[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3089 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 3089
To amend section 503A of the Federal Food, Drug, and Cosmetic Act with
respect to pharmacy compounding.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 12, 2013
Mr. Griffith of Virginia (for himself, Ms. DeGette, and Mr. Gene Green
of Texas) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend section 503A of the Federal Food, Drug, and Cosmetic Act with
respect to pharmacy compounding.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Compounding Clarity Act of 2013''.
SEC. 2. TRADITIONAL PHARMACY COMPOUNDING.
Section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
353a) is amended to read as follows:
``SEC. 503A. TRADITIONAL PHARMACY COMPOUNDING.
``(a) In General.--Sections 501(a)(2)(B), 502(f)(1), and 505 of
this Act and section 351 of the Public Health Service Act shall not
apply to a drug product for human use if each of the following
conditions is met:
``(1) Identified patient and receipt of prescription.--The
drug product is compounded in accordance with one of the
following:
``(A) In general.--The drug product is compounded
by a licensed pharmacist in a State-licensed pharmacy
or a Federal facility, or by a licensed physician, for
an identified individual patient based on the receipt
of a valid prescription.
``(B) Anticipatory compounding.--The drug product
is compounded by a licensed pharmacist in a State-
licensed pharmacy or a Federal facility, or by a
licensed physician, in limited quantities before the
receipt of a valid prescription for an identified
individual patient, based on--
``(i) historical demand for the drug
product; and
``(ii) a history of prescriptions for the
drug product generated solely within an
established relationship between the licensed
pharmacist or licensed physician who is
performing the compounding and--
``(I) the individual patient; or
``(II) the physician or other
licensed practitioner who writes the
prescription.
``(C) Compounding for office use.--The drug product
is compounded by a licensed pharmacist in a State-
licensed pharmacy or a Federal facility, or by a
licensed physician, pursuant to a non-patient-specific
purchase order and--
``(i) the drug product will be administered
by a health care practitioner within a
physician's office, a hospital, or another
health care setting;
``(ii) valid patient-specific prescriptions
or, when a compounded drug product is
administered within the same health system in
which it was compounded, valid patient names--
``(I) are submitted, electronically
or otherwise, to the pharmacist or
physician who performs the compounding,
not later than 7 business days after
the drug product is administered; and
``(II) will, in the aggregate,
account for the total volume of drug
product compounded pursuant to the non-
patient-specific purchase order;
``(iii) during any 6-month period, of the
total drug products dispensed from the facility
at which the drug product was compounded, not
more than 5 percent are compounded sterile drug
products that are--
``(I) dispensed pursuant to this
subparagraph; and
``(II) shipped interstate;
``(iv) records of the compounding will be
kept for not less than 3 years; and
``(v) the statement `Office Use Only' and
the statement `Not for resale' appear on the
compounded drug product.
Compounding under this subparagraph shall not be
considered to be in violation of clause (ii) because of
the failure of a pharmacist or a physician to account
for valid patient-specific prescriptions or valid
patient names as required by such clause, so long as
the pharmacist or physician makes a good faith,
reasonable effort to account for the prescriptions or
names, as applicable, and does not continue to compound
drug products under this subparagraph for a health care
practitioner or facility with a history of failing to
submit such prescriptions or patient names.
``(2) Quality standards.--Irrespective of whether a drug
product is compounded under subparagraph (A), (B), or (C) of
paragraph (1), the drug product is compounded, stored, and
dated in compliance with the United States Pharmacopoeia
chapters that are applicable to pharmaceutical compounding
(including the chapter on sterile preparations).
