§ 106‑140.1. Registration of producers of prescription drugs and devices.
(a) On or before December 31 of each year, every person doingbusiness in North Carolina and operating as a wholesaler, manufacturer, orrepackager, as those terms are defined in subsection (j) of this section, shallregister with the Commissioner his name and business location(s) in NorthCarolina. If said person has no business locations in North Carolina, he shallregister his name and location of his corporate offices.
(b) Every person, upon first operating as a wholesaler,manufacturer or repackager in North Carolina shall immediately register withthe Commissioner his name, place of business, and such establishment. If saidperson has no business locations in North Carolina, he shall register his nameand location of his corporate offices.
(c) Every person duly registered in accordance with subsections(a) and (b) of this section shall register with the Commissioner any additionalestablishment that he owns or operates in the State of North Carolina prior todoing business as a manufacturer, wholesaler or repackager.
(d) The Commissioner may assign a registration number to anyperson or any establishment registered in accordance with this section.
(e) The Commissioner shall make available for inspection to anyperson so requesting any registration filed pursuant to this section.
(f) The following classes of people are exempt from theregistration requirements of this section:
(1) Pharmacists as defined in G.S. 90‑85.3(q) holding a validpermit as defined in G.S. 90‑85.3(m);
(2) Practitioners licensed or registered by law to prescribe oradminister drugs and who manufacture, prepare, compound, or process drugs ordevices solely for use in the course of their professional practice.
(3) Persons who manufacture, prepare, compound, or process drugssolely for use in research, teaching, or chemical analysis and not for sale.
(4) Other classes of persons the Commissioner may by rule exemptfrom the application of this section upon a finding that registration by theseclasses of persons in accordance with this section is not necessary for theprotection of the public health.
(5) Wholesale distributors of prescription drugs licensed underG.S. 106‑145.3.
(g) Every establishment in the State of North Carolinaregistered with the Commissioner pursuant to this section shall be subject toinspection pursuant to G.S. 106‑140.
(h) The Commissioner shall adopt rules to implement theregistration requirements of this section. These rules may provide for anannual registration fee of up to five hundred dollars ($500.00) for companiesoperating as manufacturers, wholesalers, or repackagers. The Department ofAgriculture and Consumer Services shall use these funds for the implementationof the North Carolina Food, Drug and Cosmetic Act.
(i) For the purposes of this act, name means the name of thepartnership if a partnership and the name of the corporation if a corporation.
(j) As used in this section:
(1) The term "manufacturer" means a person whoprepares, derives, or produces a prescription drug. Pharmacists arespecifically excluded from this definition if they are acting in the course oftheir professional practice as defined in Chapter 90 and rules adopted pursuantto it.
(2) The term "prescription drug" means a drug thatunder federal law is required, prior to being dispensed or delivered, to belabeled with the following statement: "Caution: Federal law prohibitsdispensing without a prescription."
(3) The term "repackager" means a person who repacks,relabels, or manipulates a prescription drug which was in a unit packaged andsealed by a manufacturer. Pharmacists are specifically exempted from thisdefinition if they are acting in the course of their professional practice asdefined in Chapter 90 and rules adopted pursuant to it.
(4) The term "wholesaler" means a person acting as ajobber, wholesale merchant, salvager, or broker, or agent thereof, who sells ordistributes for resale a prescription drug. Pharmacists are specificallyexempted from this definition if they are acting in the course of theirprofessional practice as defined in Chapter 90 and rules adopted pursuant toit. (1987, c. 737, s. 2; 1989,c. 226, s. 2; 1989 (Reg. Sess., 1990), c. 1024, s. 20; 1991, c. 699, ss. 3, 4;1997‑261, s. 109.)
§ 106‑140.1. Registration of producers of prescription drugs and devices.
(a) On or before December 31 of each year, every person doingbusiness in North Carolina and operating as a wholesaler, manufacturer, orrepackager, as those terms are defined in subsection (j) of this section, shallregister with the Commissioner his name and business location(s) in NorthCarolina. If said person has no business locations in North Carolina, he shallregister his name and location of his corporate offices.
(b) Every person, upon first operating as a wholesaler,manufacturer or repackager in North Carolina shall immediately register withthe Commissioner his name, place of business, and such establishment. If saidperson has no business locations in North Carolina, he shall register his nameand location of his corporate offices.
(c) Every person duly registered in accordance with subsections(a) and (b) of this section shall register with the Commissioner any additionalestablishment that he owns or operates in the State of North Carolina prior todoing business as a manufacturer, wholesaler or repackager.
(d) The Commissioner may assign a registration number to anyperson or any establishment registered in accordance with this section.
(e) The Commissioner shall make available for inspection to anyperson so requesting any registration filed pursuant to this section.
(f) The following classes of people are exempt from theregistration requirements of this section:
(1) Pharmacists as defined in G.S. 90‑85.3(q) holding a validpermit as defined in G.S. 90‑85.3(m);
(2) Practitioners licensed or registered by law to prescribe oradminister drugs and who manufacture, prepare, compound, or process drugs ordevices solely for use in the course of their professional practice.
(3) Persons who manufacture, prepare, compound, or process drugssolely for use in research, teaching, or chemical analysis and not for sale.
(4) Other classes of persons the Commissioner may by rule exemptfrom the application of this section upon a finding that registration by theseclasses of persons in accordance with this section is not necessary for theprotection of the public health.
(5) Wholesale distributors of prescription drugs licensed underG.S. 106‑145.3.
