§ 6811-a. Certain drugs to be clearly marked or labeled.
1.Except as\notherwise authorized in the Federal Food, Drug and Cosmetic Act, no drug\nfor which a prescription is required by the provisions of the Federal\nFood, Drug and Cosmetic Act or by the commissioner of health may be\nmanufactured or commercially distributed within this state in tablet or\ncapsule form unless it has clearly marked or imprinted on each such\ntablet or capsule in conformance with the applicable plan required by\nsubdivision three of this section:\n (a) an individual symbol, number, company name, words, letters,\nmarking or National Drug Code (hereinafter referred to as N.
D.C.)\nnumber identifying the manufacturer or distributor of the drug; and\n (b) an N.
D.
C.number, symbol, number, letters, words or
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§ 6811-a. Certain drugs to be clearly marked or labeled. 1. Except as\notherwise authorized in the Federal Food, Drug and Cosmetic Act, no drug\nfor which a prescription is required by the provisions of the Federal\nFood, Drug and Cosmetic Act or by the commissioner of health may be\nmanufactured or commercially distributed within this state in tablet or\ncapsule form unless it has clearly marked or imprinted on each such\ntablet or capsule in conformance with the applicable plan required by\nsubdivision three of this section:\n (a) an individual symbol, number, company name, words, letters,\nmarking or National Drug Code (hereinafter referred to as N. D. C.)\nnumber identifying the manufacturer or distributor of the drug; and\n (b) an N. D. C. number, symbol, number, letters, words or marking\nidentifying such drug or combination of drugs.\n 2. Except as otherwise authorized in the Federal Food, Drug and\nCosmetic Act, no drug for which any prescription is required by the\nprovisions of the Federal Food, Drug and Cosmetic Act or by the\ncommissioner of health contained within a bottle, vial, carton or other\ncontainer, or in any way affixed or appended to or enclosed within a\npackage of any kind, and designed or intended for delivery in such\ncontainer or package to an ultimate consumer, shall be manufactured or\ndistributed within this state unless such container or package has\nclearly and permanently marked or imprinted upon it in conformance with\nthe applicable plan required by subdivision three of this section:\n (a) an individual symbol, N. D. C. number, company name, number,\nletters, words or marking identifying the manufacturer or distributor of\nthe drug;\n (b) an N. D. C. number, symbol, number, letters, words or marking\nidentifying such drug or combination of drugs; and\n (c) whenever the distributor of the prescription drug product does not\nalso manufacture the product the names and places of business of both\nshall appear on the label in words clearly distinguishing each.\n 3. (a) Each manufacturer and distributor shall prepare and submit to\nthe commissioner of health a proposed plan of the manufacturer or\ndistributor, as the case may be, to have its products comply with the\nmarking and labeling requirements of this section.\n (b) Such plan shall be in writing and shall give the respective dates\nby which the various products manufactured or distributed will each\ncontain the required mark or label. The plan shall state the reasons why\nthe projected date of compliance has been proposed and such other\ninformation deemed relevant or that the commissioner of health shall\nrequire.\n (c) The commissioner may either approve the plan as proposed or, after\nconsultation with the manufacturer or distributor, require an amendment\nor the commissioner may promulgate a plan for the manufacturer or\ndistributor. No plan or amendment to the plan shall be effective until\napproved or promulgated by the commissioner of health upon a finding by\nhim that the time limitations provided for therein are reasonable and\nwill best carry out the intendment of this section.\n 4. Each manufacturer and/or distributor shall publish and make\navailable, upon request, to the department of education, to each\nphysician, dentist, pharmacy, hospital or other institution wherein such\ndrugs may be used, a printed material which will identify each imprint\nused by the manufacturer or distributor. Updated materials shall be\nprovided as changes occur, upon the filing of an annual request. The\nprovisions of this subdivision shall be deemed to be complied with when\na prescription drug product is included in the Physician's Desk\nReference.\n 5. Every person, firm or corporation violating the provisions of this\nsection for any prescription drug product shall be guilty of an offense\npunishable by a fine of not less than twenty-five hundred dollars nor\nmore than ten thousand dollars. Any prescription drug product prepared\nor manufactured in violation of this section shall be contraband and\nsubject to seizure either by the state board of pharmacy or by any law\nenforcement officer of the state.\n 6. The provisions of this section shall not apply to any tablet or\ncapsule which contains a controlled substance as that term is defined by\narticle thirty-three of the public health law or which is prepared or\nmanufactured by a pharmacist duly licensed by the state which is made by\nhim for the purpose of retail sale from his principal place of business\nand not intended for resale.\n 7. The commissioner of health may exempt a particular tablet or\ncapsule from the requirements of this section, upon application by a\nmanufacturer, on the grounds that labeling such a tablet or capsule is\nunfeasible because of size or texture or other unique characteristics.\n 8. (a) As used in this section, the term "distributor" means the\nperson, firm, corporation or other entity which is not the actual\nmanufacturer of a prescription drug product but which distributes such\nproduct for resale under the label of such person, firm, corporation or\nentity.\n (b) For purposes of subdivision four "drug product" means the entire\nsupply of the finished dosage form of the drug.\n