2006 New York Code - Certain Drugs To Be Clearly Marked Or Labeled.

 
    § 6811-a. Certain  drugs  to be clearly marked or labeled.  1. 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. 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.