(g) Every establishment in the State of North Carolinaregistered with the Commissioner pursuant to this section shall be subject toinspection pursuant to G.S. 106‑140.
(h) The Commissioner shall adopt rules to implement theregistration requirements of this section. These rules may provide for anannual registration fee of up to five hundred dollars ($500.00) for companiesoperating as manufacturers, wholesalers, or repackagers. The Department ofAgriculture and Consumer Services shall use these funds for the implementationof the North Carolina Food, Drug and Cosmetic Act.
(i) For the purposes of this act, name means the name of thepartnership if a partnership and the name of the corporation if a corporation.
(j) As used in this section:
(1) The term "manufacturer" means a person whoprepares, derives, or produces a prescription drug. Pharmacists arespecifically excluded from this definition if they are acting in the course oftheir professional practice as defined in Chapter 90 and rules adopted pursuantto it.
(2) The term "prescription drug" means a drug thatunder federal law is required, prior to being dispensed or delivered, to belabeled with the following statement: "Caution: Federal law prohibitsdispensing without a prescription."
(3) The term "repackager" means a person who repacks,relabels, or manipulates a prescription drug which was in a unit packaged andsealed by a manufacturer. Pharmacists are specifically exempted from thisdefinition if they are acting in the course of their professional practice asdefined in Chapter 90 and rules adopted pursuant to it.
(4) The term "wholesaler" means a person acting as ajobber, wholesale merchant, salvager, or broker, or agent thereof, who sells ordistributes for resale a prescription drug. Pharmacists are specificallyexempted from this definition if they are acting in the course of theirprofessional practice as defined in Chapter 90 and rules adopted pursuant toit. (1987, c. 737, s. 2; 1989,c. 226, s. 2; 1989 (Reg. Sess., 1990), c. 1024, s. 20; 1991, c. 699, ss. 3, 4;1997‑261, s. 109.)
§ 106‑140.1. Registration of producers of prescription drugs and devices.
(a) On or before December 31 of each year, every person doingbusiness in North Carolina and operating as a wholesaler, manufacturer, orrepackager, as those terms are defined in subsection (j) of this section, shallregister with the Commissioner his name and business location(s) in NorthCarolina. If said person has no business locations in North Carolina, he shallregister his name and location of his corporate offices.
(b) Every person, upon first operating as a wholesaler,manufacturer or repackager in North Carolina shall immediately register withthe Commissioner his name, place of business, and such establishment. If saidperson has no business locations in North Carolina, he shall register his nameand location of his corporate offices.
(c) Every person duly registered in accordance with subsections(a) and (b) of this section shall register with the Commissioner any additionalestablishment that he owns or operates in the State of North Carolina prior todoing business as a manufacturer, wholesaler or repackager.
(d) The Commissioner may assign a registration number to anyperson or any establishment registered in accordance with this section.
(e) The Commissioner shall make available for inspection to anyperson so requesting any registration filed pursuant to this section.
(f) The following classes of people are exempt from theregistration requirements of this section:
(1) Pharmacists as defined in G.S. 90‑85.3(q) holding a validpermit as defined in G.S. 90‑85.3(m);
(2) Practitioners licensed or registered by law to prescribe oradminister drugs and who manufacture, prepare, compound, or process drugs ordevices solely for use in the course of their professional practice.
(3) Persons who manufacture, prepare, compound, or process drugssolely for use in research, teaching, or chemical analysis and not for sale.
(4) Other classes of persons the Commissioner may by rule exemptfrom the application of this section upon a finding that registration by theseclasses of persons in accordance with this section is not necessary for theprotection of the public health.
(5) Wholesale distributors of prescription drugs licensed underG.S. 106‑145.3.
(g) Every establishment in the State of North Carolinaregistered with the Commissioner pursuant to this section shall be subject toinspection pursuant to G.S. 106‑140.
(h) The Commissioner shall adopt rules to implement theregistration requirements of this section. These rules may provide for anannual registration fee of up to five hundred dollars ($500.00) for companiesoperating as manufacturers, wholesalers, or repackagers. The Department ofAgriculture and Consumer Services shall use these funds for the implementationof the North Carolina Food, Drug and Cosmetic Act.
(i) For the purposes of this act, name means the name of thepartnership if a partnership and the name of the corporation if a corporation.
(j) As used in this section:
(1) The term "manufacturer" means a person whoprepares, derives, or produces a prescription drug. Pharmacists arespecifically excluded from this definition if they are acting in the course oftheir professional practice as defined in Chapter 90 and rules adopted pursuantto it.
(2) The term "prescription drug" means a drug thatunder federal law is required, prior to being dispensed or delivered, to belabeled with the following statement: "Caution: Federal law prohibitsdispensing without a prescription."
(3) The term "repackager" means a person who repacks,relabels, or manipulates a prescription drug which was in a unit packaged andsealed by a manufacturer. Pharmacists are specifically exempted from thisdefinition if they are acting in the course of their professional practice asdefined in Chapter 90 and rules adopted pursuant to it.
(4) The term "wholesaler" means a person acting as ajobber, wholesale merchant, salvager, or broker, or agent thereof, who sells ordistributes for resale a prescription drug. Pharmacists are specificallyexempted from this definition if they are acting in the course of theirprofessional practice as defined in Chapter 90 and rules adopted pursuant toit. (1987, c. 737, s. 2; 1989,c. 226, s. 2; 1989 (Reg. Sess., 1990), c. 1024, s. 20; 1991, c. 699, ss. 3, 4;1997‑261, s. 109.)
