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This entry was published on 2014-09-22
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SECTION 6811-A
Certain drugs to be clearly marked or labeled
Education (EDN) CHAPTER 16, TITLE 8, ARTICLE 137
§ 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.