S.Amdt. 3377

SA 3377. Mr. KING submitted an amendment intended to be proposed by
him to the bill S. 524, to authorize the Attorney General to award
grants to address the national epidemics of prescription opioid abuse
and heroin use; which was ordered to lie on the table; as follows:

At the end, add the following:

TITLE VIII--PHARMACEUTICAL STEWARDSHIP ACT

SEC. 801. SHORT TITLE.

This title may be cited as the ``Pharmaceutical Stewardship
Act of 2016''.

SEC. 802. NATIONAL PHARMACEUTICAL STEWARDSHIP PROGRAMS.

(a) Definitions.--In this section:
(1) The term ``board of directors'' means the board of
directors of the organization.
(2) The term ``producer'', with respect to a covered drug,
means the holder of an approved application for the covered
drug under subsection (b) or (j) of section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).
(3) The term ``certified national pharmaceutical
stewardship program'' means a national pharmaceutical
stewardship program with a certification in effect under
subsection (g) or (h).
(4) The term ``controlled substance'' means a controlled
substance (as such term is defined in section 102 of the
Controlled Substances Act (21 U.S.C. 802)) in schedule II,
III, IV, or V under section 202 of such Act (21 U.S.C. 812).
(5) The term ``covered drug'' means a drug (as such term is
defined in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321)) that is marketed in the United
States other than--
(A) a drug for which a take-back program is in effect
pursuant to a risk evaluation and mitigation strategy under
section 505-1 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355-1);
(B) a vitamin or dietary supplement (as such term is
defined in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321));
(C) an herbal-based remedy or homeopathic drug, product, or
remedy;
(D) a soap (with or without germicidal agents), laundry
detergent, bleach, household cleaning product, shampoo,
sunscreen, toothpaste, lip balm, antiperspirant, or other
product that is regulated under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) exclusively as a
cosmetic;
(E) a biological product (as defined in section 351 of the
Public Health Service Act (42 U.S.C. 262)); or
(F) a pesticide (as defined in section 2 of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136))
that is contained in a collar, powder, shampoo, topical
application, or other system for delivery or application to a
pet.
(6) The term ``organization'' means the National
Pharmaceutical Stewardship Organization established in
accordance with subsection (c).
(7) The term ``Secretary'' means the Secretary of Health
and Human Services.
(8) The term ``ultimate user'' has the meaning given to
such term in section 102 of the Controlled Substances Act (21
U.S.C. 802).
(b) Required Participation.--Each producer of a covered
drug shall participate in--
(1) the certified national pharmaceutical stewardship
program of the National Pharmaceutical Stewardship
Organization; or
(2) another certified national pharmaceutical stewardship
program.
(c) National Pharmaceutical Stewardship Organization.--
(1) Establishment.--There shall be established in
accordance with this section a nonprofit private corporation
to be known as the National Pharmaceutical Stewardship
Organization. The organization shall not be an agency or
instrumentality of the Federal Government, and officers,
employees, and members of the board of the organization shall
not, by virtue of such service, be considered officers or
employees of the Federal Government.
(2) Purpose.--The purpose of the organization shall be to
establish and, beginning not later than 2 years after the
date of enactment of this title, implement a certified
national pharmaceutical stewardship program.
(3) Board of directors.--
(A) Representation.--The organization shall have a board of
directors with balanced representation of each of the
following:
(i) Producers of covered drugs.
(ii) Public health, pharmacy, law enforcement, and
substance use disorder treatment professionals.
(iii) Water quality and waste management stakeholders.
(B) Initial members.--The Secretary shall appoint the
initial members of the board of directors.
(4) Powers.--
(A) In general.--The organization may--
(i) adopt and amend a constitution and bylaws for the
management of its property and the regulation of its affairs;
(ii) adopt and alter a corporate seal;

[[Page S1152]]

