In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

Let me give you an example: SECTION 1. LIABILITY OF BUSINESS ENTITIES PROVIDING USE OF FACILITIES
TO NONPROFIT ORGANIZATIONS.

(a) Definitions.--In this section:
(1) Business entity.--The term ''business entity'' means a
firm, corporation, association, partnership, consortium, joint
venture, or other form of enterprise.
(2) Facility.--The term ''facility'' means any real
property, including any building, improvement, or appurtenance.
(3) Gross negligence.--The term ''gross negligence'' means
voluntary and conscious conduct by a person with knowledge (at
the time of the conduct) that the conduct is likely to be
harmful to the health or well-being of another person.
(4) Intentional misconduct.--The term ''intentional
misconduct'' means conduct by a person with knowledge (at the
time of the conduct) that the conduct is harmful to the health
or well-being of another person.
(5) Nonprofit organization.--The term ''nonprofit
organization'' means--
(A) any organization described in section 501(c)(3)
of the Internal Revenue Code of 1986 and exempt from
tax under section 501(a) of such Code; or
(B) any not-for-profit organization organized and
conducted for public benefit and operated primarily for
charitable, civic, educational, religious, welfare, or
health purposes.
(6) State.--The term ''State'' means each of the several
States, the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, American Samoa, the Northern
Mariana Islands, any other territory or possession of the
United States, or any political subdivision of any such State,
territory, or possession.
(b) Limitation on Liability.--
(1) In general.--Subject to subsection (c), a business
entity shall not be subject to civil liability relating to any
injury or death occurring at a facility of the business entity
in connection with a use of such facility by a nonprofit
organization if--
(A) the use occurs outside of the scope of business
of the business entity;
(B) such injury or death occurs during a period
that such facility is used by the nonprofit
organization; and
(C) the business entity authorized the use of such
facility by the nonprofit organization.
(2) Application.--This subsection shall apply--
(A) with respect to civil liability under Federal
and State law; and
(B) regardless of whether a nonprofit organization
pays for the use of a facility.
(c) Exception for Liability.--Subsection (b) shall not apply to an
injury or death that results from an act or omission of a business
entity that constitutes gross negligence or intentional misconduct,
including any misconduct that--
(1) constitutes a crime of violence (as that term is
defined in section 16 of title 18, United States Code) or act
of international terrorism (as that term is defined in section
2331 of title 18) for which the defendant has been convicted in
any court;
(2) constitutes a hate crime (as that term is used in the
Hate Crime Statistics Act (28 U.S.C. 534 note));
(3) involves a sexual offense, as defined by applicable
State law, for which the defendant has been convicted in any
court; or
(4) involves misconduct for which the defendant has been
found to have violated a Federal or State civil rights law.
(d) Superseding Provision.--
(1) In general.--Subject to paragraph (2) and subsection
(e), this Act preempts the laws of any State to the extent that
such laws are inconsistent with this Act, except that this Act
shall not preempt any State law that provides additional
protection from liability for a business entity for an injury
or death with respect to which conditions under subparagraphs
(A) through (C) of subsection (b)(1) apply.
(2) Limitation.--Nothing in this Act shall be construed to
supersede any Federal or State health or safety law.
(e) Election of State Regarding Nonapplicability.--This Act shall
not apply to any civil action in a State court against a business
entity in which all parties are citizens of the State if such State
enacts a statute--
(1) citing the authority of this subsection;
(2) declaring the election of such State that this Act
shall not apply to such civil action in the State; and
(3) containing no other provision.
The answer to this example can be: Shields a business entity from civil liability relating to any injury or death occurring at a facility of that entity in connection with a use of such facility by a nonprofit organization if: (1) the use occurs outside the scope of business of the business entity; (2) such injury or death occurs during a period that such facility is used by such organization; and (3) the business entity authorized the use of such facility by the organization.
Makes this Act inapplicable to an injury or death that results from an act or omission of a business entity that constitutes gross negligence or intentional misconduct, including misconduct that: (1) constitutes a hate crime or a crime of violence or act of international terrorism for which the defendant has been convicted in any court; or (2) involves a sexual offense for which the defendant has been convicted in any court or misconduct for which the defendant has been found to have violated a Federal or State civil rights law.
Preempts State laws to the extent that such laws are inconsistent with this Act, except State law that provides additional protection from liability. Specifies that this Act shall not be construed to supersede any Federal or State health or safety law.
Makes this Act inapplicable to any civil action in a State court against a business entity in which all parties are citizens of the State if such State, citing this Act's authority and containing no other provision, enacts a statute declaring the State's election that this Act shall not apply to such action in the State.
Here is why: This Bill focuses on shielding business entities from civil liability relating to an injury or death depending on the conditions of injury, hence the generated summary is correct.

