Part XV.
Texas State Board of Pharmacy
Chapter 281.
Administrative Practice and Procedures
Subchapter A. General Provisions
22 TAC §281.8, §281.17
The Texas State Board of Pharmacy proposes amendments to
§281.8, concerning Grounds for Discipline of a Pharmacy License and
proposes new rule §281.17, concerning Historically Underutilized Businesses.
The amendments to §281.8, if adopted, will clarify the action that may
result in the discipline of a pharmacy license. The 75th Texas Legislature
amended Section 26(b) of the Texas Pharmacy Act to add subsection (10), which
provides that the Board may discipline the holder of a pharmacy license if
the Board finds that the applicant or licensee has "engaged in any fraud,
deceit, or misrepresentation as defined by the rules adopted by the board
in operating a pharmacy or in seeking a license to operate a pharmacy." The
new rule §281.17, if adopted, will incorporate by reference the rules
adopted by the General Services Commission for historically underutilized
businesses and implements Section 124 of Article IX of the General Appropriations
Act adopted by the 75thTexas Legislature.
Gay Dodson, R.Ph., Executive Director/Secretary has determined that, for
the first five-year period the rule is in effect, there will be possible
fiscal implications for the state as a result of enforcing or administering
the amendment to rule 281.8. There are no anticipated fiscal implications
for local government.
For the amendment to rule 281.8, the fiscal implications for the state
are based on the cost of an enforcement action by the Texas State Board of
Pharmacy. Fiscal implications for the agency, based on an enforcement action,
are anticipated to be minimal because the enforcement and administration
of the proposed amendment to rule 281.8 can be adequately managed with existing
resources. In fiscal year 1997, the agency referred four cases for formal
hearings for which the State Office of Administrative Hearings billed the
Texas State Board of Pharmacy approximately $4,700.00. The agency cannot
accurately project whether the adoption of the proposed amendment, which
enumerates grounds for discipline of a pharmacy license, will increase the
number of complaints or the number of cases that may proceed to formal hearing.
Ms. Dodson also has determined that, for each year of the first five-year
period rule 281.8 will be in effect, the public benefit anticipated as a
result of enforcing the rule will be the protection of the public health,
safety and welfare because the proposed amendments to rule 281.8 add definitions
for the terms "fraud," "deceit," and "misrepresentation" as provided for
in section 26(b)(10) of the Texas Pharmacy Act and also clarifies other conduct
or action that may result in the discipline of a pharmacy license. The amendment
to rule 281.8 will result in a rule that is easier for the holders of pharmacy
licenses and the public to be aware of prohibited conduct.
The cost to small and large businesses, as well as persons required to
comply with rule 281.8, will be the costs of a possible violation of rule
281.8. A violation of rule 281.8 may result in a sanction imposed by the
Texas State Board of Pharmacy pursuant to section 28(a) of the Texas Pharmacy
Act.
Gay Dodson, R.Ph., Executive Director/Secretary has determined that, for
the first five-year period the rule is in effect, there will be no additional
fiscal implications for state or local government as a result of enforcing
or administering new rule 281.17.
For the amendment to rule 281.17, the fiscal implications for state and
local government are based on the fact that the agency must already comply
with the rules adopted by the General Services Commission for historically
underutilized businesses which implement Section 124 of Article IX of the
General Appropriations Act adopted by the 75th Texas Legislature.
Ms. Dodson also has determined that, for each year of the first five-year
period rule 281.17 will be in effect the public benefit as a result of enforcing
the rule will be the promotion of full and equal business opportunity for
all businesses in state contracting. There are no additional economic costs
anticipated for individuals or small or large businesses.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite
3-600, Box 21, Austin, Texas, 78701-3942.
The amendments are proposed under sections 4, 16(a), and 26(b)(10)
of the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes) and Section
124 of Article IX of the General Appropriations Act adopted by the 75th Texas
Legislature. The Board interprets section 4 as authorizing the agency to
adopt rules to protect the public health, safety, and welfare through the
effective control and regulation of the practice of pharmacy. The Board interprets
section 16(a) as authorizing the agency to adopt rules for the proper administration
and enforcement of the Act. The Board interprets section 26(b)(10) as authorizing
the agency to adopt rules to define "fraud," "deceit," and "misrepresentation"
in operating a pharmacy or in seeking a license to operate a pharmacy. The
Board interprets Section 124 of Article IX of the General Appropriations
Act adopted by the 75th Texas Legislature as requiring all state agencies
to adopt the General Services Commission's rules regarding historically underutilized
businesses.
