| (I) In the event that an FEMCF pharmacy which uses
a data processing system experiences system downtime, the pharmacy
must have an auxiliary procedure which will ensure that all data is
retained for online data entry as soon as the system is available
for use again.
(4) 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.
(A) The registrant to whom the controlled substance
is to be distributed is registered under the Controlled Substances
Act to possess that controlled substance.
(B) The total number of dosage units of controlled
substances distributed by a pharmacy may not exceed 5.0% of all controlled
substances dispensed 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.
(C) If the distribution is for a Schedule III, IV,
or V controlled substance, a record shall be maintained which indicates:
(i) the actual date of distribution;
(ii) the name, strength, and quantity of controlled
substances distributed;
(iii) the name, address, and DEA registration number
of the distributing pharmacy; and
(iv) the name, address, and DEA registration number
of the pharmacy, practitioner, or other registrant to whom the controlled
substances are distributed.
(D) A pharmacy shall comply with 21 CFR 1305 regarding
the DEA order form (DEA 222) requirements when distributing a Schedule
II controlled substance.
(5) Other records. Other records to be maintained by
the pharmacy include:
(A) a permanent log of the initials or identification
codes which identifies each 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 cannot be used;
(B) suppliers' invoices of dangerous drugs and controlled
substances dated and initialed or signed by the person receiving the
drugs;
(i) a pharmacist shall verify that the controlled substances
listed on the invoices were added to the pharmacy's perpetual inventory
by clearly recording his/her initials and the date of review of the
perpetual inventory; and
(ii) for controlled substances, the documents retained
must contain the name, strength and quantity of controlled substances
distributed, and the name, address and DEA number of both registrants;
the supplier and the receiving pharmacy;
(C) supplier's credit memos for controlled substances
and dangerous drugs;
(D) a copy of inventories required by §291.17
of this title (relating to Inventory Requirements) except that a perpetual
inventory of controlled substances listed in Schedule II may be kept
in a data processing system if the data processing system is capable
of producing a hard copy of the perpetual inventory on site;
(E) reports of surrender or destruction of controlled
substances and/or dangerous drugs to an appropriate state or federal
agency or reverse distributor;
(F) records of distribution of controlled substances
and/or dangerous drugs to other pharmacies, practitioners, or registrants;
and
(G) a copy of any notification required by the Texas
Pharmacy Act or these rules, including, but not limited to, the following:
(i) reports of theft or significant loss of controlled
substances to DEA and the board;
(ii) notification of a change in pharmacist-in-charge
of a pharmacy; and
(iii) 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.
(6) Permission to maintain central records. Any pharmacy
that uses a centralized recordkeeping system for invoices and financial
data shall comply with the following procedures.
(A) Controlled substance records. Invoices and financial
data for controlled substances may be maintained at a central location
provided the following conditions are met:
(i) 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(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;
(ii) The pharmacy maintains a copy of the notification
required in this subparagraph; and
(iii) 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.
(B) Dangerous drug records. Invoices and financial
data for dangerous drugs may be maintained at a central location.
(C) 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.
(D) 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.
|
| Source Note: The provisions of this §291.151 adopted to be effective March 11, 2010, 35 TexReg 2005; amended to be effective September 14, 2010, 35 TexReg 8358; amended to be effective March 10, 2011, 36 TexReg 1547; amended to be effective September 11, 2014, 39 TexReg 7129; amended to be effective December 6, 2015, 40 TexReg 8780; amended to be effective September 11, 2016, 41 TexReg 6737; amended to be effective June 7, 2018, 43 TexReg 3592; amended to be effective June 20, 2019, 44 TexReg 2952; amended to be effective September 9, 2021, 46 TexReg 5560; amended to be effective August 27, 2023, 48 TexReg 4671 |