(iii) choose officers, managers, agents, and employees as
the activities of the organization require;
(iv) make contracts;
(v) acquire, own, lease, encumber, and transfer property as
necessary to carry out the purposes of the organization;
(vi) borrow money, issue instruments of indebtedness, and
secure its obligations by granting security interests in its
property;
(vii) sue and be sued; and
(viii) do any other act necessary and proper to carry out
the purpose of the organization.
(B) Bylaws.--The board of directors shall establish the
general policies of the organization for carrying out the
purpose described in paragraph (2), including the
establishment of the bylaws of the organization, which shall
include bylaws for the following:
(i) Entering into contracts and agreements with service
providers and entities as necessary, useful, or convenient to
provide all or portions of the national pharmaceutical
stewardship program of the organization.
(ii) Taking any legal action necessary or proper for the
recovery of an assessment for, on behalf of, or against
producers of a covered drug participating in such program.
(iii) Performing other such functions as may be necessary
or proper to carry out the purpose described in paragraph
(2).
(iv) Ensuring that the members of the board of directors
serve without compensation, but are entitled to reimbursement
(solely from the funds of the organization) for expenses
incurred in the discharge of their duties as members of the
board of directors.
(v) Ensuring that the organization does not use any
Federal, State, or local government funds to carry out the
purpose described in paragraph (2).
(vi) Allowing the Secretary--

(I) to audit the activities of the organization as the
Secretary deems necessary; and
(II) to access any facilities or property of the
organization as the Secretary deems necessary to conduct
inspections or investigate complaints.

(5) Nonprofit status.--In carrying out the purpose
described in paragraph (2), the board of directors shall
establish such policies and bylaws under paragraph (4)(B) as
may be necessary to ensure that the organization maintains
its status as an organization that--
(A) is described in subsection (c)(3) of section 501 of the
Internal Revenue Code of 1986; and
(B) is, under subsection (a) of such section, exempt from
taxation.
(6) Contributions to national pharmaceutical stewardship
organization not treated as charitable contributions.--A
contribution (including any payment or fee) by a producer of
a covered drug to the organization or the organization's
national pharmaceutical stewardship program shall not be
treated as a charitable contribution for purposes of section
170 of the Internal Revenue Code of 1986.
(7) Articles of incorporation.--The Secretary shall ensure
that the initial articles of incorporation of the
organization are properly filed not later than 60 days after
the date of enactment of this title.
(d) Program Requirements.--To be certified (and maintain
certification) under subsection (g) or (h), a national
pharmaceutical stewardship program (referred to in this
section as a ``program'') shall meet each of the following
requirements:
(1) The program is operated pursuant to an agreement among
the producers of covered drugs participating in the program.
(2) Subject to subsection (e), the costs of the program are
fully paid by such producers.
(3) The program shall not impose any fee on individuals,
wholesalers, or retailers for transport and disposal of a
covered drug through the program, except to the extent an
individual, wholesaler, or retailer is acting as a producer
of a covered drug.
(4) The program is developed with input from the public,
including an opportunity for public comment and public
hearings.
(5) The program provides a system to facilitate the
collection and disposal of any covered drug that--
(A) is delivered to the program by the ultimate user of the
covered drug in the United States; and
(B) is household waste as defined under the implementing
regulations of subtitle C of title II of the Solid Waste
Disposal Act (42 U.S.C. 6901 et seq.; commonly referred to as
the ``Resource Conservation and Recovery Act'').
(6) Collection and disposal of a covered drug through the
program's system (described in paragraph (5)) occurs only in
a manner that--
(A) is safe and secure;
(B) results in the covered drug being rendered
unrecoverable in accordance with the requirements for
nonretrievable disposal of controlled substances under part
1300 of title 21, Code of Federal Regulations (or any
successor regulations);
(C) protects patient information;
(D) is accessible in every State, county, and city or town,
by including--
(i) at least one collection site that is accessible on an
ongoing, year-round basis in every county of every State and
at least one additional such collection site for every 30,000
county residents, giving preference to retail pharmacies
that--

(I) operate secure collection receptacles in accordance
with applicable regulations of the Drug Enforcement
Administration; and
(II) are geographically distributed to provide reasonably
convenient and equitable access;

(ii) if ongoing, year-round collection is not feasible in a
specific county or city (as determined by the Secretary)--

(I) periodic collection events; or
(II) the provision of prepaid mailing envelopes or
deactivation technologies to individuals in such county or
city; and