OK. solve this:
SECTION 1. SHORT TITLE.

This Act may be cited as the ''Verifying Authority and Legality In
Drug Compounding Act of 2012''.

SEC. 2. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHARMACY COMPOUNDING.

(a) Amendment.--Section 503A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353a) is amended to read as follows:

''SEC. 503A. PHARMACY COMPOUNDING.

''(a) In General.--Sections 501(a)(2)(B) and 505 shall not apply
with respect to a drug product if each of the following applies:
''(1) The drug product is compounded for an identified
individual patient based on the receipt of--
''(A) a valid prescription order; or
''(B) a notation, approved by the prescribing
practitioner, on the prescription order that a
compounded product is necessary for the identified
patient.
''(2) 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 such prescription order
or notation.
''(3) The drug product is compounded exclusively from--
''(A) ingredients that comply with the standards of
an applicable United States Pharmacopoeia or National
Formulary monograph; or
''(B) if such a monograph does not exist,
ingredients that are ingredients in a drug--
''(i) for which an approval of an
application filed under subsection (b) or (j)
of section 505 is in effect; or
''(ii) that may be lawfully marketed in the
United States without such an approval pursuant
to the definition of a new drug in section 201.
''(4) Any bulk substance used for purposes of compounding
the drug product--
''(A) is manufactured by an establishment that is
registered under section 510 (including a foreign
establishment that is registered under section 510(i));
and
''(B) is accompanied by valid certificates of
analysis.
''(5) The pharmacist or physician compounding the drug
product complies with the standards of any applicable United
States Pharmacopoeia chapters on pharmacy compounding.
''(6) The drug product, including the dosage form and any
ingredient thereof, is not included in the list under
subsection (b).
''(7) The drug product is not a copy of a commercially
available drug.
''(b) List of Drug Products That Should Not Be Compounded.--
''(1) In general.--For purposes of subsection (a)(6), the
Secretary shall--
''(A) develop and maintain a list of drug products
that should not be compounded, including any
categories, dosage forms, or ingredients of such drug
products; and
''(B) include on such list, at a minimum--
''(i) drug products (or categories, dosage
forms, or ingredients thereof) whose
compounding is reasonably likely to cause an
adverse effect on safety or effectiveness of
such drug product; and
''(ii) drug products (or categories, dosage
forms, or ingredients thereof) that have been
withdrawn or removed from the market because
they have been found to be unsafe or not
effective.
''(2) Initial publication; updates.--The Secretary shall--
''(A) not later than 1 year after the date of the
enactment of the Verifying Authority and Legality In
Drug Compounding Act of 2012, publish an initial list
under paragraph (1); and
''(B) not less frequently than every year
thereafter, review and, as appropriate, update the list
under paragraph (1).
''(3) Availability.--The Secretary shall make the list
under paragraph (1) available on the public Web site of the
Food and Drug Administration.
''(4) Transmission to state regulatory agencies.--Upon
publication of the initial list under paragraph (1), and upon
each update to the list, the Secretary shall transmit an up-to-
date copy of the list to the agency in each State with primary
responsibility for regulating the compounding of drugs.
''(c) Waiver of Requirement of Individually Identified Patient for
Specified Drug Products.--
''(1) Waiver authority.--The Secretary may, with respect to
a drug product sold or dispensed by a pharmacy or pharmacist,
waive the requirement of subsection (a)(1) that the drug
product be compounded for an individually identified patient if
the Secretary determines that compounding the drug product is
necessary--
''(A) to address a drug shortage; or
''(B) to protect public health or well-being.
''(2) Duration.--The duration of a waiver under paragraph
(1) shall not exceed 1 year, unless the Secretary determines
that an extension is necessary to continue--
''(A) to address the drug shortage for which such
waiver was originally approved; or
''(B) to protect public health or well-being.
''(3) Waivers by states prohibited.--The Secretary may not
