Rule 20:67 WHOLESALE DRUG DISTRIBUTORS
Rule 20:67:01 DEFINITIONS
CHAPTER 20:67:01
DEFINITIONS
Section
20:67:01:01 Definitions.
Rule 20:67:01:01 Definitions.
20:67:01:01. Definitions. Words defined in SDCL 36-11A have the same meaning when used in this article. In addition, terms used in this article mean:
(1) "Applicant,"
a wholesale drug distributor, as provided in SDCL 36-11A-3, represented by a person, including a proprietor, partner, corporate officer or director, or contact person, authorized to complete the application form and certifications;
(2) "DEA," the federal drug enforcement administration; and
(3) "Controlled room
temperature," a temperature maintained thermostatically between 15 and 30
degrees centigrade or 59 and 86 degrees Fahrenheit.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14.
Law
Implemented:SDCL 36-11A-7.
Rule 20:67:02 LICENSURE REQUIREMENTS
CHAPTER 20:67:02
LICENSURE REQUIREMENTS
Section
20:67:02:01 Application and fee.
20:67:02:02 Required
application information.
20:67:02:03 Licensure required for each location --
Out-of-state exemption.
20:67:02:04 Supplemental application information.
20:67:02:05 Controlled substance registration
required.
20:67:02:06 Personnel requirements.
20:67:02:07 Denial of licensure when not in public
interest.
20:67:02:08 Information on changes to be reported.
20:67:02:09 Temporary license valid for 90 days --
No refund.
20:67:02:10 Out-of-state wholesale drug distributor
application -- Other state license required.
20:67:02:11 Reciprocal cooperation extended.
20:67:02:12 Exemption allowed.
Rule 20:67:02:01 Application and fee.
20:67:02:01. Application and fee. A wholesale distributor
must apply each year to the board, on a form supplied by the secretary of the
board, for a license to engage in distribution of prescription drugs. Each
application shall be accompanied by a license fee of $200.
Source:
18 SDR 95, effective November 25, 1991; 24 SDR 160, effective May 26, 1998.
General
Authority:SDCL 36-11A-14(1),(6).
Law
Implemented:SDCL 36-11A-7, 36-11A-8.
Rule 20:67:02:02 Required application information.
20:67:02:02. Required application information. Applicants
must complete the following information as part of the application form:
(1) The name, full business
address, and telephone number of the applicant;
(2) All trade or business
names used by the applicant;
(3) Address, telephone
numbers, and the name of contact person for the facility used by the applicant
for the storage, handling, and distribution of prescription drugs;
(4) The type of ownership
or operation, that is, partnership, corporation, or sole proprietorship;
(5) The name of the owner
or operator, or both, of the applicant, including:
(a) If a person, the
name of the person;
(b) If a partnership,
the name of each partner and the name of the partnership;
(c) If a corporation,
the name and title of each corporate officer and director, the corporate names,
the name of the state of incorporation, and the name of any parent company;
(d) If a sole
proprietorship, the full name of the sole proprietor and the name of the business
entity;
(6) Statements pertaining
to factors that may determine eligibility for licensure, including:
(a) Any convictions of
the applicant under any federal, state, or local laws relating to drug samples,
wholesale or retail drug distribution, or distribution of controlled
substances;
(b) Any felony
convictions of the applicant under federal, state, or local laws;
(c) The applicant's
past experience in the manufacture or distribution of prescription drugs,
including controlled substances;
(d) Suspension or
revocation by federal, state, or local government of any license currently or
previously held by the applicant for the manufacture or distribution of any
drugs, including controlled substances; and
(7) A statement certifying
that the applicant will operate in a manner prescribed by federal and state law
and rules adopted by the board.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(1),(3).
Law
Implemented:SDCL 36-11A-7, 36-11A-8.
Rule 20:67:02:03 Licensure required for each location -- Out-of-state exemption.
20:67:02:03. Licensure required for each location --
Out-of-state exemption. Separate licensure is required where separate
operations are conducted at more than one location within this state by a
single wholesale distributor. Out-of-state wholesale drug distributors shipping
drugs into this state who do not maintain or operate a
physical facility within the state are not required to license each separate
location from which drugs are shipped to this state, but may instead obtain
licensure for the primary location of the parent entity with divisions,
subsidiaries, or affiliate companies.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(1).
Law
Implemented:SDCL 36-11A-7, 36-11A-9.
Rule 20:67:02:04 Supplemental application information.
