association, the Texas Academy of Physician Assistants, the Texas Pediatric Society, the Texas Academy of Internal Medicine Services, the Texas Association of Family Physicians, the Coalition of Nurses in Advanced Practice, the Texas Podiatric Medical Association, the Texas Osteopathic Medical Association, and an individual physician.

General Comments: One comment opposed the requirement to place the brand name wording on all prescriptions when the federal requirement was only for medicaid prescriptions. The Board disagrees and believes the changes to the statute require the wording on all written prescriptions when substitution is not allowed. Other provision have been made for verbal, electronic, and facsimile prescriptions when the prescription is not for a medicaid patient. Several comments suggested a vigorous educational program for all prescribers and pharmacists. The Board agrees and will work with the appropriate agencies and associations in an educational program.

Specific Comments:

Section 309.2--Two comments were received indicating that the definition of electronic prescription drug order should not include facsimile because it conflict with other sections of the amendment. The Board agrees and amended the definition and included a definition of facsimile. Another commentor indicated that the definition of practitioner needs to include a therapeutic optometrist. The Board agrees and amended the definition appropriately.

Section 309.3(b)--Several comments indicated that the statement contained on the prescription should not be mandatory and should indicate that a pharmacist may, rather than will, substitute. The Board agrees and made appropriate changes. Two comments indicated that paragraph (2) should add a reference to subsection (a)(1). The Board disagrees and believes the general requirements of subsection (a)(1) are implicit. Several commentors suggested language to require a practitioner to clearly indicate to which prescriptions a dispensing directive refers when a prescription contains more than one prescription on the form. The Board concurs with this comment and made appropriate changes.

Section 309.3(c)(1)--Two comments were received with language to clarify the proposed language of subparagraph (A). The Board concurs with the comments and made the suggested changes. One comment suggested a new subparagraph stating that a facsimile prescription should be considered a written prescription drug order. The Board disagrees. The suggested language does not add to the clarity of the rules and conflict with other sections of the Board's rules. Two comments suggested a change to subparagraph (D) to clarify that a pharmacist may only substitute when the general requirements of subsection (a) are met. The Board disagrees as the provisions of (a) are already requirements for all substitutions

Section 309.3(c)(3)--Two comments wanted to delete the requirement for the specific wording "brand necessary" or "brand medically necessary" in subparagraphs (A) and (B) on electronic prescription drug orders. One commentor believes that the statute specifically requires an exemption from the use of one of the terms to prohibit substitution, and this rule do not allow for such an exemption. The Board disagrees and believes the rule as drafted does provide an exemption from the requirement since the prescriber is not required to write one of the statements in their own handwriting as with a written prescription. Two commentors suggested clarifying that the physician had only 30 days to follow-up with a prescription in subparagraph (C). The Board agrees and appropriate changes were made.

Section 309.3(c)(4)--Several comments were received indicating that this paragraph is an inappropriate delegation of power to a federal agency. The Board agrees and deleted the requirement.

Section 309.4--One comment was received suggesting a change to clarify that only one generic substitution sign posted in a pharmacy is required to be in compliance with the requirements. The Board agrees and made appropriate changes.