authorize any State to grant waivers under this subsection.
''(d) Waiver of Requirement of Individually Identified Patient for
Specified Pharmacies and Pharmacists.--
''(1) Waiver authority.--The Secretary may waive the
requirement of subsection (a)(1) that the drug product be
compounded for an individually identified patient if the
pharmacy or pharmacist--
''(A) submits an application that meets the
requirements of paragraph (5)(A) and is satisfactory to
the Secretary (or, subject to paragraph (3), the
State); and
''(B) agrees to comply with any condition of
operation and any limitations specified by the
Secretary as a requirement for such waiver, including
the conditions and limitations specified under
paragraph (5).
''(2) Ineligible pharmacies.--A pharmacy or pharmacist
required to be registered under section 510 for purposes of
compounding a drug product is not eligible for a waiver under
this subsection for such purposes.
''(3) Types of pharmacies eligible for waiver.--Subject to
paragraph (2), the Secretary shall specify types of pharmacies
and pharmacists that are eligible for a waiver under this
subsection, and shall include the following types:
''(A) Any pharmacy or pharmacist within a hospital
system that is compounding drug products exclusively
for dispensing to patients within that hospital system.
''(B) Any pharmacy or pharmacist that compounds
sterile drug products.
''(C) Any pharmacy or pharmacist that compounds
drug products in limited quantities before the receipt
of a valid prescription for an individual patient who
is located in the same State as the pharmacy or
pharmacist, based on a history of the pharmacy or
pharmacist receiving such valid prescription.
''(4) Waivers by states allowed.--
''(A) Memorandum of understanding.--The Secretary
may authorize a State to grant waivers under paragraph
(1) to pharmacies and pharmacists in such State
pursuant to a memorandum of understanding entered into
between the Secretary and the State--
''(i) ensuring, to the Secretary's
satisfaction, that the State's program for
granting waivers will be implemented in
accordance with the requirements of this
section (including the application of different
requirements for different types of pharmacies,
as specified under paragraph (5)(B)); and
''(ii) including such other information and
assurances as the Secretary may require.
''(B) Determination.--The Secretary shall establish
criteria and a process for determining whether to
authorize a State to grant waivers under paragraph (1).
''(C) Scope of authorization.--In authorizing a
State to grant waivers under subparagraph (A), the
Secretary may limit such authority to apply only with
respect to certain types of pharmacies and pharmacists
specified under paragraph (3).
''(D) Limitation.--A waiver granted by a State to a
pharmacy or pharmacist under subparagraph (A) shall
only apply with respect to compounded drug products
sold or dispensed within such State.
''(5) Applications; requirements.--
''(A) In general.--For each type of pharmacy or
pharmacist specified under paragraph (3), the Secretary
shall specify, in the regulations under subsection (j),
the following:
''(i) The information that is required to
be included in an application for a waiver
under paragraph (1).
''(ii) The circumstances necessary to
support the approval of such an application by
the Secretary, or by a State that is authorized
to grant waivers under paragraph (4), including
the criteria that shall be used to evaluate
such an application.
''(iii) The conditions of operation,
including good manufacturing practices and
requirements for third-party testing,
applicable to the compounding of drugs under
such a waiver.
''(iv) Any limitations on the activities
that a pharmacy or pharmacist may engage in
under such a waiver.
''(v) The duration (and renewability) of
such a waiver.
''(B) Specificity to types of pharmacies and
pharmacists.--In establishing requirements under
subparagraph (A), the Secretary shall make the
requirements specific to each type of pharmacy and
pharmacist specified by the Secretary under paragraph
(3).
''(e) Waiver of Requirement Regarding Copies of Commercially
Available Drug.--
''(1) Waiver authority.--The Secretary may, with respect to
a drug product sold or dispensed by a pharmacy or pharmacist,
waive the requirement of subsection (a)(7) if the Secretary
determines that compounding the drug product is necessary to
