| (iii) An electronic transfer between pharmacies may
be initiated by a pharmacist intern, pharmacy technician, or pharmacy
technician trainee acting under the direct supervision of a pharmacist.
(9) An individual may not refuse to transfer original
prescription information to another individual who is acting on behalf
of a patient and who is making a request for this information as specified
in this subsection. The transfer of original prescription information
must be completed within four business hours of the request.
(10) When transferring a compounded prescription, a
pharmacy is required to provide all of the information regarding the
compounded preparation, including the formula, unless the formula
is patented or otherwise protected, in which case, the transferring
pharmacy shall, at a minimum, provide the quantity or strength of
all of the active ingredients of the compounded preparation.
(11) The electronic transfer of multiple or bulk prescription
records between two pharmacies is permitted provided:
(A) a record of the transfer as specified in paragraph
(5) of this subsection is maintained by the transferring pharmacy;
(B) the information specified in paragraph (6) of this
subsection is maintained by the receiving pharmacy; and
(C) in the event that the patient or patient's agent
is unaware of the transfer of the prescription drug order record,
the transferring pharmacy must notify the patient or patient's agent
of the transfer and must provide the patient or patient's agent with
the telephone number of the pharmacy receiving the multiple or bulk
prescription drug order records.
(h) 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 that 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) A pharmacy shall comply with 21 CFR 1305 regarding
the DEA order form (DEA 222) requirements when distributing a Schedule
II controlled substance.
(i) Other records. Other records to be maintained by
a pharmacy:
(1) a log of the initials or identification codes that
will identify each pharmacist, pharmacy technician, and pharmacy technician
trainee who is involved in the dispensing process, in the pharmacy's
data processing system (the initials or identification code shall
be unique to ensure that each individual can be identified, i.e.,
identical initials or identification codes shall not be used). Such
log shall be maintained at the pharmacy for at least seven years from
the date of the transaction;
(2) suppliers' invoices of dangerous drugs and controlled
substances; a pharmacist shall verify that the controlled substances
listed on the invoices were actually received by clearly recording
his/her initials and the actual date of receipt of the controlled
substances;
(3) suppliers' credit memos for controlled substances
and dangerous drugs;
(4) a copy of inventories required by §291.17
of this title (relating to Inventory Requirements);
(5) reports of surrender or destruction of controlled
substances and/or dangerous drugs to an appropriate state or federal
agency;
(6) records of distribution of controlled substances
and/or dangerous drugs to other pharmacies, practitioners, or registrants;
and
(7) a 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 the 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 that 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.
(j) 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 board. 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; and
(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 that 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; and
(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.
(k) Ownership of pharmacy records. For the purposes
of these sections, a pharmacy licensed under the Act is the only entity
that may legally own and maintain prescription drug records.
(l) Documentation of consultation. When a pharmacist,
pharmacist-intern, or pharmacy technician consults a prescriber as
described in this section, the individual shall document such occurrences
on the hard copy or in the pharmacy's data processing system associated
with the prescription and shall include the following information:
(1) date the prescriber was consulted;
(2) name of the person communicating the prescriber's
instructions;
(3) any applicable information pertaining to the consultation;
and
(4) initials or identification code of the pharmacist,
pharmacist-intern, or pharmacy technician performing the consultation
clearly recorded for the purpose of identifying the individual who
performed the consultation if the information is recorded on the hard
copy prescription.
|
| Source Note: The provisions of this §291.34 adopted to be effective September 14, 1988, 13 TexReg 4306; amended to be effective September 5, 1990, 15 TexReg 4807; amended to be effective March 18, 1991, 16 TexReg 1365; amended to be effective January 29, 1992, 17 TexReg 323; amended to be effective January 1, 1993, 17 TexReg 9116; amended to be effective September 30, 1993, 18 TexReg 6460; amended to be effective June 1, 1994, 19 TexReg 3921; amended to be effective March 29, 1995, 20 TexReg 1888; amended to be effective June 20, 1995, 20 TexReg 4121; amended to be effective March 21, 1996, 21 TexReg 2227; amended to be effective April 7, 1997, 22 TexReg 3106; amended to be effectiveMarch 29, 2000, 25 TexReg 2575; amended to be effective August 31, 2000, 25 TexReg 8405; amended to be effective March 7, 2001, 26 TexReg 1865; amended to be effective June 20, 2001, 26 TexReg 4478; amended to be effective June 1, 2002, 27 TexReg 1736; amended to be effective March 4, 2004, 29 TexReg 1951; amended to be effective June 6, 2004, 29 TexReg 5361; amended to be effective September 7, 2004, 29 TexReg 8516; amended to be effective March 10, 2005, 30 TexReg 1275; amended to be effective December 3, 2006, 31 TexReg 9610; amended to be effective March 25, 2007, 32 TexReg 1510; amended to be effective September 18, 2007, 32 TexReg 6319; amended to be effective March 6, 2008, 33 TexReg 1784; amended to be effective September 7, 2008, 33 TexReg 7218; amended to be effective June 7, 2009, 34 TexReg 3391; amended to be effective December 6,2009, 34 TexReg 8691; amended to beeffective March 11, 2010, 35 TexReg 2005; amended to be effective July 11, 2011, 36 TexReg 4402; amended to be effective November 24, 2011, 36 TexReg 7867; amended to be effective March 13, 2012, 37 TexReg 1705; amended to be effective June 7, 2012, 37 TexReg 4046; amended to be effective September 8, 2013, 38 TexReg 5722; amended to be effective September 11, 2014, 39 TexReg 7094; amended to be effective December 7, 2014, 39 TexReg 9345; amended to be effective June 12, 2016, 41 TexReg 4257; amended to be effective December 19, 2016, 41 TexReg 9934; amended to be effective September 6, 2017, 42 TexReg 4466; amended to be effective September 16, 2018, 43 TexReg 5784; amended to be effective December 6, 2018, 43 TexReg 7774; amended to be effective June 20, 2019, 44 TexReg 2946; amended to be effective March 5, 2020, 45 TexReg 1424; amended to be effective December 10, 2020, 45 TexReg8852;amended to be effective June 9, 2021, 46 TexReg 3520; amended to be effective December 7, 2021, 46 TexReg 8253; amended to be effective March 15, 2022, 47 TexReg 1277 |
