Title 16, HEALTH

Sec. 1. As used in this chapter, "biological product" means: (1) a virus; (2) a therapeutic serum; (3) a toxin; (4) an antitoxin; (5) a vaccine; (6) blood; (7) a blood component; (8) a blood derivative; (9) an allergenic product; (10) a protein (except any chemically synthesized …

Sec. 2. As used in this chapter, "biosimilar" refers to a biological product that: (1) has been licensed as a biosimilar product under 41 U.S.C. 262(k) or has been approved based on an application filed under 21 U.S.C. 355(b)(2); and (2) is highly similar to the reference product…

Sec. 3. As used in this chapter, "interchangeable" means: (1) a determination by the federal Food and Drug Administration that a biosimilar product may be substituted for a reference biological product without the intervention of the health care provider that prescribed the biolo…

Sec. 4. A pharmacist may substitute for a prescribed biological product if the following conditions are met: (1) The substitute has been determined by the federal Food and Drug Administration to be interchangeable with the prescribed biological product. (2) The prescribing practi…

Sec. 5. (a) Except as provided in subsection (b), in order to ensure medical records are complete and accurate, a pharmacist shall, not later than ten (10) calendar days after dispensing a biologic product, record the name and manufacturer of the biologic product dispensed using:…

Sec. 6. (a) The pharmacy shall retain a record in accordance with IC 25-26-13-25(a) of the dispensed biological product. (b) The prescribing practitioner shall retain a record in accordance with IC 16-39-7-1 of the dispensed biological product. As added by P.L.96-2014, SEC.6.

Sec. 7. (a) The Indiana board of pharmacy shall maintain a link on the board's website to the current list of all biological products determined by the United States Food and Drug Administration to be interchangeable with a specific reference biological product. (b) The Indiana b…

Sec. 8. A written or electronic prescription for a biological product must comply with the requirements under IC 16-42-22-6. As added by P.L.96-2014, SEC.6.

Sec. 1. As used in this chapter, "agricultural labor camp" includes at least one (1) building or structure, tent, trailer, or vehicle, including the land, established, operated, or used as living quarters for at least five (5) adult seasonal or temporary workers engaged in agricu…

Sec. 10. (a) A person aggrieved by an order of the state department denying or revoking a permit to operate an agricultural labor camp may, in accordance with IC 4-21.5-5, petition the circuit or superior court for a review of the order asking that the order be modified or set as…

Sec. 11. To adequately place and care for workers and the workers' families housed in an agricultural labor camp, the state department shall serve notice of an action initiated under section 13 of this chapter to the following: (1) The county agricultural extension educator. (2) …

Sec. 12. The state department may designate an agent who may, on presentation of proper credentials, enter on private or public property to inspect for and investigate possible violations of this chapter or a rule adopted under this chapter. [Pre-1993 Recodification Citation: 13-…

Sec. 13. (a) The state department shall adopt rules under IC 4-22-2 that establish a schedule of civil penalties that may be levied in an action to enforce the provisions of the following: (1) This chapter. (2) The rules of the state department. (b) A penalty included in the sche…

Sec. 14. The owner or operator of an agricultural labor camp may under 29 U.S.C. 1821(c) impose a penalty on an agricultural laborer who knowingly or intentionally destroys or damages property on the premises of an agricultural labor camp. [Pre-1993 Recodification Citation: 13-1-…

Sec. 15. A construction permit issued by the state department for an agricultural labor camp under 410 IAC 6-9 is issued in accordance with IC 16-19-3.5. As added by P.L.49-2016, SEC.2.

Sec. 2. A person operating or maintaining an agricultural labor camp shall comply with this chapter and rules adopted under this chapter. [Pre-1993 Recodification Citation: 13-1-9-2.] As added by P.L.2-1993, SEC.24.

Sec. 3. (a) Except as provided in subsection (b), a person may not directly or indirectly operate an agricultural labor camp until the person has obtained from the state department a permit to operate the camp and unless the permit is in full force and effect and is posted and ke…

Sec. 4. (a) In addition to a permit issued under section 6 of this chapter, the state department may issue a permit that is limited to at least one (1) specific living unit of an agricultural labor camp. The state may issue more than one (1) permit under this section to a person …

Sec. 5. The state department may issue a permit under section 4 of this chapter only if: (1) all mobile homes used as shelters and equipped with an operable toilet, shower, lavatory, and hot and cold water under pressure, provide a minimum floor space of sixty (60) square feet fo…

Sec. 6. (a) An application to operate an agricultural labor camp must be made to the state department in writing on a form and under rules prescribed by the state department. (b) The state department shall issue a permit for the operation of an agricultural labor camp if the stat…

Sec. 7. The state department may, after reasonable notice and opportunity for a fair hearing in accordance with IC 4-21.5-3, revoke a permit authorizing the operation of an agricultural labor camp if the state department finds that the holder of the permit has failed to comply wi…

Note: This version of section effective until 7-1-2027. See also following version of this section, effective 7-1-2027. Sec. 8. (a) Except as provided in subsection (b), the state department shall adopt rules under IC 4-22-2 necessary to protect the health, safety, and welfare of…

Sec. 9. (a) The state department may initiate an action under IC 4-21.5-3-6 or IC 4-21.5-3-8 to enforce this chapter and rules adopted under this chapter. (b) The state department and the state department's authorized representatives may enter and inspect agricultural labor camps…

Sec. 1. (a) This chapter does not affect IC 5-10-8-15, IC 12-15-5-9.2, IC 27-8-25, or IC 27-13-7-20.2. (b) This chapter does not require a manufacturer to make available any investigational drug, biological product, or device. As added by P.L.2-2015, SEC.3.