protect public health or well-being.
''(2) Duration.--The duration of a waiver under paragraph
(1) shall not exceed 1 year, unless the Secretary determines
that an extension is necessary to protect public health or
well-being.
''(3) Waivers by states prohibited.--The Secretary may not
authorize any State to grant waivers under this subsection.
''(f) Inspections.--The facilities of any pharmacy or pharmacist
compounding drug products pursuant to a waiver under subsection (c),
(d), or (e) shall be subject to inspection under section 704 for
purposes of determining compliance with the provisions of this Act
applicable to such compounding.
''(g) Cancellation of Waiver.--
''(1) In general.--The Secretary shall publish notice at
least 30 days before cancelling a waiver under subsection (c),
(d), or (e).
''(2) Exception for public health and safety.--The
Secretary may cancel a waiver without regard to paragraph (1)
in order to prevent an adverse impact on public health or
safety.
''(h) Labeling.--The labeling of any drug product compounded
pursuant to subsection (a) shall include the following statement: 'This
drug has not been tested for safety and effectiveness and is not
approved by the FDA. Serious adverse reactions to this drug should be
reported to the pharmacy where it was received and the FDA at _____.'
The blank shall specify a phone number and a Web site, to be provided
by the Secretary for purposes of this subsection.
''(i) Reporting by Pharmacists and Physicians.--
''(1) Adverse event.--If a pharmacist or physician
compounding a drug product pursuant to this section becomes
aware of any adverse event associated with the use of such
product, not later than 10 calendar days after becoming so
aware, the pharmacist or physician shall report such adverse
event to the Secretary.
''(2) Information related to risk of injury or death.--If a
pharmacist or physician compounding a drug product pursuant to
this section becomes aware of information concerning any
bacteriological, fungal, or other contamination; any
significant chemical, physical, or other change; or any
deterioration of a compounded drug product that has already
been distributed by the pharmacist or physician, that could
cause serious injury or death, not later than 5 calendar days
after becoming so aware, the pharmacist or physician shall
report such information to the Secretary.
''(j) Regulations.--The Secretary shall promulgate regulations for
carrying out this section, which shall include the following:
''(1) The types of pharmacies and pharmacists specified
pursuant to subsection (d)(3).
''(2) The criteria and process for determining whether a
State may provide a waiver under subsection (d)(4).
''(3) The information specified under subsection (d)(5)(A).
''(4) The requirements applicable to different types of
pharmacies and pharmacists under subsection (d)(5).
''(5) The requirements for inspections under subsection
(f).
''(k) Definitions.--In this section:
''(1) The term 'copy of a commercially available drug
product' does not include a drug product in which there is a
change, made for an identified individual patient, which
produces for that patient a significant difference, as
determined by the prescribing practitioner, between the
compounded drug and the comparable commercially available drug
product.
''(2) The term 'compounding' does not include mixing,
reconstituting, or other such acts that are performed in
accordance with directions contained in approved labeling
provided by the product's manufacturer and other manufacturer
directions consistent with that labeling.''.
(b) Misbranding.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the
following:
''(bb) If it is a drug product compounded pursuant to section 503A
and its labeling does not include the statement required by section
503A(h).''.
(c) Conforming Amendment.--Section 704(a)(2)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(2)(A)) is amended by
inserting ''subject to section 503A,'' before ''pharmacies which
maintain establishments''.
(d) Regulations.--Not later than 1 year after the date of the
enactment of this Act, the Secretary shall promulgate final regulations
for carrying out the amendments made by subsections (a), (b), and (c).
(e) Effective Date.--The amendments made by subsections (a), (b),
and (c) shall take effect on the date that is 1 year after the date of
the enactment of this Act.