``(3) Bulk drug substances.--If the drug product is
compounded using bulk drug substances (as defined in
regulations of the Secretary published at section 207.3(a)(4)
of title 21 of the Code of Federal Regulations (or any
successor regulations))--
``(A) the bulk drug substances--
``(i) if an applicable monograph exists
under the United States Pharmacopoeia, the
National Formulary, or another compendium or
pharmacopeia recognized under Federal law, each
comply with the monograph;
``(ii) if such a monograph does not exist,
each are drug substances that are components of
drug products approved or licensed by the
Secretary for human use; or
``(iii) if such a monograph does not exist
and the drug substance is not a component of a
drug product so approved or licensed, each
appear on a list published by the Secretary
(through regulations issued under subsection
(e));
``(B) the bulk drug substances are each
manufactured by an establishment that is registered
under section 510 (including a foreign establishment
that is registered under section 510(i)); and
``(C) the bulk drug substances are each accompanied
by a valid certificate of analysis.
``(4) Ingredients (other than bulk drug substances).--If
any ingredients (other than bulk drug substances) are used in
compounding the drug product, such ingredients comply with the
standards of an applicable United States Pharmacopoeia or
National Formulary monograph.
``(5) Drug products withdrawn or removed because unsafe or
not effective.--The drug product does not appear on a list
published by the Secretary of drug products that have been
withdrawn or removed from the market because such drug products
or components of such drug products have been found to be
unsafe or not effective.
``(6) Essentially a copy of a marketed and approved drug
product.--The licensed pharmacist or licensed physician does
not compound any drug product that is essentially a copy of a
marketed and approved drug product.
``(7) Drug products presenting demonstrable difficulties
for compounding.--The drug product is not identified (directly
or as part of a category of drug products) in a list published
by the Secretary (through regulations issued under subsection
(e)) as a drug product that presents demonstrable difficulties
for compounding that reasonably demonstrate an adverse effect
on the safety or effectiveness of that drug product.
``(8) Prohibition on wholesaling.--The drug product will
not be sold by an entity other than the pharmacy or physician
that compounded such drug product.
``(b) State Regulation.--Nothing in this section shall prevent a
State from--
``(1) imposing restrictions on the type of compounding
described in subparagraph (B) or (C) of subsection (a)(1) that
are in addition to the restrictions applicable under this
section; or
``(2) enforcing requirements or restrictions contained in
the chapters or standards described in subsection (a)(2).
``(c) Notification System.--
``(1) Development and implementation.--The Secretary shall
develop and implement a system for receiving and reviewing
submissions from State boards of pharmacy--
``(A) describing actions taken against compounding
pharmacies; or
``(B) expressing concerns that a compounding
pharmacy may be acting in violation of one or more
requirements of this section.
``(2) Content of submissions from state boards of
pharmacy.--An action referred to in paragraph (1)(A) is, with
respect to a pharmacy that compounds drug products, any of the
following:
``(A) The issuance of a warning letter, or the
imposition of sanctions or penalties, by a State for
violations of a State's pharmacy regulations pertaining
to compounding.
``(B) The suspension or revocation of a State-
issued pharmacy license or registration.
``(C) The recall of compounded drug products due to
concerns relating to the quality or purity of such
products.
``(3) Consultation.--The Secretary shall develop the system
under paragraph (1) in consultation with the National
Association of Boards of Pharmacy.
``(4) Review and determination by secretary.--The Secretary
shall review each submission received under paragraph (1) and
such other information as the Secretary determines necessary
(including information collected through an inspection or
maintained in the Adverse Event Reporting System database) and
make a determination as to whether the pharmacy involved may be
in violation of one or more requirements of this section.
``(5) Notifying state boards of pharmacy.--The system under
paragraph (1) shall be designed to immediately notify State
boards of pharmacy when--
``(A) the Secretary receives a submission under
paragraph (1); or
``(B) the Secretary makes a determination that a
pharmacy may be in violation of one or more
requirements of this section.
``(6) Timing.--Not later than one year after the date of
enactment of the Compounding Clarity Act of 2013, the Secretary
shall begin implementation of the system under paragraph (1).
``(d) Inspection Authority.--In accordance with section 704(a), the
Secretary may inspect a pharmacy's records to determine whether the
pharmacy is in violation of one or more requirements of this Act if--
``(1) the inspection is conducted in coordination with the
relevant State board or boards of pharmacy; or
``(2) the Secretary has evidence that the pharmacy may be
in violation of such a requirement.