The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1.
§281.8. Grounds for Discipline for a Pharmacy License.
(a)
For the purposes of
Section 26(b)(9) of
the Act
[
(1)
there is inadequate security to prevent unauthorized access
to prescription drugs;
or
(2)
there is inadequate security to prevent the diversion
of prescription drugs
.
[
(b)
For the purposes of Section 26(b)(3) of
the Act, it is grounds for discipline for a pharmacy license when:
(1)
[
(2)
[
(A)
prescription drugs provided by a manufacturer as starter
prescriptions or as replacement for such manufacturer's outdated drugs;
(B)
prescription drugs provided by a manufacturer in replacement
for such manufacturer's drugs that were dispensed pursuant to written starter
prescriptions; or
(C)
prescription drug samples possessed by a pharmacy of a
health care entity which provides health care primarily to indigent or low
income patients at no or reduced cost and if:
(i)
the samples are possessed in compliance with the Prescription
Drug Marketing Act of 1987;
(ii)
the pharmacy is owned by a charitable organization described
in the Internal Revenue Code of 1986, or by a city, state or county government;
and
(iii)
the samples are for dispensing or provision at no charge
to patients of such health care entity;
(3)
[
(A)
sold for export use only;
(B)
purchased by a public or private hospital or other health
care entity; or
(C)
donated or supplied at a reduced price to a charitable
organization described in the Internal Revenue Code of 1986, §501(c)(3),
and possessed by a pharmacy other than one owned by the charitable organization;
(D)
provided that subparagraphs (A)-(C) of this paragraph do
not apply to:
(i)
the purchase or other acquisition by a hospital or other
health care entity which is a member of a group purchasing organization or
from other hospitals or health care entities which are members of such organization;
(ii)
the sale, purchase, or trade of a drug or an offer to
sell, purchase, or trade a drug by an organization described in paragraph
(2)(C)(ii)
[
(iii)
the sale, purchase or trade of a drug or an offer to
sell, purchase, or trade a drug among hospitals or other health care entities
which are under common control;
(iv)
the sale, purchase, or trade of a drug or an offer to
sell, purchase, or trade a drug for emergency medical reasons including the
transfer of a drug between pharmacies to alleviate temporary shortages of
the drug arising from delays in or interruptions of regular distribution
schedules;
or
(v)
the dispensing of a prescription drug pursuant to a valid
prescription drug order to the extent otherwise permitted by law; [
(4)
[
(A)
misbranded prescription drugs; or
(B)
prescription drugs beyond the manufacturer's expiration
date
; or
[
(5)
For the purposes
of Section 26(b)(10) of the Act, the terms "fraud," "deceit," or "misrepresentation"
in operating a pharmacy or in seeking a license to operate shall be defined
as follows:
(A)
"Fraud" means an intentional perversion of truth
for the purpose of inducing another in reliance upon it to part with some
valuable thing belonging to him, or to surrender a legal right, or to issue
a license; a false representation of a matter of fact, whether by words or
by conduct, by false or misleading allegations, or by concealment of that
which should have been disclosed, which deceives or is intended to deceive
another;
(B)
"Deceit" means the assertion, as a fact, of
that which is not true by any means whatsoever to deceive or defraud another,
and
(C)
"Misrepresentation" means a manifestation by
words or other conduct which is a false representation of a matter of fact.
§281.17.Historically Underutilized Businesses.
The Texas State Board of Pharmacy adopts by reference the rules promulgated
by the General Services Commission, which are set forth in Subchapter B of
1 TAC §§111.11 - 111.24 regarding Historically Underutilized Business
Certification Program.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on March
5, 1999.
