1. (a) Maintenance of records.

   1. (1) Every inventory or other record required to be kept under this section shall be 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 other authorized local, state, or federal law enforcement agencies.
   2. (2) Records of controlled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy.
   3. (3) Records of controlled substances, other than original 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. (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:

      1. (A) the records maintained in the alternative system contain all of the information required on the manual record; and
      2. (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.

2. (b) Prescriptions.

   1. (1) Professional responsibility. Pharmacists shall exercise sound professional judgment with respect to the accuracy and authenticity of any radioactive prescription drug order they dispense. If the pharmacist questions the accuracy or authenticity of a radioactive prescription drug order, he/she shall verify the order with the practitioner prior to dispensing.

   2. (2) Verbal radioactive prescription drug orders.

      1. (A) Only an authorized nuclear pharmacist or a pharmacist-intern under the direct supervision of an authorized nuclear pharmacist may receive from a practitioner or a practitioner's designated agent:

         1. (i) a verbal therapeutic prescription drug order; or
         2. (ii) a verbal diagnostic prescription drug order in instances where patient specificity is required for patient safety (e.g., radiolabeled blood products, radiolabeled antibodies).
      2. (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.
      3. (C) If a radioactive prescription drug order is transmitted to an authorized nuclear pharmacist verbally, the pharmacist 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 two-line format indicated in paragraph (3)(B) of this subsection, or any other format that clearly indicates the substitution instructions.
      4. (D) A pharmacist may not dispense a verbal radioactive prescription drug order for a Schedule III, IV, or V controlled substance issued by a practitioner licensed in another state unless the practitioner is also registered under the Texas Controlled Substances Act.
      5. (E) A pharmacist may not dispense a verbal radioactive 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.

   3. (3) Written radioactive prescription drug orders.

      1. (A) Practitioner's signature. Written radioactive prescription drug orders shall be manually signed by the practitioner (electronically produced or rubber stamped signatures may not be used).

         1. (i) A practitioner may sign a radioactive 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.
         2. (ii) The radioactive 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 radioactive prescription drug order does not conform in all essential respects to the law and regulations.

      2. (B) Required radioactive prescription drug order format.

         1. (i) A pharmacist may not dispense a written radioactive prescription drug order issued in Texas unless it is ordered on a form containing two signature lines of equal prominence, side by side, at the bottom of the form. Under either signature line shall be printed clearly the words "product selection permitted," and under the other signature line shall be printed clearly the words "dispense as written."

         2. (ii) The two signature line requirement does not apply to the following types of radioactive prescriptions drug orders:

            1. (I) radioactive prescription drug orders issued by a practitioner in a state other than Texas;
            2. (II) radioactive prescription drug orders for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; and
            3. (III) radioactive prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment.
      3. (C) Preprinted radioactive prescription drug order forms. No radioactive prescription drug order form furnished to a practitioner shall contain a preprinted order for a radiopharmaceutical by brand name, generic name, or manufacturer.

      4. (D) Radioactive prescription drug orders written by practitioners in another state.

         1. (i) Dangerous drug prescription orders. A pharmacist may dispense a radioactive prescription drug order for dangerous drugs issued by practitioners in a state other than Texas in the same manner as radioactive prescription drug orders for dangerous drugs issued by practitioners in Texas are dispensed.

         2. (ii) Controlled substance prescription drug orders. A pharmacist may dispense radioactive prescription drug orders for controlled substances in Schedule III, IV, or V issued by a practitioner in another state provided:

            1. (I) the radioactive 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 registration number, and who may legally prescribe Schedule III, IV, or V controlled substances in such other state;
            2. (II) the radioactive 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
            3. (III) if there are no refill instructions on the original written radioactive prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original written radioactive prescription drug order have been dispensed, a new written radioactive prescription drug order is obtained from the prescribing practitioner prior to dispensing any additional quantities of controlled substances.

      5. (E) Radioactive prescription drug orders written by practitioners in the United Mexican States or the Dominion of Canada.

         1. (i) Controlled substance prescription drug orders. A pharmacist may not dispense a radioactive prescription drug order for a Schedule II, III, IV, or V controlled substance issued by a practitioner licensed in the Dominion of Canada or the United Mexican States.

         2. (ii) Dangerous drug prescription drug orders. A pharmacist may dispense a radioactive prescription drug order for a dangerous drug issued by a person licensed in the Dominion of Canada or the United Mexican States as a physician, dentist, veterinarian, or podiatrist provided:

            1. (I) the radioactive prescription drug order is an original written prescription; and
            2. (II) if there are no refill instructions on the original written radioactive prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original written radioactive prescription drug order have been dispensed, a new written radioactive prescription drug order shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of dangerous drugs.
         3. (iii) 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 a triplicate prescription form as required by the Texas Controlled Substances Act, §481.075.

   4. (4) Electronic radioactive prescription drug orders. For the purpose of this paragraph, electronic radioactive prescription drug orders shall be considered the same as verbal radioactive prescription drug orders.