``(e) Regulations.--
``(1) In general.--The Secretary shall issue regulations to
implement this section.
``(2) Advisory committee on compounding.--Before issuing
regulations to implement subsections (a)(3)(A)(iii) and (a)(7),
the Secretary shall convene and consult an advisory committee
on compounding. The advisory committee shall include
representatives from the National Association of Boards of
Pharmacy, the United States Pharmacopoeia, pharmacists having
current experience and expertise in compounding, physicians
having background and knowledge in compounding, and consumer
organizations with an expertise in compounding.
``(3) Interim lists.--Before the date on which final
regulations are issued to implement subsections (a)(3)(A)(iii)
and (a)(7), if the Secretary determines it is necessary to
protect the public health, the Secretary may designate drug
products or substances as described in such subsections, by--
``(A) publishing a notice of such drug products or
substances proposed for designation, including the
rationale for such designation, in the Federal
Register;
``(B) providing a period of not less than 60
calendar days for comment on the notice; and
``(C) publishing a notice in the Federal Register
designating such drug products or substances.
``(4) Updating lists.--The Secretary shall update the
regulations containing the lists of drug products and
substances described in subsections (a)(3)(A)(iii) and (a)(7)
regularly, but not less than once every three years.
``(5) Sunset of notice.--Any notice published under
paragraph (3) shall not be effective after the earlier of--
``(A) the date that is 3 years after the date of
Compounding Clarity Act of 2013; and
``(B) the effective date of the final regulations
issued to implement subsections (a)(3)(A)(iii) and
(a)(7).
``(f) Definitions.--In this section:
``(1) The term `compounding' includes--
``(A) the combining, admixing, mixing, diluting,
reconstituting, or otherwise altering of a marketed
drug product, except when performed in accordance with
specific directions for such acts contained in approved
labeling provided by the product's manufacturer or
otherwise provided by that manufacturer consistent with
that labeling;
``(B) the combining, admixing, mixing, diluting,
reconstituting, or otherwise altering a bulk drug
substance to create a drug product; and
``(C) repackaging.
``(2) The term `essentially a copy of a marketed and
approved drug product' does not include--
``(A) a drug product in which there is a change,
made for an identified individual patient, which
produces for that patient a clinical difference, as
determined by the prescribing practitioner, between the
compounded drug product and the comparable marketed and
approved drug product; or
``(B) a drug product that appears on the drug
shortage list in effect under section 506E.
``(3) The term `licensed pharmacist' includes any
individual who compounds drug products under the supervision of
a practitioner licensed to compound drug products under State
law.
``(4) The term `marketed and approved drug product' means a
drug product that--
``(A) is currently marketed; and
``(B) is approved under section 505 of this Act or
licensed under section 351 of the Public Health Service
Act.
``(5)(A) The term `repackaging' means taking a drug
approved under section 505 of this Act or licensed under
section 351 of the Public Health Service Act from the container
in which the drug is distributed by the original manufacturer
and placing such drug in a different container of the same or
smaller size without further manipulating the drug (such as by
diluting it or mixing it with another, different drug or
drugs).
``(B) Such term does not include removing the drug from its
original container for immediate administration to an
identified individual patient, such as withdrawing a drug into
a syringe for immediate injection or removing the drug from its
original container within a health care entity by a
practitioner, or other licensed individual under the
supervision or direction of such practitioner, for
administration within the same day within such health care
entity.''.
SEC. 3. OUTSOURCING FACILITIES.
(a) In General.--Subchapter A of chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended--
(1) by redesignating section 503B as section 503C; and
(2) by inserting after section 503A (21 U.S.C. 353a) the
following new section:
``SEC. 503B. OUTSOURCING FACILITIES.
``(a) In General.--Sections 502(f)(1) and 505 of this Act and
section 351 of the Public Health Service Act shall not apply to a drug
product compounded for human use by a licensed pharmacist in an
outsourcing facility if each of the following conditions is met:
``(1) Registration and reporting.--The facility is in
compliance with the registration and reporting requirements of
subsection (b).