20:67:02:04. Supplemental application information. In
order to more fully consider qualifications of an applicant, the board may
request supplemental information on records that are not a part of the
application form.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(1) to (3).
Law
Implemented:SDCL 36-11A-7, 36-11A-8, 36-11A-12.
Rule 20:67:02:05 Controlled substance registration required.
20:67:02:05. Controlled substance registration required.
Wholesale drug distributors that deal in controlled substances shall register
with the South Dakota department of health and with the DEA
and shall comply with all applicable state, local, and DEA
regulations.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(3).
Law
Implemented:SDCL 36-11A-7, 36-11A-12.
Cross-Reference:
Annual registration of manufacturers, distributors and dispensers required, SDCL 34-20B-29.
Rule 20:67:02:06 Personnel requirements.
20:67:02:06. Personnel requirements. As a condition for
receiving and retaining a license, wholesale drug distributors shall employ
sufficient numbers of personnel with education, training, and experience, or
any combination thereof, so that all assigned functions are performed in a
manner that assures that drug product quality, safety, and security will at all
times be maintained as required by law. Lists of officers, directors, managers,
and other persons in charge of wholesale drug distribution, storage, and
handling, including a description of their duties and a summary of their
qualifications, shall be established and maintained.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(3),(11).
Law
Implemented:SDCL 36-11A-7.
Rule 20:67:02:07 Denial of licensure when not in public interest.
20:67:02:07. Denial of licensure when not in public interest.
The board may deny a license to an applicant if it determines that the granting
of such a license would not be in the public interest based on health, safety,
and welfare considerations, including:
(1) The furnishing by the
applicant of false or fraudulent material in any application made in connection
with drug manufacturing or distribution;
(2) Compliance with
licensing requirements under previously granted licenses;
(3) Compliance with the
requirements to maintain or make available to the board or to federal, state,
or local law enforcement officials those records required to be maintained by
wholesale drug distributors.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(1),(3).
Law
Implemented:SDCL 36-11A-12.
Cross-Reference:
Record keeping, ch 20:67:04.
Rule 20:67:02:08 Information on changes to be reported.
20:67:02:08. Information on changes to be reported.
Changes in any information required in this chapter shall be submitted to the
secretary of the board within 60 days with the exception of routine changes in
the names and titles of corporate officers and directors, which may be reported
upon license renewal.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(1),(11).
Law
Implemented:SDCL 36-11A-7, 36-11A-12.
Rule 20:67:02:09 Temporary license valid for 90 days -- No refund.
20:67:02:09. Temporary license valid for 90 days -- No
refund. Upon the request of the applicant and receipt of a completed
application and the license fee as provided in § 20:67:02:01, the
secretary of the board may issue a letter granting temporary licensure provided
that information contained on the application form shows no apparent reason for
denial of licensure and the board has not previously denied, suspended, or
revoked a license of the applicant.
The board shall approve or deny the
application for license within 90 days after receipt of the application. Upon
approval or notice of denial, the temporary license becomes void unless the
applicant appeals the decision of the board pursuant to SDCL chapter 1-26. If a temporary license is issued, the license fee may not be refunded if the application is subsequently denied by the board.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(1),(3),(4).
Law
Implemented:SDCL 36-11A-7, 36-11A-10.
Rule 20:67:02:10 Out-of-state wholesale drug distributor application -- Other state license required.
20:67:02:10. Out-of-state wholesale drug distributor
application -- Other state license required. Out-of-state wholesale drug
distributors must meet the application and fee requirements of this chapter and
must also submit a copy of their wholesale drug distributor's license or its
equivalent from the state in which the distributor is located if a license is
issued by that state.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(1).
Law
Implemented:SDCL 36-11A-7, 36-11A-11.
Rule 20:67:02:11 Reciprocal cooperation extended.
20:67:02:11. Reciprocal cooperation extended. The board
shall cooperate with other states that license and regulate wholesale drug or
pharmacy distributors to verify information contained on license applications
and for the purpose of investigating complaints against distributors located in
this state or the sharing of inspection reports, investigative reports, or
licensure status if the other state extends the same reciprocal cooperation to
the board.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(5).
Law
Implemented:SDCL 36-11A-11.
Rule 20:67:02:12 Exemption allowed.
20:67:02:12. Exemption allowed. An exemption to licensure
is allowed when an out-of-state wholesale drug distributor supplies a drug to
another drug distributor licensed in this state in an emergency. The amount of
the distribution allowed is confined to the emergency.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(1).
Law
Implemented:SDCL 36-11A-2(5).