(iii) prepaid mailing envelopes or deactivation
technologies made available to individuals with disabilities
and home-bound residents upon request through the program's
toll-free telephone number and website under paragraph (8);
and
(E) in the case of a controlled substance, is consistent
with section 302(g) of the Controlled Substances Act (21
U.S.C. 822(g)).
(7) The program--
(A) promotes the collection and disposal of covered drugs
through the program; and
(B) to the extent feasible, works with local recycling
facilities and officials to collect and recycle covered drug
packaging at collection locations.
(8) The program ensures that options for collection and
disposal of covered drugs through the program are widely
understood by customers, pharmacists, retailers, and health
care practitioners including doctors and other prescribers,
including by--
(A) maintaining a toll-free telephone number, a website
optimized for mobile platforms, and a free mobile application
that--
(i) publicize all currently available collection and
disposal options, updated within 30 days of any change; and
(ii) provide substance use disorder treatment and referral
information;
(B) preparing educational and outreach materials that--
(i) clearly explain what ``covered drugs'' are collected at
each collection site;
(ii) describe where and how to dispose of covered drugs
through the program;
(iii) address the risks of diversion of covered drugs,
including accidental overdose, accidental poisoning, and
environmental contamination;
(iv) raise awareness about the importance of safe storage
and disposal; and
(v) utilize plain language and explanatory images readily
understandable by all residents, including individuals with
limited English proficiency; and
(C) providing such materials to pharmacies, health care
facilities, and other interested parties for dissemination.
(9) Every 4 years, the program, using an independent
evaluator at the expense of the program, evaluates the
effectiveness of its educational and outreach activities
under paragraph (8), including with respect to--
(A) the percentage of residents of the United States who
are aware of the program;
(B) the percentage of residents of the United States who
report having access to a collection site, prepaid mail-back
envelope, or deactivation system; and
(C) the extent to which residents of the United States find
the program to be convenient.
(10) Annually, the program, using an independent auditor at
the expense of the program, audits relevant information
provided in the program's report to the Secretary,
including--
(A) the amount, by weight, of covered drugs collected and
disposed of in each State by drop-off site and, if
applicable, the total amount by weight collected by mail-back
method and disposed of; and
(B) the income and expenditures of the program.
(e) Mechanism for Transfer of Costs Among Producers.--To be
certified (and maintain certification) under subsection (g)
or (h), a program shall include a mechanism that--
(1) provides for receiving and transferring of funds among
all national pharmaceutical stewardship programs that are so
certified in such amounts as may be necessary, to be adjusted
on at least an annual basis, to ensure that the producers of
covered drugs participating in such programs bear the costs
of such programs in a manner that provides for a fair and
reasonable allocation of such costs across such participants;
and
(2) is specified in a written agreement among all producers
of covered drugs.
(f) Program Reporting Requirements.--
(1) In general.--To be certified (and maintain
certification) under subsection (g) or (h), a program shall
agree to submit a report to the Secretary within one year
following such certification, and annually thereafter.
(2) Contents.--Each report submitted by a program under
paragraph (1) shall describe the program's activities during
the preceding calendar year, including at a minimum--
(A) a list of producers participating in the program;
(B) a specification of the amount, by weight, of covered
drugs collected and disposed of in each State--
(i) by drop-off site; and
(ii) if applicable, by mail-back method;
(C) a description of the collection system in each State,
including the location of each collection site and, if
applicable, locations where envelopes for mail-back or
deactivation technologies are provided;
(D) an identification of any safety or security problems
which occurred during collection, transportation, or disposal
of covered drugs during the preceding calendar year and, with
respect to any such problems, a description of the changes
which have or will be made to policies, procedures, or
tracking mechanisms to alleviate any such problems

[[Page S1153]]