``(2) Drug product and substance limitations.--The facility
does not compound drug products in violation of paragraphs (3)
through (8) of section 503A(a).
``(3) Fees.--The facility has paid all fees owed by such
facility pursuant to section 744K.
``(4) Standardized drug products from bulk.--The facility
does not compound, from bulk drug substances, standardized
dosages that are not otherwise commercially available of a
marketed and approved drug product.
``(5) Labeling of drug products.--
``(A) Label.--The label of a drug product
compounded by an outsourcing facility shall include--
``(i) the statement `This is a compounded
drug.' or a reasonable comparable alternative
statement (as specified by the Secretary) that
prominently identifies the drug as a compounded
drug product;
``(ii) the name, address, and phone number
of the applicable outsourcing facility; and
``(iii) with respect to the compounded drug
product--
``(I) the lot or batch number;
``(II) the established name of the
drug product;
``(III) the dosage form and
strength;
``(IV) the statement of quantity or
volume, as appropriate;
``(V) the date that the drug
product was compounded;
``(VI) the expiration date;
``(VII) storage and handling
instructions;
``(VIII) the National Drug Code
number, if available;
``(IX) the `Not for resale'
statement required under section
503A(a)(1)(C)(v); and
``(X) subject to subparagraph
(B)(i), a list of active and inactive
ingredients, identified by established
name and the quantity or proportion of
each ingredient.
``(B) Container.--The container from which the
individual units of a drug product compounded by an
outsourcing facility are removed for dispensing or for
administration (such as a plastic bag containing
individual product syringes) shall include--
``(i) the information described under
subparagraph (A)(iii)(X), if there is not space
on the label for such information;
``(ii) the following information to
facilitate adverse event reporting:
www.fda.gov/medwatch and 1-800-FDA-1088; and
``(iii) directions for use, including, as
appropriate, dosage and administration.
``(C) Additional information.--The label and
labeling of a drug product compounded by an outsourcing
facility shall include any other information as
determined necessary and specified in regulations
promulgated by the Secretary
``(b) Registration of Outsourcing Facilities and Reporting of Drug
Products.--
``(1) Registration of outsourcing facilities.--
``(A) Annual registration.--During the period
beginning on October 1 and ending on December 31 each
year, each outsourcing facility--
``(i) shall register with the Secretary its
name, place of business, and unique facility
identifier (which shall conform to the
requirements for the unique facility identifier
established under section 510), and a point of
contact e-mail address; and
``(ii) shall indicate whether the
outsourcing facility intends to compound a drug
product that appears on the list in effect
under section 506E during the subsequent
calendar year.
``(B) New outsourcing facilities.--Each outsourcing
facility, upon first engaging in compounding pursuant
to this section, shall immediately register with the
Secretary and provide the information described in
paragraph (1)(A). The Secretary shall establish a
timeline for registration for the first calendar year
following the effective date of the Compounding Clarity
Act of 2013. In no case may registration be required
until at least 60 calendar days following publication
of the timeline in the Federal Register.
``(C) Availability of registration for inspection;
list.--
``(i) Registrations.--The Secretary shall
make available for inspection, to any person so
requesting, any registration filed pursuant to
this paragraph.
``(ii) List.--The Secretary shall make
available on the public Internet Web site of
the Food and Drug Administration a list of the
name of each facility registered under this
subsection as an outsourcing facility, the
State in which each such facility is located,
whether the facility compounds from bulk drug
substances, and whether any such compounding
from bulk drug substances is for sterile or
non-sterile drug products.
``(2) Drug product reporting by outsourcing facilities.--
``(A) In general.--Upon initially registering as an
outsourcing facility, once during the month of June of
each year, and once during the month of December of
each year, each outsourcing facility that registers
with the Secretary under paragraph (1) shall submit to
the Secretary a report--
``(i) identifying the drug products
compounded by such outsourcing facility during
the previous 6-month period; and
``(ii) with respect to each drug product
identified under clause (i), providing the
active ingredient; the source of such active
ingredient; the National Drug Code number, if
available, of the source drug product or bulk
active ingredient; the strength of the active
ingredient per unit; the dosage form and route
of administration; the package description; the
number of individual units produced; and the
National Drug Code number of the final product,
if assigned.
