La. Admin. Code tit. 46 § XCI-105

Current through Register Vol. 50, No. 11, November 20, 2024

Section XCI-105 - Exemptions

A. Distribution does not include:

1. intra -company distribution to licensed drug or device distributors physically located in Louisiana;

2. the distribution of a drug or device or an offer to distribute a drug or device by a charitable organization described in section 501(c)(3) of the Internal Revenue Code of 1954 to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

3. the distribution of a drug or device or an offer to distribute a drug or device among hospitals or other health care entities that are under common ownership;

4. the distribution of a drug or device or an offer to distribute a drug or device for emergency medical reasons including transfers of drugs or devices by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage that arises from delays in or interruptions of regular distribution schedules or a public health emergency declaration;

5. the dispensing of a drug or device pursuant to a prescription;

6. the distribution of drug or device samples by manufacturers' representatives or distributors' representatives;

7. the distribution of blood and blood components intended for transfusion; or

8. the distribution of legend drugs by retail pharmacies to licensed practitioners for office use where the annual dollar volume of legend drugs sold to licensed practitioners does not exceed five percent of the dollar volume of that retail pharmacy's annual legend drug sales.

9. the distribution of devices by manufacturers sales representatives during transportation to customers;

10. the distribution of a software utilized in a non-emergency, delayed patient monitoring system to be used in remote monitoring not intended to provide real time integrated data from a continuous or long-time, non-invasive patient monitoring device, and that has been previously approved by the appropriate federal agency; this exemption shall not be deemed to prohibit regulation in accordance with quarantine statutes.

B. Wholesale distribution does not include:

1. intra-company distribution between members of an affiliate or within a manufacturer;

2. the distribution of or offer to distribute among hospitals or other health care entities which are under common control;

3. the distribution or offer to distribute for emergency medical reasons including a public health emergency declaration, except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;

4. the dispensing pursuant to a prescription;

5. the distribution of minimal quantities by a licensed retail pharmacy to a licensed practitioner for office use;

6. the distribution or offer to distribute by charitable organizations to nonprofit affiliates of the organization;

7. the purchase or other acquisition by a retail dispenser, hospital, or other health care entity for use by such retail dispenser, hospital, or other health care entity;

8. the distribution by the manufacturer;

9. the receipt or transfer by an authorized third-party logistics provider provided that such third-party logistics provider does not take ownership;

10. a common carrier that transports a drug product, provided that the common carrier does not take ownership;

11. the distribution or offer to distribute by an authorized repackager that has taken ownership or possession and repacks;

12. salable drug product returns when conducted by a retail dispenser;

13. the distribution of a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user, if:

a. the kit is assembled in an establishment registered with FDA as a device manufacturer;

b. the kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of 1970 and any amendments to;

c. the kit includes a product, the person that manufacturers the kit:

i. purchased directly from the manufacturer or from a wholesale distributor that purchased directly from the manufacturer, and

ii. does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and

d. kits that include a product and the product is:

i. an intravenous solution intended for replenishment of fluids and electrolytes;

ii. intended to maintain the equilibrium of water and minerals in the body;

iii. intended for irrigation or reconstitution;

iv. an anesthetic;

v. an anticoagulant;

vi. a vasopressor, or

vii. a sympathomimetic;

14. the distribution of an intravenous drug that by its formulation is intended for the replenishment of fluids and electrolytes or calories;

15. the distribution of an intravenous drug used to maintain the equilibrium of water and minerals in the body;

16. the distribution of a drug intended for irrigation, or sterile water, whether intended for such purposes or for injection;

17. the distribution of medical gas;

18. facilitating the distribution by providing solely administrative services including processing orders and payments; or

19. the transfer by a hospital or other health care entity, or by a wholesale distributor or manufacturer operating at the direction of the hospital, or other health care entity, to a repackager who is registered for the purpose of repackaging for use by the hospital, or other heath care entity, and other health care entities that are under common control, if ownership of the drug remains with the hospital or other health care entity at all times.

La. Admin. Code tit. 46, § XCI-105

Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 35:1537 (August 2009), amended LR 36:321 (February 2010), LR 36:2560 (November 2010), LR 37:899 (March 2011), Amended by the Department of Health, Board of Drug and Device Distributors LR 422182 (12/1/2016).

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.