| (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.
|
| Source Note: The provisions of this §291.55 adopted to be effective March 19, 1998, 23 TexReg 2815; amended to be effective June 1, 2002, 27 TexReg 1781; amended to be effective June 6, 2004, 29 TexReg 5362; amended to be effective December 3, 2006, 31 TexReg 9610; amended to be effective September 14, 2010, 35 TexReg 8357; amended to be effective June 20, 2019, 44 TexReg 2947; amended to be effective December 10, 2020, 45 TexReg 8855 |