      1. (A) An electronic radioactive prescription drug order may be transmitted by a practitioner or a practitioner's designated agent:

         1. (i) directly to a pharmacy; or

         2. (ii) through the use of a data communication device provided:

            1. (I) the prescription information is not altered during transmission; and
            2. (II) confidential patient information is not accessed or maintained by the operator of the data communication device unless the operator is authorized to receive the confidential information as specified in subsection (f) of this section.
      2. (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.

      3. (C) A pharmacist may not dispense an electronic radioactive prescription drug order for a:

         1. (i) Schedule II controlled substance;
         2. (ii) Schedule III, IV, or V controlled substance issued by a practitioner licensed in another state unless the practitioner is also registered under the Texas Controlled Substances Act; or
         3. (iii) 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.
      4. (D) The practitioner or practitioner's agent shall note any substitution instructions on the electronic radioactive prescription drug order. Such electronic radioactive prescription drug order may follow the two-line format indicated in paragraph (3)(B) of this subsection or any other format that clearly indicated the substitution instructions.

   5. (5) Authorization for generic substitution.

      1. (A) A pharmacist may dispense a generically equivalent drug product if:

         1. (i) the generic product cost the patient less than the prescribed drug product;
         2. (ii) the patient does not refuse the substitution; and
         3. (iii) the prescribing practitioner authorizes the substitution of a generically equivalent product; or
         4. (iv) the practitioner or practitioner's agent does not clearly indicate that the verbal or electronic prescription drug order shall be dispensed as ordered.
      2. (B) Practitioners shall indicate their dispensing instructions by signing on either the "Dispense as Written" or "Product Selection Permitted" line on the radioactive prescription drug order. If the practitioner's signature does not clearly indicate the radioactive prescription drug order shall be dispensed as written, the pharmacist may substitute a generically equivalent drug product.
      3. (C) A pharmacist may not substitute on radioactive prescription drug orders identified in paragraph (3)(D) and (E) of this subsection unless the practitioner has authorized substitution on the radioactive prescription drug order.

      4. (D) If the practitioner has not authorized substitution on the written radioactive prescription drug order, a pharmacist shall not substitute a generically equivalent drug product unless:

         1. (i) the pharmacist obtains verbal or written authorization from the practitioner (such authorization shall be noted on the original radioactive prescription drug order); or

         2. (ii) the pharmacist obtains written documentation regarding substitution requirements from the State Board of Pharmacy in the state, other than Texas, in which the radioactive prescription drug order was issued. The following is applicable concerning this documentation.

            1. (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.
            2. (II) The pharmacist shall note on the original radioactive prescription drug order the fact that documentation from such other state board of pharmacy is on file.
            3. (III) Such documentation shall be updated yearly.

   6. (6) Original prescription drug order records.

      1. (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.
      2. (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.

      3. (C) Original prescriptions shall be maintained in one of the following formats:

         1. (i) in three separate files as follows:

            1. (I) prescriptions for controlled substances listed in Schedule II;
            2. (II) prescriptions for controlled substances listed in Schedule III-V; and
            3. (III) prescriptions for dangerous drugs and nonprescription drugs; or
         2. (ii) within a patient medication record system provided that original prescriptions for controlled substances are maintained separate from original prescriptions for noncontrolled substances and triplicate prescriptions for Schedule II controlled substances are maintained separate from all other original prescriptions.

      4. (D) Original prescription records other than triplicate prescriptions 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.

         1. (i) The record of refills recorded on the original prescription must also be stored in this system.
         2. (ii) The original prescription records must be maintained in numerical order and as specified in subparagraph (C) of this paragraph.
         3. (iii) The pharmacy must provide immediate access to equipment necessary to render the records easily readable.

   7. (7) Prescription drug order information.

      1. (A) All original radioactive prescription drug orders shall bear:

         1. (i) name of the patient, if applicable at the time of the order;
         2. (ii) name of the institution;
         3. (iii) name, and if for a controlled substance, the address and DEA registration number of the practitioner
         4. (iv) name of the radiopharmaceutical;
         5. (v) amount of radioactive material contained in millicuries (mCi), microcuries (uCi), or bequerels (Bq) and the corresponding time that applies to this activity, if different than the requested calibration date and time;
         6. (vi) date and time of calibration;
         7. (vii) if a liquid, the volume in milliliters;
         8. (viii) date of issuance; and
         9. (ix) if telephoned to the pharmacy by a designated agent, the full name of the designated agent.

