NY Educ L § 6811-A (2021)
2021 New York Laws EDN - Education Title 8 - The Professions Article 137 - Pharmacy 6811-A - Certain Drugs to Be Clearly Marked or Labeled.

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