``(B) Form.--Each report under subparagraph (A)
shall be prepared in such form and manner as the
Secretary may prescribe by regulation or guidance.
``(C) Confidentiality.--Reports submitted under
this paragraph shall be exempt from inspection under
paragraph (1)(C), unless the Secretary finds that such
an exemption would be inconsistent with the protection
of the public health.
``(3) Electronic registration and reporting.--Registrations
and drug product reporting under this subsection (including the
submission of updated information) shall be submitted to the
Secretary by electronic means unless the Secretary grants a
request for waiver of such requirement because use of
electronic means is not reasonable for the person requesting
waiver.
``(4) Risk-based inspection frequency.--
``(A) In general.--Outsourcing facilities--
``(i) shall be subject to inspection
pursuant to section 704; and
``(ii) shall not be eligible for the
exemption under section 704(a)(2)(A).
``(B) Risk-based schedule.--The Secretary, acting
through one or more officers or employees duly
designated by the Secretary, shall inspect outsourcing
facilities in accordance with a risk-based schedule
established by the Secretary.
``(C) Risk factors.--In establishing the risk-based
schedule, the Secretary shall inspect outsourcing
facilities according to the known safety risks of such
outsourcing facilities, which shall be based on the
following factors:
``(i) The compliance history of the
outsourcing facility.
``(ii) The record, history, and nature of
recalls linked to the outsourcing facility.
``(iii) The inherent risk of the drug
products compounded at the outsourcing
facility.
``(iv) The inspection frequency and history
of the outsourcing facility, including whether
the outsourcing facility has been inspected
pursuant to section 704 within the last 4
years.
``(v) Whether the outsourcing facility has
registered under this paragraph as an entity
that intends to compound a drug product that
appears on the list in effect under section
506E.
``(vi) Any other criteria deemed necessary
and appropriate by the Secretary for purposes
of allocating inspection resources.
``(5) Adverse event reporting.--Outsourcing facilities
shall be required to submit adverse event reports to the
Secretary in accordance with the content and format
requirements established through guidance or regulation under
section 310.305 of title 21, Code of Federal Regulations (or
any successor regulations) or section 600.80 of title 21, Code
of Federal Regulations (or any successor regulations).
``(c) Definitions.--In this section:
``(1) Outsourcing facility.--The term `outsourcing
facility' means a facility at one geographic location or
address that compounds sterile drug products for office use in
excess of the limitation set forth in section
503A(a)(1)(C)(iii).
``(2) Other definitions.--The terms `compounding',
`essentially a copy of a marketed and approved drug product',
`licensed pharmacist', and `marketed and approved drug product'
have the meanings given such terms in section 503A(f).''.
(b) Fees.--Subchapter C of chapter VII of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379f et seq.) is amended by adding at the
end the following:
``PART 9--FEES RELATING TO OUTSOURCING FACILITIES
``SEC. 744J. DEFINITIONS.
``In this part:
``(1) The term `affiliate' has the meaning given such term
in section 735(11).
``(2) The term `gross annual sales' means the total
worldwide gross annual sales, in United States dollars, for an
outsourcing facility, including the sales of all the affiliates
of the outsourcing facility.
``(3) The term `outsourcing facility' has the meaning given
to such term in section 503B(c).
``(4) The term `reinspection' means, with respect to an
outsourcing facility, one or more inspections conducted under
section 704 subsequent to an inspection conducted under such
provision which identified noncompliance materially related to
an applicable requirement of this Act, specifically to
determine whether compliance has been achieved to the
Secretary's satisfaction.
``SEC. 744K. AUTHORITY TO ASSESS AND USE OUTSOURCING FACILITY FEES.
