| (D) the name, address, and DEA registration number
of the pharmacy, practitioner, or other registrant to whom the controlled
substances are distributed.
(4) If the distribution is for a Schedule II controlled
substance, the following is applicable.
(A) The pharmacy, practitioner, or other registrant
who is receiving the controlled substances shall issue Copy 1 and
Copy 2 of a DEA order form (DEA 222) to the distributing pharmacy.
(B) The distributing pharmacy shall:
(i) complete the area on the DEA order form (DEA 222)
titled "To Be Filled in by Supplier";
(ii) maintain Copy 1 of the DEA order form (DEA 222)
at the pharmacy for two years; and
(iii) forward Copy 2 of the DEA order form (DEA 222)
to the Divisional Office of the Drug Enforcement Administration.
(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) Copy 3 of DEA order form (DEA 222) that has been
properly dated, initialed, and filed, and all copies of each unaccepted
or defective order form and any attached statements or other documents
and/or for each order filled using the DEA Controlled Substance Ordering
System (CSOS) the original signed order and all linked records for
that order;
(3) a copy of the power of attorney to sign DEA 222
order forms (if applicable);
(4) suppliers' invoices of dangerous drugs and 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 copy of inventories required by §291.17
of this title (relating to Inventory Requirements);
(7) reports of surrender or destruction of controlled
substances and/or dangerous drugs to an appropriate state or federal
agency;
(8) the Schedule V nonprescription register book;
(9) records of distribution of controlled substances
and/or dangerous drugs to other pharmacies, practitioners, or registrants;
and
(10) 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 DEA, Department of Public Safety, 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 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.
(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, 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.
(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
consults a prescriber as described in this section, the pharmacist
shall document on the hard copy or in the pharmacy's data processing
system associated with the prescription such occurrences 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
performing the consultation clearly recorded for the purpose of identifying
the pharmacist 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 effectiveMarch29, 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 be effectiveMarch 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 |
