State Codes and Statutes

Statutes > North-carolina > Chapter_106 > GS_106-133

§ 106‑133.  Drugsdeemed to be adulterated.

A drug or device shall be deemed to be adulterated:

(1)        a.         If it consists in whole or inpart of any filthy, putrid or decomposed substance; or

b.         If it has been produced, prepared, packed, or held underinsanitary conditions whereby it may have been contaminated with filth, orwhereby it may have been rendered injurious to health; or

c.         If it is a drug and its container is composed, in whole orin part, of any poisonous or deleterious substance which may render thecontents injurious to health; or

d.         If

1.         It is a drug and it bears or contains, for purposes ofcoloring only, a color additive which is unsafe within the meaning of G.S. 106‑132,or

2.         If it is a color additive, the intended use of which in oron drugs is for purposes of coloring only, and is unsafe within the meaning ofG.S. 106‑132;

e.         If it is a drug and the methods used in, or the facilitiesor controls used for, its manufacture, processing, packing, or holding do notconform to or are not operated or administered in conformity with current goodmanufacturing practice to assure that such drug meets the requirements of thisArticle as to safety and has the identity and strength, and meets the qualityand purity characteristics, which it purports or is represented to possess.

(2)        If it purports to be or is represented as a drug the name ofwhich is recognized in an official compendium, and its strength differs from,or its quality or purity falls below, the standard set forth in suchcompendium. Such determination as to strength, quality, or purity shall be madein accordance with the tests or methods of assay set forth in such compendium,or in the absence of or inadequacy of such tests or methods of assay, those soprescribed under authority of the federal act. No drug defined in an officialcompendium shall be deemed to be adulterated under this subdivision because itdiffers from the standard of strength, quality, or purity therefor set forth insuch compendium, if its difference in strength, quality, or purity from suchstandard is plainly stated on its label. Whenever a drug is recognized in boththe United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the UnitedStates it shall be subject to the requirements of the United States Pharmacopoeiaunless it is labeled and offered for sale as a  homeopathic drug, in which caseit shall be subject to the provisions of the Homeopathic Pharmacopoeia of theUnited States and not to those of the United States Pharmacopoeia.

(3)        If it is not subject to the provisions of subdivision (2) ofthis section and its strength differs from, or its purity or quality fallsbelow, that which it purports or is represented to possess.

(4)        If it is a drug and any substance has been

a.         Mixed or packed therewith so as to reduce its quality orstrength; or

b.         Substituted wholly or in part therefor. (1939, c. 320, s.  14; 1975, c. 614, ss. 22‑24.)

State Codes and Statutes

Statutes > North-carolina > Chapter_106 > GS_106-133

§ 106‑133.  Drugsdeemed to be adulterated.

A drug or device shall be deemed to be adulterated:

(1)        a.         If it consists in whole or inpart of any filthy, putrid or decomposed substance; or

b.         If it has been produced, prepared, packed, or held underinsanitary conditions whereby it may have been contaminated with filth, orwhereby it may have been rendered injurious to health; or

c.         If it is a drug and its container is composed, in whole orin part, of any poisonous or deleterious substance which may render thecontents injurious to health; or

d.         If

1.         It is a drug and it bears or contains, for purposes ofcoloring only, a color additive which is unsafe within the meaning of G.S. 106‑132,or

2.         If it is a color additive, the intended use of which in oron drugs is for purposes of coloring only, and is unsafe within the meaning ofG.S. 106‑132;

e.         If it is a drug and the methods used in, or the facilitiesor controls used for, its manufacture, processing, packing, or holding do notconform to or are not operated or administered in conformity with current goodmanufacturing practice to assure that such drug meets the requirements of thisArticle as to safety and has the identity and strength, and meets the qualityand purity characteristics, which it purports or is represented to possess.

(2)        If it purports to be or is represented as a drug the name ofwhich is recognized in an official compendium, and its strength differs from,or its quality or purity falls below, the standard set forth in suchcompendium. Such determination as to strength, quality, or purity shall be madein accordance with the tests or methods of assay set forth in such compendium,or in the absence of or inadequacy of such tests or methods of assay, those soprescribed under authority of the federal act. No drug defined in an officialcompendium shall be deemed to be adulterated under this subdivision because itdiffers from the standard of strength, quality, or purity therefor set forth insuch compendium, if its difference in strength, quality, or purity from suchstandard is plainly stated on its label. Whenever a drug is recognized in boththe United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the UnitedStates it shall be subject to the requirements of the United States Pharmacopoeiaunless it is labeled and offered for sale as a  homeopathic drug, in which caseit shall be subject to the provisions of the Homeopathic Pharmacopoeia of theUnited States and not to those of the United States Pharmacopoeia.

(3)        If it is not subject to the provisions of subdivision (2) ofthis section and its strength differs from, or its purity or quality fallsbelow, that which it purports or is represented to possess.

(4)        If it is a drug and any substance has been

a.         Mixed or packed therewith so as to reduce its quality orstrength; or

b.         Substituted wholly or in part therefor. (1939, c. 320, s.  14; 1975, c. 614, ss. 22‑24.)


State Codes and Statutes

State Codes and Statutes

Statutes > North-carolina > Chapter_106 > GS_106-133

§ 106‑133.  Drugsdeemed to be adulterated.

A drug or device shall be deemed to be adulterated:

(1)        a.         If it consists in whole or inpart of any filthy, putrid or decomposed substance; or

b.         If it has been produced, prepared, packed, or held underinsanitary conditions whereby it may have been contaminated with filth, orwhereby it may have been rendered injurious to health; or

c.         If it is a drug and its container is composed, in whole orin part, of any poisonous or deleterious substance which may render thecontents injurious to health; or

d.         If

1.         It is a drug and it bears or contains, for purposes ofcoloring only, a color additive which is unsafe within the meaning of G.S. 106‑132,or

2.         If it is a color additive, the intended use of which in oron drugs is for purposes of coloring only, and is unsafe within the meaning ofG.S. 106‑132;

e.         If it is a drug and the methods used in, or the facilitiesor controls used for, its manufacture, processing, packing, or holding do notconform to or are not operated or administered in conformity with current goodmanufacturing practice to assure that such drug meets the requirements of thisArticle as to safety and has the identity and strength, and meets the qualityand purity characteristics, which it purports or is represented to possess.

(2)        If it purports to be or is represented as a drug the name ofwhich is recognized in an official compendium, and its strength differs from,or its quality or purity falls below, the standard set forth in suchcompendium. Such determination as to strength, quality, or purity shall be madein accordance with the tests or methods of assay set forth in such compendium,or in the absence of or inadequacy of such tests or methods of assay, those soprescribed under authority of the federal act. No drug defined in an officialcompendium shall be deemed to be adulterated under this subdivision because itdiffers from the standard of strength, quality, or purity therefor set forth insuch compendium, if its difference in strength, quality, or purity from suchstandard is plainly stated on its label. Whenever a drug is recognized in boththe United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the UnitedStates it shall be subject to the requirements of the United States Pharmacopoeiaunless it is labeled and offered for sale as a  homeopathic drug, in which caseit shall be subject to the provisions of the Homeopathic Pharmacopoeia of theUnited States and not to those of the United States Pharmacopoeia.

(3)        If it is not subject to the provisions of subdivision (2) ofthis section and its strength differs from, or its purity or quality fallsbelow, that which it purports or is represented to possess.

(4)        If it is a drug and any substance has been

a.         Mixed or packed therewith so as to reduce its quality orstrength; or

b.         Substituted wholly or in part therefor. (1939, c. 320, s.  14; 1975, c. 614, ss. 22‑24.)