Sec. 2. As used in this chapter, "investigational drug, biological product, or device" means an investigational or experimental: (1) drug; (2) biological product; or (3) medical device; that has successfully completed Phase I of a federal Food and Drug Administration approved cli…

Sec. 3. As used in this chapter, "qualified patient" means a patient who meets the requirements under IC 25-22.5-1-2.1(a). As added by P.L.2-2015, SEC.3.

Sec. 4. (a) A manufacturer of an investigational drug, biological product, or device may make available the investigational drug, biological product, or device to a qualified patient. (b) A manufacturer may do any of the following: (1) Provide an investigational drug, biological …

Sec. 5. This chapter does not create a cause of action against a manufacturer of an investigational drug, biological product, or device for any harm to a qualified patient resulting from use of an investigational drug, biological product, or device. As added by P.L.2-2015, SEC.3.

Sec. 1. This chapter recognizes mobile homes, manufactured homes, and industrialized residential structures as suitable and necessary dwelling units in Indiana. The state department may do the following: (1) Require reasonable standards of health, sanitation, and safety in using …

Sec. 10. (a) A mobile home community shall provide a water supply through the use of a public water system if the water supply is reasonably available within a reasonable distance from the mobile home community. A mobile home community is not required to use a public water system…

Sec. 11. (a) A mobile home community shall dispose of sewage through the use of a public sewerage system if the sewerage system is available within a reasonable distance from the mobile home community. If a public sewerage system is not available, sewage may be disposed of in acc…

Sec. 12. Suitable garbage containers or a garbage disposal system and trash containers shall be made available in a sanitary manner to each occupied mobile home, manufactured home, and industrialized residential structure. The garbage and trash of the mobile home community must b…

Sec. 15. Streets must be at least ten (10) feet wide and sufficiently wide to prevent vehicular and pedestrian traffic problems. Adequate area must be provided for the parking of vehicles. All roads in a mobile home community shall be maintained to be dust proof. Each mobile home…

Sec. 16. (a) This section does not apply to feral cats that are caught and released as part of a spay and neuter program designed to reduce the number of feral cats in the area. (b) Domestic animals and house pets may not be permitted to run at large or commit a nuisance within t…

Sec. 16.6. (a) Each year during National Fire Prevention Week, the operator of a mobile home community is encouraged to provide a written reminder to the owners of all manufactured homes and industrialized residential structures in the mobile home community to replace the batteri…

Sec. 17. Every part of a mobile home community must be lighted at night. [Pre-1993 Recodification Citation: 13-1-7-21.] As added by P.L.2-1993, SEC.24. Amended by P.L.142-1995, SEC.26; P.L.87-2005, SEC.16.

Sec. 18. A mobile home community may not be operated without obtaining a license from the state department. [Pre-1993 Recodification Citation: 13-1-7-22.] As added by P.L.2-1993, SEC.24. Amended by P.L.87-2005, SEC.17.

Sec. 19. A license to operate a mobile home community shall be issued for four (4) years and expires at midnight on December 31. [Pre-1993 Recodification Citation: 13-1-7-23.] As added by P.L.2-1993, SEC.24. Amended by P.L.87-2005, SEC.18.

Sec. 2.1. (a) As used in this chapter, "industrialized residential structure" means a structure that is both an industrialized building system (as defined in IC 22-12-1-14) and a one (1) or two (2) family private residence. (b) The term does not include either of the following: (…

Sec. 20. (a) An application for a license to operate a mobile home community must be made to the state department on a form prescribed and furnished by the state department, only after plans for the mobile home community have been approved. (b) If an operator does not apply for t…

Sec. 21. The state department may license a temporary mobile home community for a period of six (6) months and waive the requirements of this chapter if: (1) the failure to comply with this chapter is: (A) for a temporary period of time; and (B) required by public convenience; an…

Sec. 22. (a) The construction of a new mobile home community or alteration of an existing mobile home community shall be made only after plans for the proposed construction or alteration have been forwarded to and approved by the state department in accordance with IC 16-19-3.5. …

Sec. 23. The state department or the environmental commissioner shall, not more than ninety (90) days after filing, approve plans filed under section 22 of this chapter that comply with this chapter and rules adopted under this chapter. [Pre-1993 Recodification Citation: 13-1-7-2…

Sec. 24. (a) An inspection fee must be submitted to the state department with each license application. The fee is two hundred dollars ($200) for a total of not more than fifty (50) mobile home, manufactured home, and industrialized residential structure sites and one hundred fif…

Sec. 25. (a) The state department shall adopt a schedule of civil penalties that may be levied in an action to enforce the following: (1) This chapter. (2) The rules of the state department. (3) The rules adopted under this chapter by the environmental rules board. (b) A penalty …

Sec. 26. (a) The state department shall provide a written notice to a mobile home community operator of the following: (1) The revocation of the operator's license. (2) The denial of the operator's application for a license. (3) The denial of the approval of the construction or a…