22 Tex. Admin. Code § 291.55 - Records
(a) Maintenance of records.
(1) Every inventory or other record required
to be kept under this section 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 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 board. If
the pharmacy maintains the records in an electronic format, the requested
records must be provided in a mutually agreeable electronic format it
specifically requested by the board or its representative. 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.
(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 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) 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 request of the board, its
representative, or other authorized local, state, or federal law enforcement or
regulatory agencies.
(b) Prescriptions.
(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) Oral radioactive
prescription drug orders.
(A) Only a
pharmacist may receive an oral prescription drug order for a controlled
substance. Only an authorized nuclear pharmacist, or a pharmacist-intern or
pharmacy technician under the direct supervision of an authorized nuclear
pharmacist, may receive from a practitioner or a practitioner's designated
agent:
(i) an oral therapeutic prescription
drug order; or
(ii) an oral
diagnostic prescription drug order in instances where patient specificity is
required for patient safety (e.g., radiolabeled blood products, radiolabeled
antibodies).
(B) A
practitioner shall designate in writing the name of each agent authorized by
the practitioner to communicate prescriptions orally 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 oral 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) Radioactive prescription drug orders
issued by practitioners in another state.
(A)
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.
(B) 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:
(i) the radioactive
prescription drug order is 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 Drug Enforcement
Administration registration number, and who may legally prescribe Schedule III,
IV, or V controlled substances in such other state; and
(ii) the radioactive prescription drug order
is not dispensed more than six months from the initial date of
issuance.
(4)
Radioactive prescription drug orders issued by practitioners in the United
Mexican States or the Dominion of Canada.
(A)
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.
(B)
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 the radioactive prescription drug
order is an original written prescription.
(C) 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.
(5)
Electronic radioactive prescription drug orders. For the purpose of this
paragraph, electronic radioactive prescription drug orders shall be considered
the same as oral radioactive prescription drug orders.
(A) An electronic radioactive 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 radioactive prescription drug order
for a:
(i) Schedule II controlled substance
except as authorized in §481.075, 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.
(6) Original
prescription drug order records.
(A) Original
prescriptions shall be maintained and readily retrievable by the pharmacy and
remain accessible for a period of two years from the date of filling.
(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 one of the following formats:
(i) 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; or
(ii) within a patient medication record
system provided that original prescriptions for controlled substances are
maintained separate from original prescriptions for noncontrolled substances
and prescriptions for Schedule II controlled substances are maintained separate
from all other original prescriptions.
(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., a digitalized imaging system. If original
prescription records are stored in a direct imaging system, the following is
applicable:
(i) The original prescription
records must be maintained and readily retrievable as specified in subparagraph
(C) of this paragraph.
(ii) The
pharmacy must provide immediate access to equipment necessary to render the
records easily readable.
(7) Prescription drug order information.
(A) All original radioactive prescription
drug orders shall bear:
(i) the name of the
patient, if applicable at the time of the order;
(ii) the name of the institution;
(iii) the name, and if for a controlled
substance, the address and DEA registration number of the
practitioner;
(iv) the name of the
radiopharmaceutical;
(v) the 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;
(vi) the date and time of calibration;
and
(vii) the date of
issuance.
(B) At the time
of dispensing, a pharmacist is responsible for the addition of the following
information to the original prescription:
(i)
the unique identification number of the prescription drug order;
(ii) the initials or identification code of
the person who compounded the sterile radiopharmaceutical and the pharmacist
who checked and released the product unless maintained in a readily retrievable
format;
(iii) the name, quantity,
lot number, and expiration date of each product used in compounding the sterile
radiopharmaceutical; and
(iv) the
date of dispensing, if different from the date of issuance.
(8) Refills. A
radioactive prescription drug order must be filled from an original
prescription which may not be refilled.
(c) Policy and procedure manual.
(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) 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) 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.
(d) Other
records. Other records to be maintained by a pharmacy:
(1) a permanent log of the initials or
identification codes which identifies each dispensing pharmacist by name (the
initials or identification codes 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
forms (DEA 222) which have 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 222 order forms (if applicable);
(4) suppliers' invoices of 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) records of distribution of controlled
substances and/or dangerous drugs to other pharmacies, practitioners, or
registrants; and
(9) a hard copy of
any notification required by the Texas Pharmacy Act or these sections,
including, but not limited to, the following:
(A) reports of theft or significant loss of
controlled substances to DEA 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.
