The sale or transfer from a retail pharmacy or chain pharmacy warehouse of expired,
damaged, returned, or recalled prescription drugs to the original manufacturer or to a third
party returns processor.
Wholesale distributor license required--Exemptions.
Any wholesale distributor
who engages in the wholesale distribution of prescription drugs in this state must be licensed by the
board, in accordance with §§ 36-11A-20 to 36-11A-46, inclusive, before engaging in wholesale
distributions of wholesale prescription drugs. The board shall exempt manufacturers distributing
their own FDA-approved drugs and devices from any qualifications required for licensing, to the
extent not required by federal law or regulation, including the requirements in subdivisions 36-11A-28(7) and (8), and §§ 36-11A-29 to 36-11A-31, inclusive.
Source: SL 2007, ch 215, § 9.
36-11A-28 Information to be provided by applicants.
Information to be provided by applicants.
The board shall require the following
minimum information from each wholesale distributor applying to obtain a license under § 36-11A-27:
The name, full business address, and telephone number of the licensee;
Any trade or business name used by the licensee;
The address, telephone number, and the name of any contact person for any facilities used
by the licensee for the storage, handling, and distribution of prescription drugs;
The type of ownership or operation;
The name of the owner and the operator of the licensee, including:
If a person, the name of the person;
If a partnership, the name of each partner, and the name of the partnership;
If a corporation, the name and title of each corporate officer and director, the
corporate names, and the name of the state of incorporation; and
If a sole proprietorship, the full name of the sole proprietor and the name of the
A list of all licenses and permits issued to the applicant by any other state that authorizes
the applicant to purchase or possess prescription drugs;
The name of the applicant's designated representative for the facility, together with the
personal information statement and fingerprints, required pursuant to subdivision (8) for
Each person required by subdivision (7) to provide a personal information statement and
fingerprints, if required, shall provide the following information to the board:
The person's places of residence for the past seven years;
The person's date and place of birth;
The person's occupations, positions of employment, and offices held during the
past seven years;
The principal business and address of any business, corporation, or other
organization in which each such office of the person was held or in which each
such occupation or position of employment was carried on;
Whether the person has been, during the past seven years, the subject of any
proceeding for the revocation of any license or any criminal violation and, if so, the
nature of the proceeding and the disposition of the proceeding;
Whether, during the past seven years, the person has been enjoined, either
temporarily or permanently, by a court of competent jurisdiction from violating any
federal or state law regulating the possession, control, or distribution of
prescription drugs or had any criminal violations of such laws, together with details
concerning any such event;
A description of any involvement by the person with any business, including any
investments, other than the ownership of stock in a publicly traded company or
mutual fund, during the past seven years, which manufactured, administered,
prescribed, distributed, or stored pharmaceutical products and any lawsuits in
which such businesses were named as a party;
A description of any misdemeanor or felony criminal offense of which the person,
as an adult, was found guilty, regardless of whether adjudication of guilt was
withheld or whether the person pled guilty or nolo contendere. If the person
indicates that a criminal conviction is under appeal and submits a copy of the
notice of appeal of that criminal offense, the applicant shall, within fifteen days
after the disposition of the appeal, submit to the board a copy of the final written
order of disposition; and
A photograph of the person taken in the previous one hundred eighty days.
The information required pursuant to this section shall be provided under oath.
SL 2007, ch 215, § 10.
36-11A-29 Inspection of facility--Qualifications of designated representative.
Inspection of facility--Qualifications of designated representative.
The board may
not issue a wholesale distributor license to an applicant, unless the board or a nationally recognized
accreditation program approved by the board:
Conducts a physical inspection of the facility at the address provided by the applicant as
required in subdivision 36-11A-28(1); and
Determines that the designated representative meets the following qualifications:
Is at least twenty-one years of age;
Has been employed full time for at least three years in a pharmacy or with a
wholesale distributor in a capacity related to the dispensing and distribution of, and
recordkeeping relating to, prescription drugs;
Is employed by the applicant full time in a managerial level position;
Is actively involved in and aware of the actual daily operation of the wholesale
Is physically present at the facility of the applicant during regular business hours,
except when the absence of the designated representative is authorized, including
sick leave and vacation leave;
Is serving in the capacity of a designated representative for only one applicant at
a time, except where more than one licensed wholesale distributor is co-located in
the same facility and such wholesale distributors are members of an affiliated
group, as defined in Section 1504 of the Internal Revenue Code;
Does not have any convictions under any federal, state, or local laws relating to
wholesale or retail prescription drug distribution or distribution of controlled
Does not have any felony convictions under federal or state laws.