Rule 20:67:03 DRUG STORAGE AND HANDLING REQUIREMENTS
Rule 20:67:03:01 Facilities.
20:67:03:01. Facilities. All facilities at which
prescription drugs are stored, warehoused, handled, held, offered, marketed, or
displayed shall meet the following conditions:
(1) Be of suitable size and
construction to facilitate cleaning, maintenance, and proper operations;
(2) Have storage areas
designed to provide adequate lighting, ventilation, temperature, sanitation,
humidity, space, equipment, and security conditions;
(3) Have a separate
quarantine area for storage of prescription drugs that are outdated, damaged,
deteriorated, misbranded, or adulterated or that are in immediate or sealed
secondary containers that have been opened;
(4) Be maintained in a
clean and orderly condition;
(5) Be free from
infestation by insects, rodents, birds, or vermin of any kind;
(6) Be secured from
unauthorized entry by:
(a) A well-lighted
outside perimeter of the premises;
(b) An alarm system to
detect entry after hours; and
(c) A security system
that provides protection against theft and diversion, including, if applicable,
theft or diversion that is facilitated or hidden by tampering with computers or
electronic records.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(7),(10).
Law
Implemented:SDCL 36-11A-7.
Rule 20:67:03:02 Storage conditions.
20:67:03:02. Storage conditions. All prescription drugs
shall be stored as required by the labeling of the drugs. If no storage
requirements are established for a prescription drug, the drug may be held at
controlled room temperature to help ensure that its identity, strength,
quality, and purity are not adversely affected. Manual, electromechanical, or
electronic temperature and humidity recording equipment, devices, or logs shall
be utilized, as applicable, to document proper storage of prescription drugs.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(7).
Law
Implemented:SDCL 36-11A-7.
Rule 20:67:03:03 Examination upon receipt required.
20:67:03:03. Examination upon receipt required. Upon
receipt, each outside shipping container shall be visually examined for
identity and to prevent the acceptance of contaminated prescription drugs or
prescription drugs that are otherwise unfit for distribution. This examination
must be adequate to reveal container damage that would suggest possible
contamination or other damage to the contents.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(7),(13).
Law
Implemented:SDCL 36-11A-7.
Rule 20:67:03:04 Outgoing shipments to be inspected.
20:67:03:04. Outgoing shipments to be inspected. Each
outgoing shipment shall be carefully inspected for identity of the prescription
drug products and to ensure that there is no delivery of prescription drugs
that have been damaged in storage or held under improper conditions.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(7),(13).
Law
Implemented:SDCL 36-11A-7.
Rule 20:67:03:05 Quarantine required.
20:67:03:05. Quarantine required. Prescription drugs that
are outdated, damaged, deteriorated, misbranded, or adulterated shall be
quarantined and physically separated from other prescription drugs until they
are destroyed or returned to their supplier.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(7).
Law
Implemented:SDCL 36-11A-7.
Rule 20:67:03:06 Opened containers to be identified.
20:67:03:06. Opened containers to be identified. Any
prescription drugs whose immediate or sealed outer or sealed secondary
containers have been opened or used shall be identified as such and shall be
quarantined and physically separated from other prescription drugs until they
are either destroyed or returned to the supplier.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(7),(13).
Law
Implemented:SDCL 36-11A-7.
Rule 20:67:03:07 Standards for returned drugs to be met.
20:67:03:07. Standards for returned drugs to be met. If
the conditions under which a prescription drug has been returned cast doubt on
the drug's safety, identity, strength, quality, or purity, the drug shall be
destroyed or returned to the supplier, unless examination, testing, or other
investigation proves that the drug meets standards of safety, identity,
strength, quality, and purity. In determining whether the conditions under
which a drug has been returned cast doubt on the drug's safety, identity, strength,
quality, or purity, the wholesale drug distributor shall consider, among other
things, the conditions under which the drug has been held, stored, or shipped
before or during its return and the condition of the drug and its container,
carton, or labeling as a result of storage or shipping.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(7),(13).
Law
Implemented:SDCL 36-11A-7.
Rule 20:67:04 RECORD KEEPING
Rule 20:67:04:01 Record keeping.
20:67:04.01. Record keeping. Wholesale drug distributors
shall establish and maintain inventories and records of all transactions
regarding the receipt and distribution or other disposition of prescription
drugs, including outdated drugs. These records shall include the following
information:
(1) The source of the
drugs, including the name and principal address of the seller or transferor,
and the address of the location from which the drugs were shipped;
(2) The identity and
quantity of the drugs received and distributed or disposed of;
(3) The dates of receipt
and distribution or other disposition of the drugs; and
(4) Documentation of
storage conditions as required in §20:67:03:02.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(8).