TRD-9901360
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 18, 1999
For further information, please call: (512) 305-8028
Subchapter A. All Classes of Pharmacies
22 TAC §§291.7, 291.8, 291.10, 291.17
The Texas State Board of Pharmacy proposes amendments to
§291.7, concerning Change of Pharmacist Employment, §291.8, concerning
Return of Prescription Drugs, §291.10, concerning Pharmacy Balance Registration/Inspection,
and §291.17, concerning Inventory Requirements. The amendments, if adopted,
will: (1) make a change in the notification requirement for a change of pharmacist-in-charge
consistent with the Texas Pharmacy Act; (2) clarify that a dispensed prescription
drug may not be returned to a pharmacy and re-dispensed; (3) clarify expiration
dates, registration requirements, and delete obsolete language concerning
prescription balances; and (4) clarify inventory requirements and make changes
necessary when butorphanol was scheduled as a controlled substance.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rule is in effect, there will be no fiscal
implications for state or local government as a result of enforcing or administering
the rule.
Ms. Dodson has determined that, for each year of the first five-year period
the rule will be in effect, the public benefit anticipated as a result of
enforcing the rule will be increased safety of the prescription drug supply
by clarifying the requirements for operation of a pharmacy. Since these proposed
amendments primarily clarify existing requirements or make them consistent
with other statutory or regulatory requirements, there are no additional
economic costs anticipated for individuals. Economic cost for licensed pharmacies
owned by both small and large businesses, as defined by section 2006.002
of the Texas Government Code, will be $12.50 for each additional prescription
balance registered.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite
3-600, box 21, Austin, Texas, 78701-3942.
The amendments are proposed under sections 4, 16(a), and 17(b)
of the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes). The Board
interprets section 4 as authorizing the agency to adopt rules to protect
the public health, safety, and welfare through the effective control and
regulation of the practice of pharmacy. The Board interprets section 16(a)
as authorizing the agency to adopt rules for the proper administration and
enforcement of the Act. The Board interprets section 17(b) as authorizing
the agency to regulate the delivery or distribution of prescription drugs
as they relate to the practice of pharmacy, specify the minimum standards
for the maintenance of prescription drug records, and register/inspect prescription
balances used for the compounding of drugs in pharmacies.
The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1.
§291.7.Change of Pharmacist Employment.
(a)
(No change.)
(b)
Change of pharmacist-in-charge of a pharmacy.
(1)-(3)
(No change.)
(4)
The incoming pharmacist-in-charge shall be responsible
for the following actions:
(A)-(B)
(No change.)
(C)
notifying the board
within 10 days
in writing
that a change of pharmacist-in-charge has occurred. The notification shall
include the following:
(i)-(iv)
(No change.)
§291.8.Return of Prescription Drugs.
(a)
In the interest of the public health of the state of Texas
and the possible adverse effects which the resale of drugs may have upon
the health of the public, the board hereby declares the following acts and
the causing thereof within the State of Texas to be unlawful and prohibited.
It shall be unlawful, after the effective date of this section, for any pharmacist
licensed by the board to accept any unused prescription or drug, in whole
or part, after it has been dispensed or sold, for the purpose of
re-dispensing
or
resale to any person.
(b)
(No change.)
§291.10.Pharmacy Balance Registration/Inspection.
(a)
(No change.)
(b)
Registration.
(1)
A pharmacy shall annually register each pharmacy balance
which may be
used in the compounding of drugs. The fee for the annual
registration shall be $12.50 per pharmacy balance.
(2)
[
[
(c)
(No change.)
§291.17.Inventory Requirements.
(a)
General requirements.
(1)
(No change.)
(2)
The inventory shall be maintained in a written, typewritten,
or printed form. An inventory taken by use of an oral recording device must
be promptly transcribed.
(3)-(4)
(No change.)
(5)
The inventory shall
be in a written, typewritten,
or printed form and
include all stocks of the following drugs on hand
on the date of the inventory (including any which are out-of-date):
(A)
all controlled substances;
(B)
[
[
all dosage forms containing nalbuphine (e.g.,
Nubain); and
(C)
[
(6)-(11)
(No change.)
(12)
If the pharmacy maintains a perpetual inventory of
any of the drugs required to be inventoried, the perpetual inventory shall
be reconciled on the date of the inventory.
(b)
Initial inventory.