and to improve safety and security in the future;
(E) a description of the educational and outreach
activities under subsection (d)(8) and the methodology used
to evaluate such activities under subsection (d)(9);
(F) a description of how collected packaging was recycled
to the extent feasible, including the recycling facility or
facilities used; and
(G) the total expenditures of the program.
(3) Procedures.--The Secretary shall establish procedures
for reporting under this subsection not later than the date
that is one year after the date of the enactment of this
title.
(4) Public availability.--The Secretary shall make each
report submitted under this subsection available to the
public.
(g) Certification of National Pharmaceutical Stewardship
Organization's Program.--
(1) Program plan.--To seek certification of its program,
the organization shall submit a plan to the Secretary
containing such information as the Secretary may require.
(2) Consideration by secretary.--Upon receipt of a plan
under paragraph (1), the Secretary--
(A) shall consult with the Administrator of the Drug
Enforcement Administration on the adequacy of the proposed
program's security measures for collection, transportation,
and disposal of covered drugs, disposal systems, and
mechanisms for secure tracking and handling;
(B) shall consult with the Administrator of the
Environmental Protection Agency on the adequacy of the
program's disposal methods and compliance with environmental
requirements;
(C) shall consult with the Secretary of Transportation on
the adequacy of the program's compliance with respect to
requirements for transport of covered drugs; and
(D) within 90 days after receipt of the plan, shall--
(i) certify the program if the Secretary determines it
meets the requirements of this section; or
(ii) reject the proposed program and provide a written
explanation of the reasons for such rejection.
(3) Response to rejection of proposed program.--If the
Secretary rejects the organization's proposed program under
paragraph (2)(D)(ii), the rejection shall be treated as final
agency action, and the organization may--
(A) revise its proposed program and submit a new plan under
paragraph (1); or
(B) seek judicial review of the rejection not later than 60
days after receiving notice of the rejection.
(4) Term of certification; recertification.--The term of a
certification (including a recertification) under paragraph
(2)(D)(i) shall be not more than 2 years. To have its program
recertified, the organization shall submit a new plan under
paragraph (1), including any relevant updates, for approval
under paragraph (2)(D)(i).
(5) Changes to certified program.--Before making any
significant change to its certified national pharmaceutical
stewardship program, the organization shall seek and obtain
approval for the change from the Secretary. Not later than 15
days after submission of a request for a change under the
preceding sentence, the Secretary shall approve the change or
reject the change and provide a written explanation of the
reasons for the rejection.
(6) Submission requirements.--
(A) Publication.--Not later than 6 months after the date of
the enactment of this title, the Secretary shall publish
requirements for the submission of program plans under
paragraph (1) and requests for changes under paragraph (5),
including requirements for the contents of such submissions.
(B) Failure to publish.--If the Secretary fails to publish
such requirements by the deadline specified in subparagraph
(A), the requirements of this section applicable to producers
of covered drugs shall nonetheless apply.
(h) Certification of Other Programs.--
(1) Application.--In lieu of participating in the certified
national pharmaceutical stewardship program of the
organization, one or more producers of a covered drug may
submit a stewardship plan to the Secretary seeking
certification of a separate national pharmaceutical
stewardship program.
(2) Governing provisions.--The provisions of subsection (g)
shall apply with respect to a stewardship plan for
certification of a program under paragraph (1) to the same
extent and in the same manner as such provisions apply to a
program plan for certification of a program by the
organization under subsection (g), except as follows:
(A) The reference to 90 days in subsection (g)(2)(D)
(relating to the period of the Secretary's review of a
program plan) shall be treated as a reference to 120 days.
(B) If the Secretary rejects the proposed stewardship plan,
in lieu of submitting a new stewardship plan under paragraph
(1) or seeking judicial review of the rejection, the
producers may choose to participate in the certified national
pharmaceutical stewardship program of the organization.
(C) The reference to 2 years in subsection (g)(4) (relating
to the term of certification) shall be treated as references
to 1 year.
(i) Solicitation of Public Comment To Inform Program
Updates.--
(1) In general.--A certified national product stewardship
program shall--
(A) annually invite comments from stakeholders on their
satisfaction with the services provided by the program,
including representatives of health care facilities,
prescribers, pharmacies and pharmacists, State and local
government officials, law enforcement personnel, public
health organizations, substance use disorder professionals,
waste management stakeholders, environmental organizations,
and consumers;
(B) compile and submit the information received through
such comments to the Secretary; and
(C) use such information in developing updates and changes
to the program.
(2) Use by secretary.--The Secretary shall use information