Law
Implemented:SDCL 36-11A-7.
Rule 20:67:04:02 Retention and inspection of records.
20:67:04.02. Retention and inspection of records.
Inventories and records required by this chapter may be maintained by manual or
electronic means in a form that allows inspection and photocopying of requested
records during inspections. All records shall be retained for two years
following disposition of the drugs.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(8),(14).
Law
Implemented:SDCL 36-11A-16, 36-11A-17.
Rule 20:67:04:03 Retrieval of records.
20:67:04.03. Retrieval of records. Records described in
this chapter that are kept at the inspection site at a central location apart
from the inspection site or that can be immediately retrieved by computer or
other electronic means shall be readily available for authorized inspection
during the retention period.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(8),(14).
Law
Implemented:SDCL 36-11A-7, 36-11A-17.
Rule 20:67:04:04 Financial records treated as confidential materials.
20:67:04.04. Financial records treated as confidential
materials. Any financial records inspected or photocopied by the board
shall be treated as confidential materials and not open to public inspection.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(2),(13).
Law
Implemented:SDCL 36-11A-16.
Rule 20:67:05 POLICIES AND PROCEDURES
CHAPTER 20:67:05
POLICIES AND PROCEDURES
Section
20:67:05:01 Policies and procedures to be
established.
Rule 20:67:05:01 Policies and procedures to be established.
20:67:05:01. Policies and procedures to be established.
Wholesale drug distributors shall establish, maintain, and adhere to written
policies and procedures for the receipt, security, storage, inventory, and
distribution of prescription drugs, including policies and procedures for
identifying, recording, and reporting losses or thefts and for correcting all
errors and inaccuracies in inventories. Wholesale drug distributors shall
include in their written policies and procedures the following:
(1) A procedure whereby the
oldest approved stock of a prescription drug product is distributed first. The
procedure may permit deviation from this requirement if the deviation is
temporary;
(2) A procedure to be
followed for handling recalls and withdrawals of prescription drugs due to:
(a) Any action
initiated at the request of the food and drug administration or any other
federal, state, or local law enforcement or governmental agency, including the
board;
(b) Any voluntary
action by the manufacturer to remove defective or potentially defective drugs
from the market;
(c) Any action
undertaken to promote public health and safety by the replacing of existing
merchandise with an improved product or new package design;
(3) A procedure to ensure
that wholesale drug distributors prepare for, protect against, and handle any
crisis that affects security or operation of any facility in the event of
strike, fire, flood, or other natural disaster or other situations of local,
state, or national emergency;
(4) A procedure to ensure
that any outdated prescription drugs are segregated from other drugs and either
returned to the manufacturer or destroyed. This procedure shall provide for
written documentation of the disposition of outdated prescription drugs;
(5) A procedure to keep
access from outside the premises to a minimum and well controlled; and
(6) A procedure to limit
entry into areas where prescription drugs are held to authorized personnel
only.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(7),(10),(12).
Law
Implemented:SDCL 36-11A-7.
Rule 20:67:06 INSPECTIONS
CHAPTER 20:67:06
INSPECTIONS
Section
20:67:06:01 Regular inspections required.
20:67:06:02 Exemption from inspection.
20:67:06:03 Out-of-state wholesale drug distributor
exemption.
Rule 20:67:06:01 Regular inspections required.
20:67:06:01. Regular inspections required. Wholesale drug
distributors located within the state shall be inspected by the board every two
years with follow-ups if problems are found. The following areas may be
reviewed when inspections are performed:
(1) Responsibility for
operation;
(2) Policies and
procedures;
(3) Purchases and sales;
(4) Record keeping;
(5) Recalls;
(6) Facilities;
(7) Security;
(8) Storage conditions; and
(9) Returned goods.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(14).
Law
Implemented:SDCL 36-11A-7, 36-11A-16.
Rule 20:67:06:02 Exemption from inspection.
20:67:06:02. Exemption from inspection. Wholesale drug
distributors that have received a satisfactory rating as the result of a full
inspection of all operations and procedures by the food and drug administration
are exempt from further inspection by the board until any subsequent inspection
results in a less than satisfactory rating or until two or more years have
passed since the last full inspection by the food and drug administration. Less
than satisfactory ratings may include documentation of deficiencies in any drug
distribution, repackaging, labeling, quality control, or environmental
policies. Deficiencies include any statement which is a part of a compliance
report recorded by federal inspection with or without sanctions, penalties,
fines, or discipline imposed.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(14).