SL 2007, ch 215, § 11.
36-11A-30 Criminal record check.
Criminal record check.
The board may require the applicant to submit the
fingerprints provided by a person with a license application for a statewide criminal record check
and for forwarding to the Federal Bureau of Investigation for a national criminal record check of the
Source: SL 2007, ch 215, § 12.
36-11A-31 Bond or other security required--Purpose--Exemption--License required for each facility.
Bond or other security required--Purpose--Exemption--License required for each
The board shall require every wholesale distributor applying for a license to submit a bond
of at least one hundred thousand dollars, or other equivalent means of security acceptable to the
board, such as an irrevocable letter of credit or a deposit in a trust account or financial institution,
payable to a fund established by the board. The board shall establish a fund, separate from its other
accounts, in which to deposit the wholesale distributor bonds. Any chain pharmacy warehouse that
is not engaged in wholesale distribution is exempt from the bond requirement. The purpose of the
bond is to secure payment of any fines or penalties imposed by the board and any fees and costs
incurred by the board regarding that license, which are authorized pursuant to statute and which the
licensee fails to pay thirty days after the fines, penalties, or costs become final. The board may make
a claim against such bond or security until one year after the licensee's license ceases to be valid. A
single bond may suffice to cover all facilities operated by the applicant in the state.
If a wholesale distributor distributes prescription drugs from more than one facility, the
wholesale distributor shall obtain a license for each facility.
Source: SL 2007, ch 215, § 13.
36-11A-32 Changes or corrections to required information--Suspension or revocation of license.
Changes or corrections to required information--Suspension or revocation of
In accordance with each licensure renewal, the board shall send to each wholesale distributor
licensed under § 36-11A-27 a form setting forth the information that the wholesale distributor
provided pursuant to § 36-11A-28. Within thirty days of receiving such form, the wholesale
distributor shall identify and state under oath to the board any changes or corrections to the
information that was provided pursuant to § 36-11A-28. Changes in, or corrections to, any
information in § 36-11A-28 shall be submitted to the board as required by such authority. The board
may suspend or revoke the license of a wholesale distributor if such authority determines that the
wholesale distributor no longer qualifies for the license issued under § 36-11A-28.
Source: SL 2007, ch 215, § 14.
36-11A-33 Continuing training of designated representative--Confidentiality of information.
Continuing training of designated representative--Confidentiality of information.
The designated representative identified pursuant to subdivision 36-11A-28(7) shall receive and
complete continuing training in applicable federal and state laws governing wholesale distribution
of prescription drugs.
The information provided under § 36-11A-28 may not be disclosed to any person or entity other
than a state board or agency, government board, or government agency, determined to be comparable
by the board, provided such licensing authority, government board, or agency needs such information
for licensing or monitoring purposes.
Source: SL 2007, ch 215, § 15.
36-11A-34 Returns or exchanges of prescription drugs.
Returns or exchanges of prescription drugs.
A wholesale distributor shall receive
prescription drug returns or exchanges from a pharmacy or chain pharmacy warehouse pursuant to
the terms and conditions of the agreement between the wholesale distributor and the pharmacy or
chain pharmacy warehouse. Returns of expired, damaged, recalled, or otherwise nonsaleable
pharmaceutical products shall be distributed by the receiving wholesale distributor only to either the
original manufacturer or a third party returns processor. The returns or exchanges of prescription
drugs, saleable or otherwise, including any redistribution by a receiving wholesaler, are not subject
to the pedigree requirement of § 36-11A-39, so long as they are exempt from pedigree under the
Federal Food and Drug Administration's currently applicable Prescription Drug Marketing Act
guidance. Wholesale distributors and pharmacies shall be held accountable for administering their
returns process and ensuring that the aspects of this operation are secure and do not permit the entry
of adulterated and counterfeit product.
Source: SL 2007, ch 215, § 16.
36-11A-35 Verification that entity to which prescription drugs are to be furnished is licensed.
Verification that entity to which prescription drugs are to be furnished is
A manufacturer or wholesale distributor shall furnish prescription drugs only to a person
or entity licensed by the appropriate board. Before furnishing prescription drugs to a person or entity
not known to the manufacturer or wholesale distributor, the manufacturer or wholesale distributor
shall affirmatively verify that the person or entity is legally authorized to receive the prescription
drugs by contacting the appropriate board.
Source: SL 2007, ch 215, § 17.