      2. (B) All original electronic radioactive prescription drug orders shall bear:

         1. (i) name of the patient, if applicable at the time of the order;
         2. (ii) name of the institution;
         3. (iii) name, and if for a controlled substance, the address and DEA registration number of the practitioner;
         4. (iv) name of the radiopharmaceutical;
         5. (v) amount of radioactive material contained in millicuries (mCi), microcuries (uCi), or bequerels (Bq) and the corresponding time that applies to this activity, if different than the requested calibration date and time;
         6. (vi) date and time of calibration;
         7. (vii) if a liquid, the volume in milliliters;
         8. (viii) a statement which indicates that the prescription has been electronically transmitted (e.g., Faxed to or electronically transmitted to:);
         9. (ix) name, address, and electronic access number of the pharmacy to which the prescription was transmitted;
         10. (x) telephone number of the prescribing practitioner;
         11. (xi) date the prescription drug order was electronically transmitted to the pharmacy, if different from the date of issuance of the prescription;
         12. (xii) date of issuance; and
         13. (xiii) if telephoned to the pharmacy by a designated agent, the full name of the designated agent.

      3. (C) At the time of dispensing, a pharmacist is responsible for the addition of the following information to the original prescription:

         1. (i) unique identification number of the prescription drug order;
         2. (ii) initials or identification code of the person who compounded the sterile radiopharmaceutical and the pharmacist who checked and released the product;
         3. (iii) name, quantity, lot number, and expiration date of each product used in compounding the sterile radiopharmaceutical; and
         4. (iv) date of dispensing, if different from the date of issuance.
   8. (8) Refills. A radioactive prescription drug order must be filled from an original prescription which may not be refilled.

3. (c) Policy and procedure manual.

   1. (1) All nuclear pharmacies shall maintain a policy and procedure manual. The nuclear pharmacy policy and procedure manual is a compilation of written policy and procedure statements.
   2. (2) A technical operations manual governing all nuclear pharmacy functions shall be prepared. It shall be continually revised to reflect changes in techniques, organizations, etc. All pharmacy personnel shall be familiar with the contents of the manual.
   3. (3) The nuclear pharmacy policies and procedures manual shall be prepared by the pharmacist-in-charge with input from the affected personnel and from other involved staff and committees to govern procurement, preparation, distribution, storage, disposal, and control of all drugs used and the need for policies and procedures relative to procurement of multisource items, inventory, investigational drugs, and new drug applications.

4. (d) Other records. Other records to be maintained by a pharmacy:

   1. (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. (2) copy 3 of DEA order form (DEA 222) 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. (3) a hard copy of the power of attorney to sign DEA 222 order forms (if applicable);
   4. (4) suppliers' invoices of dangerous drugs and controlled substances; pharmacists or other responsible individuals shall verify that the controlled drugs listed on the invoices were actually received by clearly recording their initials and the actual date of receipt of the controlled substances;
   5. (5) suppliers' credit memos for controlled substances and dangerous drugs;
   6. (6) a hard copy of inventories required by §291.17 of this title (relating to Inventory Requirements);
   7. (7) hard-copy reports of surrender or destruction of controlled substances and/or dangerous drugs to an appropriate state or federal agency;
   8. (8) records of distribution of controlled substances and/or dangerous drugs to other pharmacies, practitioners, or registrants; and

   9. (9) a hard copy of any notification required by the Texas Pharmacy Act or these sections, including, but not limited to, the following:

      1. (A) reports of theft or significant loss of controlled substances to DEA, DPS, and the board;
      2. (B) notifications of a change in pharmacist-in-charge of a pharmacy; and
      3. (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.

5. (e) 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. (1) Controlled substance records. Invoices and financial data for controlled substances may be maintained at a central location provided the following conditions are met.

      1. (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 the Code of Federal Regulations, Title 21, §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.
      2. (B) The pharmacy maintains a copy of the notification required in subparagraph (A) of this paragraph.
      3. (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. (2) Dangerous drug records. Invoices and financial data for dangerous drugs may be maintained at a central location.
   3. (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. (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.
   5. (5) Ownership of pharmacy records. For purposes of these sections, a pharmacy licensed under the Act is the only entity which may legally own and maintain prescription drug records.

6. (f) Confidentiality.

   1. (1) A pharmacist shall provide adequate security of radioactive prescription drug order and patient medication records to prevent indiscriminate or unauthorized access to confidential health information. If radioactive prescription drug orders, requests for refill authorization, or other confidential health information are not transmitted directly between a pharmacy and a physician but are transmitted through a data communication device, confidential health information may not be accessed or maintained by the operator of the data communication device unless specifically authorized to obtain the confidential information by this subsection.

   2. (2) Confidential records are privileged and may be released only to:

      1. (A) the patient or the patient's agent;
      2. (B) practitioners and other pharmacists when, in the pharmacist's professional judgment, such release is necessary to protect the patient's health and well-being;
      3. (C) other persons, the board, or other state or federal agencies authorized by law to receive such information;
      4. (D) a law enforcement agency engaged in investigation of suspected violations of the Controlled Substances Act or the Dangerous Drug Act;
      5. (E) a person employed by any state agency which licenses a practitioner as defined in the Act if such person is engaged in the performance of the person's official duties; or
      6. (F) an insurance carrier or other third party payor authorized by a patient to receive such information.

Source Note:The provisions of this §291.55 adopted to be effective March 19, 1998, 23 TexReg 2815.