(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) 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 DEA as required by the Code of
Federal Regulations, Title 21, §1304.04(a), and submits a copy of this
written notification to the board. Unless the registrant is informed by the
divisional director of DEA 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 an authorized agent of the board or any
other authorized official.
(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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
(a) Maintenance of records.
(1) Every inventory or other record required to be kept under this section 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 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 board . If the pharmacy maintains the records in an electronic format, the requested records must be provided in a mutually agreeable electronic format it specifically requested by the board or its representative. 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 .
(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 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) 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 request of the board , its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.
(b) Prescriptions.
(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) Oral radioactive prescription drug orders.
(A) Only a pharmacist may receive an oral prescription drug order for a controlled substance . Only an authorized nuclear pharmacist , or a pharmacist -intern or pharmacy technician under the direct supervision of an authorized nuclear pharmacist , may receive from a practitioner or a practitioner 's designated agent :
(i) an oral therapeutic prescription drug order ; or
(ii) an oral diagnostic prescription drug order in instances where patient specificity is required for patient safety (e.g., radiolabeled blood products, radiolabeled antibodies).
(B) A practitioner shall designate in writing the name of each agent authorized by the practitioner to communicate prescriptions orally 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 oral 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) Radioactive prescription drug orders issued by practitioners in another state.
(A) 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.
(B) 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:
(i) the radioactive prescription drug order is 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 Drug Enforcement Administration registration number, and who may legally prescribe Schedule III, IV, or V controlled substances in such other state; and
(ii) the radioactive prescription drug order is not dispensed more than six months from the initial date of issuance.
(4) Radioactive prescription drug orders issued by practitioners in the United Mexican States or the Dominion of Canada.
(A) 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.
(B) 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 the radioactive prescription drug order is an original written prescription.
(C) 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.
(5) Electronic radioactive prescription drug orders. For the purpose of this paragraph, electronic radioactive prescription drug orders shall be considered the same as oral radioactive prescription drug orders.
(A) An electronic radioactive 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 radioactive 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.
(6) Original prescription drug order records.
(A) Original prescriptions shall be maintained and readily retrievable by the pharmacy and remain accessible for a period of two years from the date of filling.
(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 one of the following formats:
(i) 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; or
(ii) within a patient medication record system provided that original prescriptions for controlled substances are maintained separate from original prescriptions for noncontrolled substances and prescriptions for Schedule II controlled substances are maintained separate from all other original prescriptions.
(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., a digitalized imaging system. If original prescription records are stored in a direct imaging system, the following is applicable:
(i) The original prescription records must be maintained and readily retrievable as specified in subparagraph (C) of this paragraph.
(ii) The pharmacy must provide immediate access to equipment necessary to render the records easily readable.
(7) Prescription drug order information.
(A) All original radioactive prescription drug orders shall bear:
(i) the name of the patient, if applicable at the time of the order;
(ii) the name of the institution;
(iii) the name, and if for a controlled substance , the address and DEA registration number of the practitioner ;
(iv) the name of the radiopharmaceutical ;
(v) the 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;
(vi) the date and time of calibration; and
(vii) the date of issuance.
(B) At the time of dispensing, a pharmacist is responsible for the addition of the following information to the original prescription :
(i) the unique identification number of the prescription drug order;
(ii) the initials or identification code of the person who compounded the sterile radiopharmaceutical and the pharmacist who checked and released the product unless maintained in a readily retrievable format;
(iii) the name, quantity, lot number, and expiration date of each product used in compounding the sterile radiopharmaceutical ; and
(iv) the date of dispensing, if different from the date of issuance.
(8) Refills. A radioactive prescription drug order must be filled from an original prescription which may not be refilled.
(c) Policy and procedure manual.
(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) 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) 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.
(d) Other records. Other records to be maintained by a pharmacy:
(1) a permanent log of the initials or identification codes which identifies each dispensing pharmacist by name (the initials or identification codes 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 forms (DEA 222) which have 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 222 order forms (if applicable);
(4) suppliers' invoices of 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) records of distribution of controlled substances and/or dangerous drugs to other pharmacies, practitioners, or registrants; and
(9) a hard copy of any notification required by the Texas Pharmacy Act or these sections, including, but not limited to, the following:
(A) reports of theft or significant loss of controlled substances to DEA 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.
(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) 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 DEA as required by the Code of Federal Regulations, Title 21, §1304.04(a), and submits a copy of this written notification to the board . Unless the registrant is informed by the divisional director of DEA 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 an authorized agent of the board or any other authorized official.
(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.