submitted under paragraph (1)(B) in reviewing proposed
updates and revisions to certified national pharmaceutical
stewardship program plans.
(3) Guidance.--The Secretary shall issue guidance on the
process for complying with this subsection.
(j) Suspension of Program.--
(1) Imminent danger.--The Secretary may suspend, in whole
or in part, the certification of any national pharmaceutical
stewardship program under this section if the Secretary
determines that such action is necessary to protect the
public from imminent danger.
(2) Failure to comply.--If the Secretary determines that a
national pharmaceutical stewardship is in violation of the
requirements of this section, the Secretary--
(A) within 30 days of learning of the violation, may issue
a written warning to the program stating that the program is
in violation of this section; and
(B) if the program has not rectified each violation
identified in such warning within 30 days of receipt of such
warning, may suspend, in whole or in part, the certification
of the program.
(k) Civil Penalties.--Beginning on the date that is 2 years
after the date of enactment of this title, a producer of a
covered drug shall be liable for a civil penalty of not more
than $50,000 for each calendar day on which, as determined by
the Secretary, the producer--
(1) is not participating in a certified national
pharmaceutical program; or
(2) is in violation of its obligation to contribute to the
costs of such a program under subsection (d)(2).
(l) Regulatory Power.--The Secretary may adopt rules or
guidance necessary to implement, administer, and enforce this
section. The Secretary, in consultation with the
Administrator of the Environmental Protection Agency, the
Administrator of the Drug Enforcement Administration, the
Director of National Drug Control Policy, the Secretary of
Transportation, and the Commissioner of Food and Drugs, may
include in such regulations or guidance any performance
standards determined appropriate for implementing the program
requirements specified in this section.
(m) State, Tribal, and Local Regulation.--Nothing in this
title prohibits a State, tribal, or local government from
imposing any requirements relating to the safe and secure
disposal of covered drugs that are more stringent than the
requirements of this title.
(n) Report to Congress.--Not later than 5 years after the
date of enactment of this title, the Secretary shall report
to the appropriate committees of the Congress concerning the
status of the national pharmaceutical stewardship programs
under this section, including any recommendations for changes
to this section.
(o) Severability.--If any provision of this section or the
application of such provision to any person or circumstance
is held to be unconstitutional, the remainder of this
section, and the application of the provisions of such
remainder to any person or circumstance, shall not be
affected thereby.
(p) Evaluation.--
(1) In general.--Not later than 2 years after the date of
the enactment of this title, and annually thereafter, the
Director of the Office of the National Drug Control Policy,
in consultation with the Secretary of Health and Human
Services, the Attorney General, and the Administrator of the
Drug Enforcement Administration, shall--
(A) conduct an evaluation of the effectiveness of the
national pharmaceutical stewardship programs under this
section; and
(B) submit a report to the Congress on the results of each
such evaluation, including recommendations for improving the
programs.
(2) Metrics.--The evaluation under paragraph (1) shall
address each of the following:
(A) Public access to national pharmaceutical stewardship
programs under this section.
(B) Public awareness of such programs, including awareness
of the risks of diversion of drugs and awareness of the
importance of safe storage and safe disposal of
pharmaceuticals.
(C) Impact of the programs on prescription drug abuse,
including analysis of hospital admissions for prescription
drug overdoses, per capita deaths due to prescription drug
overdoses, and arrests for illegal possession of controlled
substances in schedule II, III, IV, or V.
(q) Annual Fees.--The Secretary may assess, collect, and
use, without further appropriation, annual fees from
producers of covered drugs to pay the administrative costs of
carrying out this section and section 803.
(r) Delayed Applicability.--In the case of producer that
first offers a covered drug for

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sale in interstate commerce (including by importing the
covered drug) after the date of enactment of this title, the
requirements of this title apply with respect to such
producer beginning on the date that is 180 days after the
date on which the producer first offers the covered drug for
sale in interstate commerce.

SEC. 803. COORDINATED EDUCATION CAMPAIGN ON DRUG DISPOSAL.

Not later than 18 months after the date of the enactment of
this title, the Director of the Office of National Drug
Control Policy, in consultation with the Secretary of Health
and Human Services and the Administrator of the Environmental
Protection Agency, shall establish and begin implementation
of a coordinated education and outreach campaign--
(1) to increase awareness among members of the public
regarding how drugs may be safely and securely disposed
consistent with public safety, public health, and
environmental protection through national pharmaceutical
stewardship programs established under section 802 and by
other appropriate means; and
(2) to link members of the public to the national and local
educational and outreach activities conducted by such
programs.
______