Law
Implemented:SDCL 36-11A-7.
Rule 20:67:06:03 Out-of-state wholesale drug distributor exemption.
20:67:06:03. Out-of-state wholesale drug distributor
exemption. The board may exempt from inspection any out-of-state wholesale
drug distributor pursuant to § 20:67:06:02 on demonstration of a
satisfactory rating on an equivalent inspection conducted by the licensing
agency of the state where the distributor is located.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(14).
Law
Implemented:SDCL 36-11A-7, 36-11A-11, 36-11A-16.
Rule 20:67:07 DUE PROCESS
CHAPTER 20:67:07
DUE PROCESS
Section
20:67:07:01 Designation of registered agent.
Rule 20:67:07:01 Designation of registered agent.
20:67:07:01. Designation of registered agent.
Out-of-state drug wholesaler distributors shall designate a resident agent in
this state for service of process. If an agent is not designated, the secretary
of state of this state shall be considered to be its true and lawful agent,
upon whom may be served all legal process in any
action or proceeding against the out-of-state wholesale drug distributor. A
copy of any service of process shall be mailed by certified mail, return
receipt requested, postage prepaid, at the address the out-of-state wholesale
drug distributor has designated on its application for licensure. If any
out-of-state wholesale drug distributor is not licensed in this state, service
on the secretary of state is sufficient service.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(15).
Law
Implemented:SDCL 36-11A-7, 36-11A-19.
Rule 20:67:08 WHOLESALE DRUG ADVISORY COMMITTEE
CHAPTER 20:67:08
WHOLESALE DRUG ADVISORY COMMITTEE
Section
20:67:08:01 Terms to begin on July 1.
20:67:08:02 Applicants to be solicited for
recommendations.
20:67:08:03 Recommendations to remain on file.
20:67:08:04 Board to review recommendations on file.
20:67:08:05 Unexpired terms
to be filled within three months of vacancy.
20:67:08:06 Appointees to indicate willingness to
serve.
Rule 20:67:08:01 Terms to begin on July 1.
20:67:08:01. Terms to begin on July 1. Terms of new
wholesale drug advisory committee members shall begin on July 1 unless the
appointment is to fill an unexpired term.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(16).
Law
Implemented:SDCL 36-11A-7, 36-11A-15.
Rule 20:67:08:02 Applicants to be solicited for recommendations.
20:67:08:02. Applicants to be solicited for recommendations.
Each year, along with the application for wholesale drug distributor and
pharmacy license renewal, the secretary of the board shall send a solicitation
of recommendation for persons to serve on the wholesale drug advisory
committee. The solicitation shall include the following:
(1) A list of committee
members and the group represented by each member;
(2) The term expiration for
each member;
(3) A request for
recommendations to fill terms expiring during the licensing year; and
(4) A reprint of SDCL 36-11A-15 and this article.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(16).
Law
Implemented:SDCL 36-11A-7, 36-11A-15.
Rule 20:67:08:03 Recommendations to remain on file.
20:67:08:03. Recommendations to remain on file. The board
shall maintain a file of recommendations for wholesale drug advisory committee
membership and shall hold each recommendation until December 31 of the year
following its receipt.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(16).
Law
Implemented:SDCL 36-11A-15.
Rule 20:67:08:04 Board to review recommendations on file.
20:67:08:04. Board to review recommendations on file. The
board may consider recommendations received to fill all expired or unexpired
terms. Appointments to fill expiring terms shall be made prior to expiration of
the terms.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(16).
Law
Implemented:SDCL 36-11A-15.
Rule 20:67:08:05 Unexpired terms to be filled within three months of vacancy.
20:67:08:05. Unexpired terms to be filled within three months
of vacancy. If an unexpired term is created by death, incapacity, or
written notice, the board shall appoint a person to complete the expired term
within three months after receipt of notice.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(16).
Law
Implemented:SDCL 36-11A-15.
Rule 20:67:08:06 Appointees to indicate willingness to serve.
20:67:08:06. Appointees to indicate willingness to serve.
Any person appointed to the wholesale drug advisory committee shall, prior to
appointment, indicate in writing to the board a willingness to serve as a
committee member.
Source:
18 SDR 95, effective November 25, 1991.
General
Authority:SDCL 36-11A-14(16).
Law
Implemented:SDCL 36-11A-15.
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20:67 