36-11A-36 Delivery of prescription drugs only to licensed premises--Exception.
Delivery of prescription drugs only to licensed premises--Exception.
drugs furnished by a manufacturer or wholesale distributor shall be delivered only to the premises
listed on the license. However, the manufacturer or wholesale distributor may furnish prescription
drugs to an authorized person or agent of that person at the premises of the manufacturer or
wholesale distributor if:
The identity and authorization of the recipient is properly established; and
This method of receipt is employed only to meet the immediate needs of a particular
patient of the authorized person.
SL 2007, ch 215, § 18.
36-11A-37 Receipt to be signed by authorized hospital pharmacy receiving personnel--Reporting of dis...
Receipt to be signed by authorized hospital pharmacy receiving personnel--Reporting of discrepancies.
Prescription drugs may be furnished to a hospital pharmacy receiving
area provided that a pharmacist or authorized receiving personnel signs, at the time of delivery, a
receipt showing the type and quantity of the prescription drug so received. Any discrepancy between
receipt and the type and quantity of the prescription drug actually received shall be reported to the
delivering manufacturer or wholesale distributor by the next business day after the delivery to the
pharmacy receiving area.
Source: SL 2007, ch 215, § 19.
36-11A-38 Accounts for purchase of prescription drugs.
Accounts for purchase of prescription drugs.
A manufacturer or wholesale
distributor may not accept payment for, or allow the use of, a person or entity's credit to establish an
account for the purchase of prescription drugs from any person other than the owner of record, the
chief executive officer, or the chief financial officer listed on the license of a person or entity legally
authorized to receive prescription drugs. Any account established for the purchase of prescription
drugs must bear the name of the licensee.
Source: SL 2007, ch 215, § 20.
36-11A-39 Pedigrees to be provided for prescription drugs that leave normal distribution channel.
Pedigrees to be provided for prescription drugs that leave normal distribution
Each person who is engaged in wholesale distribution of prescription drugs, including
repackagers, but excluding the original manufacturer of the finished form of the prescription drug
that leave, or have ever left, the normal distribution channel shall, before each wholesale distribution
of such drug, provide a pedigree to the person who receives such drug.
A retail pharmacy or chain pharmacy warehouse shall comply with the requirements of this
section only if the pharmacy or chain pharmacy warehouse engages in wholesale distribution of
prescription drugs, as defined in § 36-11A-26.
Source: SL 2007, ch 215, § 21.
36-11A-40 Electronic track and trace pedigree technology.
Electronic track and trace pedigree technology.
The board shall determine by July
1, 2009, a targeted implementation date for electronic track and trace pedigree technology. Such a
determination shall be based on consultation with manufacturers, distributors, and pharmacies
responsible for the sale and distribution of prescription drug products in this state. After consultation
with interested stakeholders and prior to implementation of the electronic pedigree, the board shall
determine that the technology is universally available across the entire prescription pharmaceutical
supply chain. The implementation date for the mandated electronic track and trace pedigree
technology shall be no sooner than July 1, 2010, and may be extended by the board in one year
increments if it appears the technology is not universally available across the entire prescription
pharmaceutical supply chain.
Source: SL 2007, ch 215, § 22.
36-11A-41 Verification of transactions listed on pedigree.
Verification of transactions listed on pedigree.
Each person who is engaged in
the wholesale distribution of a prescription drug including repackagers, but excluding the original
manufacturer of the finished form of the prescription drug, who is provided a pedigree for a
prescription drug and attempts to further distribute that prescription drug, shall affirmatively verify
before any distribution of a prescription drug occurs that each transaction listed on the pedigree has
Source: SL 2007, ch 215, § 23.
36-11A-42 Chain of distribution information to be included on pedigree.
Chain of distribution information to be included on pedigree.
The pedigree shall
include all necessary identifying information concerning each sale in the chain of distribution of the
product from the manufacturer, or the manufacturer's third party logistics provider, co-licensed
product partner, manufacturer's exclusive distributor, through acquisition and sale by any wholesale
distributor or repackager, until final sale to a pharmacy or other person dispensing or administering
the drug. At minimum, the necessary chain of distribution information shall include:
Name, address, telephone number, and if available, the e-mail address, of each owner of
the prescription drug, and each wholesale distributor of the prescription drug;
Name and address of each location from which the product was shipped, if different from
Transaction dates; and
Certification that each recipient has authenticated the pedigree.
SL 2007, ch 215, § 24.
36-11A-43 Additional information to be included on pedigree.
