2023 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.