| (A) Prescription drug orders may not be transferred
by non-electronic means during periods of downtime except on consultation
with and authorization by a prescribing practitioner; provided however,
during downtime, a hard copy of a prescription drug order may be made
available for informational purposes only, to the patient or a pharmacist,
and the prescription may be read to a pharmacist by telephone.
(B) The original prescription drug order shall be invalidated
in the data processing system for purposes of filling or refilling,
but shall be maintained in the data processing system for refill history
purposes.
(C) If the data processing system does not have the
capacity to store all the information as specified in paragraphs (5)
and (6) of this subsection, the pharmacist is required to record this
information on the original or transferred prescription drug order.
(D) The data processing system shall have a mechanism
to prohibit the transfer or refilling of controlled substance prescription
drug orders that have been previously transferred.
(E) Pharmacies electronically accessing the same prescription
drug order records may electronically transfer prescription information
if the following requirements are met.
(i) The original prescription is voided and the pharmacies'
data processing systems shall store all the information as specified
in paragraphs (5) and (6) of this subsection.
(ii) Pharmacies not owned by the same person may electronically
access the same prescription drug order records, provided the owner,
chief executive officer, or designee of each pharmacy signs an agreement
allowing access to such prescription drug order records.
(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 done in a timely manner. 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.
(10) 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 section 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) 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 permanent log of the initials or identification
codes that will identify each pharmacist, pharmacy technician, and
pharmacy technician trainee by name performing data entry of prescription
information (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);
(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 hard 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 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) a hard copy of 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 hard 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.
Cont'd... |
