South Dakota Codified Laws
Chapter 11A - Wholesale Drug Distributors
Section 36-11A-29 - Inspection of facility--Qualifications of designated representative.

36-11A-29. 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:
(1)Conducts a physical inspection of the facility at the address provided by the applicant as required in subdivision 36-11A-28(1); and
(2)Determines that the designated representative meets the following qualifications:
(a)Is at least twenty-one years of age;
(b)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;
(c)Is employed by the applicant full time in a managerial level position;
(d)Is actively involved in and aware of the actual daily operation of the wholesale distributor;
(e)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;
(f)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;
(g)Does not have any convictions under any federal, state, or local laws relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and
(h)Does not have any felony convictions under federal or state laws.

Source: SL 2007, ch 215, ยง11.

Structure South Dakota Codified Laws

South Dakota Codified Laws

Title 36 - Professions and Occupations

Chapter 11A - Wholesale Drug Distributors

Section 36-11A-1 - Definitions.

Section 36-11A-1.1 - Trading partner defined.

Section 36-11A-1.2 - Transaction defined.

Section 36-11A-1.3 - Transaction information defined.

Section 36-11A-1.4 - Transaction statement defined.

Section 36-11A-2 - Distribution defined.

Section 36-11A-4 - Pharmacy distributor defined.

Section 36-11A-4.1 - License required for wholesale distributors, outsourcing facilities, and third-party logistics providers.

Section 36-11A-4.2 - Prior registration and inspection by FDA required for certain outsourcing facilities.

Section 36-11A-5 - Purchase of drug from other source restricted--Penalty.

Section 36-11A-6 - Drug sample or drug coupon--Sale, purchase, trade or counterfeit prohibited--Distribution restricted--Penalty.

Section 36-11A-7 - Wholesale distribution without license prohibited--License unnecessary for agent or employee of licensed distributor--Violation as felony.

Section 36-11A-8 - Application for license.

Section 36-11A-9 - Separate license required for each facility owned or operated by same business entity.

Section 36-11A-10 - Temporary licenses.

Section 36-11A-11 - Out-of-state distributor--License--Application--Violation as felony.

Section 36-11A-12 - Approval or denial of application or renewal--Appeal.

Section 36-11A-13 - Expiration and renewal of license.

Section 36-11A-14 - Promulgation of rules.

Section 36-11A-16 - Inspection--Exemption--Penalty.

Section 36-11A-17 - Records--Availability.

Section 36-11A-18 - Limitations on state board of pharmacy.

Section 36-11A-19 - Complaints--Procedure.

Section 36-11A-20 - Authorized distributor of record defined.

Section 36-11A-21 - Drop shipment defined.

Section 36-11A-22 - Manufacturer's exclusive distributor defined.

Section 36-11A-23 - Normal distribution channel defined.

Section 36-11A-24 - Third party logistics provider defined.

Section 36-11A-25 - Wholesale distributor defined.

Section 36-11A-27 - Wholesale distributor license required--Exemptions.

Section 36-11A-28 - Information to be provided by applicants.

Section 36-11A-29 - Inspection of facility--Qualifications of designated representative.

Section 36-11A-30 - Criminal record check.

Section 36-11A-31 - Bond or other security required--Purpose--Exemption--License required for each facility.

Section 36-11A-32 - Changes or corrections to required information--Suspension or revocation of license.

Section 36-11A-33 - Continuing training of designated representative--Confidentiality of information.

Section 36-11A-34 - Returns or exchanges of prescription drugs.

Section 36-11A-35 - Verification that entity to which prescription drugs are to be furnished is licensed.

Section 36-11A-36 - Delivery of prescription drugs only to licensed premises--Exception.

Section 36-11A-37 - Receipt to be signed by authorized hospital pharmacy receiving personnel--Reporting of discrepancies.

Section 36-11A-38 - Accounts for purchase of prescription drugs.

Section 36-11A-41 - Confirmation of receipt of transaction information, transaction history, and transaction statement.

Section 36-11A-44 - Retention of transaction files--Inspection.

Section 36-11A-45 - Cease and desist order for violation--Hearing.

Section 36-11A-46 - Prohibited acts--Misdemeanor or felony.