``(a) Establishment and Reinspection Fees.----
``(1) In general.--For fiscal year 2015 and each subsequent
fiscal year, the Secretary shall, in accordance with this
subsection, assess and collect--
``(A) an annual establishment fee from each
outsourcing facility; and
``(B) a reinspection fee from each outsourcing
facility subject to a reinspection in such fiscal year.
``(2) Multiple reinspections.--An outsourcing facility
subject to multiple reinspections in a fiscal year shall be
subject to a reinspection fee for each reinspection.
``(b) Establishment and Reinspection Fee Setting.--The Secretary
shall--
``(1) establish the amount of the establishment and
reinspection fee to be collected under this section for each
fiscal year based on the methodology described in subsection
(c); and
``(2) publish such fee amounts in a Federal Register notice
not later than 60 calendar days before the start of each such
year.
``(c) Amount of Establishment Fee and Reinspection Fee.--
``(1) In general.--For each outsourcing facility in a
fiscal year--
``(A) except as provided in paragraph (4), the
amount of the annual establishment fee under subsection
(b) shall be equal to the sum of--
``(i) $15,000, multiplied by the inflation
adjustment factor described in paragraph (2);
plus
``(ii) the small business adjustment factor
described in paragraph (3); and
``(B) the amount of any reinspection fee (if
applicable) under subsection (b) shall be equal to
$15,000, multiplied by the inflation adjustment factor
described in paragraph (3).
``(2) Inflation adjustment factor.--
``(A) In general.--For fiscal year 2015 and
subsequent fiscal years, the fee amounts established in
paragraph (1) shall be adjusted by the Secretary by
notice, published in the Federal Register, for a fiscal
year by the amount equal to the sum of--
``(i) one;
``(ii) the average annual percent change in
the cost, per full-time equivalent position of
the Food and Drug Administration, of all
personnel compensation and benefits paid with
respect to such positions for the first 3 years
of the preceding 4 fiscal years, multiplied by
the proportion of personnel compensation and
benefits costs to total costs of an average
full-time equivalent position of the Food and
Drug Administration for the first 3 years of
the preceding 4 fiscal years; and
``(iii) the average annual percent change
that occurred in the Consumer Price Index for
urban consumers (U.S. City Average; Not
Seasonally Adjusted; All items; Annual Index)
for the first 3 years of the preceding 4 years
of available data multiplied by the proportion
of all costs other than personnel compensation
and benefits costs to total costs of an average
full-time equivalent position of the Food and
Drug Administration for the first 3 years of
the preceding 4 fiscal years.
``(B) Compounded basis.--The adjustment made each
fiscal year under subparagraph (A) shall be added on a
compounded basis to the sum of all adjustments made
each fiscal year after fiscal year 2014 under
subparagraph (A).
``(3) Small business adjustment factor.--The small business
adjustment factor referred to in paragraph (1)(A)(ii) shall be
an amount established by the Secretary for each fiscal year
based on the Secretary's estimate of--
``(A) the number of small businesses that will pay
a reduced establishment fee for such fiscal year; and
``(B) the adjustment to the establishment fee
necessary to achieve total fees equaling the total fees
that the Secretary would have collected if no entity
qualified for the small business exception in paragraph
(4).
``(4) Exception for small businesses.--
``(A) In general.--In the case of an outsourcing
facility with gross annual sales of $1,000,000 or less
in the 12 months ending April 1 of the fiscal year
immediately preceding the fiscal year in which the fees
under this section are assessed, the amount of the
establishment fee under subsection (b) for a fiscal
year shall be equal to \1/3\ of the amount calculated
under paragraph (1)(A)(i) for such fiscal year.
``(B) Application.--To qualify for the exception
under this paragraph, a small business shall submit to
the Secretary a written request for such exception, in
a format specified by the Secretary in guidance,
certifying its gross annual sales for the 12 months
ending April 1 of the fiscal year immediately preceding
the fiscal year in which fees under this subsection are
assessed. Any such application shall be submitted to
the Secretary not later than April 30 of such
immediately preceding fiscal year.