Additional information to be included on pedigree.
In addition to the
requirements of § 36-11A-42, the pedigree shall also include the following minimum requirements:
Name and national drug code number of the prescription drug;
Dosage form and strength of the prescription drug;
Size of the container;
Number of containers;
Lot number of the prescription drug; and
Name of the manufacturer of the finished dosage form.
SL 2007, ch 215, § 25.
36-11A-44 Pedigrees and electronic files to be maintained and available for inspection.
Pedigrees and electronic files to be maintained and available for inspection.
pedigree or electronic file shall be:
Maintained by the purchaser and the wholesale distributor for three years from the date
of sale or transfer; and
Available for inspection or use within two business days upon a request of an authorized
officer of the law.
SL 2007, ch 215, § 26.
36-11A-45 Cease and desist order for violation--Hearing.
Cease and desist order for violation--Hearing.
The board shall issue an order
requiring the appropriate person including any distributor or retailer of the drug to immediately cease
distribution of the drug within this state if the board finds that there is a reasonable probability that:
A wholesale distributor, other than a manufacturer, has:
Violated a provision of §§ 36-11A-20 to 36-11A-46, inclusive; or
Falsified a pedigree, or sold, distributed, transferred, manufactured, repackaged,
handled, or held a counterfeit prescription drug intended for human use;
The prescription drug at issue as a result of a violation in subdivision (1) could cause
serious, adverse health consequences or death; and
Other procedures would result in unreasonable delay.
An order under this section shall provide the person subject to the order with an opportunity for
an informal hearing, to be held not later than ten days after the date of the issuance of the order, on
the actions required by the order. If, after providing an opportunity for such a hearing, the board
determines that inadequate grounds exist to support the actions required by the order, the board shall
vacate the order.
Source: SL 2007, ch 215, § 27.
36-11A-46 Prohibited acts--Misdemeanor or felony.
Prohibited acts--Misdemeanor or felony.
It is unlawful for a person to perform
or cause the performance of or aid and abet any of the following acts in this state:
Failure to obtain a license in accordance with §§ 36-11A-20 to 36-11A-46, inclusive, or
operating without a valid license when a license is required by §§ 36-11A-20 to 36-11A-46, inclusive;
If the requirements of § 36-11A-34 are applicable and are not met, the purchasing or
otherwise receiving a prescription drug from a pharmacy;
If a state license is required pursuant to § 36-11A-35, the sale, distribution, or transfer of
a prescription drug to a person that is not authorized under the law of the jurisdiction in
which the person receives the prescription drug to receive the prescription drug;
Failure to deliver prescription drugs to specified premises, as required by § 36-11A-36;
Accepting payment or credit for the sale of prescription drugs in violation of § 36-11A-38;
Failure to maintain or provide pedigrees as required by §§ 36-11A-20 to 36-11A-46,
Failure to obtain, pass, or authenticate a pedigree, as required by §§ 36-11A-20 to 36-11A-46, inclusive;
Providing the state or any of its representatives or any federal official with false or
fraudulent records or making false or fraudulent statements regarding any matter within
the provisions of §§ 36-11A-20 to 36-11A-46, inclusive;
Obtaining or attempting to obtain a prescription drug by fraud, deceit, misrepresentation
or engaging in misrepresentation or fraud in the distribution of a prescription drug;
Except for the wholesale distribution by manufacturers of a prescription drug that has
been delivered into commerce pursuant to an application approved under federal law by
the Food and Drug Administration, the manufacture, repacking, sale, transfer, delivery,
holding, or offering for sale any prescription drug that is adulterated, misbranded,
counterfeit, suspected of being counterfeit, or has otherwise been rendered unfit for
Except for the wholesale distribution by manufacturers of a prescription drug that has
been delivered into commerce pursuant to an application approved under Federal law by
the Food and Drug Administration, the adulteration, misbranding, or counterfeiting of any
The receipt of any prescription drug that is adulterated, misbranded, stolen, obtained by
fraud or deceit, counterfeit, or suspected of being counterfeit, and the delivery or proffered
delivery of such drug for pay or otherwise; and
The alteration, mutilation, destruction, obliteration, or removal of the whole or any part
of the labeling of a prescription drug or the commission of any other act with respect to
a prescription drug that results in the prescription drug being misbranded.
Any person who violates this section is guilty of a Class 1 misdemeanor for the first conviction
and a Class 6 felony for any subsequent conviction.
Source: SL 2007, ch 215, § 28.
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