(1)
A new Class A (community) pharmacy or Class C (institutional)
pharmacy shall take an inventory on the opening day of business. Such inventory
shall include all stocks (including any out-of-date drugs) of the following:
(A)
all controlled substances;
(B)
[
[
all dosage forms containing nalbuphine (e.g.,
Nubain); and
(C)
[
(2)-(3)
(No change.)
(c)
Annual inventory.
(1)
A Class A or C pharmacy shall take an inventory on May
1 of each year, or on the pharmacy's regular general physical inventory date.
Such inventory may be taken within four days of the specified inventory date
and shall include all stocks (including out-of-date drugs) of the following:
(A)
all controlled substances;
(B)
[
[
all dosage forms containing nalbuphine (e.g.,
Nubain); and
(C)
[
(2)
(No change.)
(d)
Change of ownership.
(1)
A Class A or C pharmacy that changes ownership shall take
an inventory of all of the following drugs on hand (including any which are
out-of-date) on the date of change of ownership:
(A)
all controlled substances;
(B)
[
[
all dosage forms containing nalbuphine (e.g.,
Nubain); and
(C)
[
(2)-(3)
(No change.)
(e)
(No change.)
(f)
Requirements for Class C (institutional) pharmacies.
(1)
Perpetual inventory.
(A)
A Class C pharmacy shall maintain a perpetual inventory
of all Schedule II controlled substances.
(B)
The perpetual inventory shall be reconciled on the date
of the annual inventory.
(2)
Annual inventory.
(A)
An inventory shall be conducted on May 1 of each year,
or on the pharmacy's regular general physical inventory date. Such inventory
may be taken within four days of the specified inventory date and shall
be in a written, typewritten, or printed form and
include all stocks
(including out-of-date drugs) of the following:
(i)
all controlled substances;
(ii)
[
[
all dosage forms containing nalbuphine
(e.g., Nubain); and
(iii)
[
(B)-(C)
(No change.)
(g)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on March
5, 1999.
TRD-9901361
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 18, 1999
For further information, please call: (512) 305-8028
Chapter 663.
Standards of Responsibility and Rules of Conduct
Subchapter B. Professional and Technical Standards
subdivision (9) of subsection (b) of § 26 of the
Act
], a pharmacy fails to establish and maintain effective controls
against diversion of prescription drugs when:
;
]
(3)
] during the time an individual's
license to practice pharmacy is revoked, canceled, or suspended, the pharmacy
employs or allows such individual access to prescription drugs;
(4)
] the pharmacy possesses
or engages in the sale, purchase, or trade or the offer to sell, purchase,
or trade prescription drug samples; provided however, this subparagraph does
not apply to:
(5)
] the pharmacy
possesses or engages in the sale, purchase, or trade or the offer to sell,
purchase, or trade of prescription drugs:
(4)(C)(ii)
] of this section to a nonprofit affiliate
of the organization to the extent otherwise permitted by law;
or
]
(6)
] the sale, purchase,
or trade or the offer to sell, purchase, or trade of:
.
]
Chapter 291.
Pharmacies
The annual registration fee for the 1995-1996
renewal cycle shall be prorated to establish staggered expiration dates which
coincide with the pharmacy license expiration date.
]
(3)
New registrations issued after September
1, 1995, shall be assigned an
]
The
expiration date
for pharmacy balance registrations shall coincide
[
that coincides
] with the pharmacy license expiration date.
all dosage forms containing butorphanol (e.g., Stadol);
]
(C)
]
(D)
] all dosage forms containing
carisoprodol (e.g., Soma).
all dosage forms containing butorphanol (e.g., Stadol);
]
(C)
]
(D)
] all dosage forms containing
carisoprodol (e.g., Soma).
all dosage forms containing butorphanol (e.g., Stadol);
]
(C)
]
(D)
] all dosage forms containing
carisoprodol (e.g., Soma).
all dosage forms containing butorphanol (e.g., Stadol);
]
(C)
]
(D)
] all dosage forms containing
carisoprodol (e.g., Soma).
all dosage forms containing butorphanol (e.g., Stadol);
]
(iii)
]
(iv)
] all dosage forms containing
carisoprodol (e.g., Soma).
Part XXIX.
Texas Board of Professional Land Surveying