36-11A-4.2. Prior registration and inspection by FDA required for certain outsourcing facilities.
No outsourcing facility engaged in compounding of nonpatient specific sterile and nonsterile drugs may become licensed by the board without first obtaining a registration and inspection by the United States Food and Drug Administration, and paying the license fee set by the board in rules promulgated pursuant to chapter 1-26. The fee may not exceed two hundred dollars.
Source: SL 2017, ch 174, ยง8.
Structure 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-5 - Purchase of drug from other source restricted--Penalty.
Section 36-11A-8 - Application for license.
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-34 - Returns or exchanges of prescription drugs.
Section 36-11A-36 - Delivery of prescription drugs only to licensed premises--Exception.
Section 36-11A-38 - Accounts for purchase of prescription drugs.
Section 36-11A-44 - Retention of transaction files--Inspection.
Section 36-11A-45 - Cease and desist order for violation--Hearing.