``(5) Crediting of fees.--In establishing the small
business adjustment factor under paragraph (3) for a fiscal
year, the Secretary shall--
``(A) provide for the crediting of fees from the
previous year to the next year if the Secretary
overestimated the amount of the small business
adjustment factor for such previous fiscal year; and
``(B) consider the need to account for any
adjustment of fees and such other factors as the
Secretary determines appropriate.
``(d) Use of Fees.--The Secretary shall make all of the fees
collected pursuant to subparagraphs (A) and (B) of subsection (a)(1)
available solely to pay for the costs of oversight of outsourcing
facilities.
``(e) Supplement Not Supplant.--Funds received by the Secretary
pursuant to this section shall be used to supplement and not supplant
any other Federal funds available to carry out the activities described
in this section.
``(f) Crediting and Availability of Fees.--Fees authorized under
this section shall be collected and available for obligation only to
the extent and in the amount provided in advance in appropriations
Acts. Such fees are authorized to remain available until expended. Such
sums as may be necessary may be transferred from the Food and Drug
Administration salaries and expenses appropriation account without
fiscal year limitation to such appropriation account for salaries and
expenses with such fiscal year limitation. The sums transferred shall
be available solely for the purpose of paying the costs of oversight of
outsourcing facilities.
``(g) Collection of Fees.--
``(1) Establishment fee.--An outsourcing facility shall
remit the establishment fee due under this section in a fiscal
year when submitting a registration pursuant to section 503B(b)
for such fiscal year.
``(2) Reinspection fee.--The Secretary shall specify in the
Federal Register notice described in subsection (b)(2) the
manner in which reinspection fees assessed under this section
shall be collected and the timeline for payment of such fees.
Such a fee shall be collected after the Secretary has conducted
a reinspection of the outsourcing facility involved.
``(3) Effect of failure to pay fees.--
``(A) Registration.--An outsourcing facility shall
not be considered registered under section 503B(b) in a
fiscal year until the date that the outsourcing
facility remits the establishment fee under this
subsection for such fiscal year.
``(B) Misbranding.--All drug products manufactured,
prepared, propagated, compounded, or processed by an
outsourcing facility for which any establishment fee or
reinspection fee has not been paid, as required by this
section, shall be deemed misbranded under section 502
until the fees owed for such outsourcing facility under
this section have been paid.
``(4) Collection of unpaid fees.--In any case where the
Secretary does not receive payment of a fee assessed under this
section within 30 calendar days after it is due, such fee shall
be treated as a claim of the United States Government subject
to provisions of subchapter II of chapter 37 of title 31,
United States Code.
``(h) Annual Report to Congress.--Not later than 120 calendar days
after each fiscal year in which fees are assessed and collected under
this section, the Secretary shall submit a report to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives, to include a
description of fees assessed and collected for such year, a summary
description of entities paying the fees, a description of the hiring
and placement of new staff, a description of the use of fee resources
to support inspecting outsourcing facilities, and the number of
inspections and reinspections of such facilities performed each year.
``(i) Authorization of Appropriations.--For fiscal year 2015 and
each subsequent fiscal year, there is authorized to be appropriated for
fees under this subsection an amount equivalent to the total amount of
fees assessed for such fiscal year under this section.''.
SEC. 4. PROHIBITED ACTS.
(a) Intentional Falsification of Prescription Order for Compounded
Drug Product.--Section 301 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331) is amended by inserting after paragraph (bbb) the
following:
``(ccc) With respect to a drug product to be compounded under
section 503A or 503B, the intentional falsification of a prescription,
a purchase order, or patient name required under section 503A or
503B.''.
(b) Intentional Failure of Outsourcing Facility To Register.--
Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
331), as amended by subsection (a), is further amended by inserting
after paragraph (ccc) (as added by such subsection), the following:
``(ddd) With respect to any year in which an outsourcing facility
is required to register with the Secretary under section 503B(b), the
intentional failure of the outsourcing facility to so register.''.
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