SEC. 3. REGISTRATION AND INSPECTION OF MANUFACTURERS COMPOUNDING DRUG
PRODUCTS.

(a) Registration.--Section 510(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(g)) is amended by adding at the end the
following: ''With respect to compounding drugs, the exemption in
paragraph (1) does not apply with respect to any pharmacy to the extent
to which the pharmacy is, in effect, manufacturing such drugs, as
determined by the Secretary, taking into consideration the extent to
which such pharmacy sells the drugs across State lines, the quantity of
the drugs sold, and any other factors determined appropriate by the
Secretary.''.
(b) Inspection.--Section 704(a)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374(a)(2)) is amended by adding at the end the
following flush text:
''With respect to compounding drugs, the exemption in
subparagraph (A) does not apply with respect to any pharmacy to
the extent to which the pharmacy is, in effect, manufacturing
such drugs, as determined by the Secretary, taking into
consideration the extent to which such pharmacy sells the drugs
across State lines, the quantity of the drugs sold, and any
other factors determined appropriate by the Secretary.''.
(c) Regulations.--Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
promulgate regulations for carrying out the amendments made by
subsections (a) and (b).
(d) Effective Date.--The amendment made by subsection (a) shall
take effect on the date that is 1 year after the date of the enactment
of this Act.
Answer:
Verifying Authority and Legality In Drug Compounding Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs.

Eliminates authority for compounding pharmacies to: (1) compound drugs before the receipt of a valid prescription order, or (2) compound any drug product that is a copy of a commercially available drug.

Requires the Secretary of Health and Human Services (HHS) to develop, maintain and transmit to the appropriate state agencies a list of drug products that should not be compounded, including: (1) drug products whose compounding is reasonably likely to cause an adverse effect on their safety or effectiveness; and (2) drug products that have been withdrawn or removed from the market because they have been found to be unsafe or not effective.

Authorizes the Secretary to waive the requirement that a drug product must be compounded for an individually identified patient based on a valid prescription order or similar notation if compounding the drug product is necessary to address a drug shortage, or to protect public health or well-being. Prohibits the Secretary from authorizing a state to grant such waivers.

Authorizes the Secretary to waive the requirement that a drug product must be compounded for an individually identified patient based on a valid prescription order or similar notation if the pharmacy or pharmacist: (1) submits a satisfactory application to the Secretary; and (2) agrees to comply with any condition or limitation specified by the Secretary. Makes a pharmacy or pharmacist required to be registered under the FFDCA as a drug producer ineligible for a waiver. Permits the Secretary to authorize a state to grant such waivers applicable to compounded drug products sold or dispensed within the state pursuant to a memorandum of understanding between the Secretary and the state.

Authorizes the Secretary to waive the prohibition against compounding any drug product that is a copy of a commercially available drug if it is necessary to protect public health or well-being. Prohibits the Secretary from authorizing a state to waive such prohibition.

Subjects the facilities of any pharmacy receiving a waiver under this Act to inspection to determine compliance with this Act.

Requires the Secretary to publish notice at least 30 days before cancelling a waiver, unless it is necessary to prevent an adverse impact on public health or safety.

Sets forth a required label statement for any drug compounded pursuant to this Act.

Requires a pharmacist or physician compounding a drug product to report any adverse event associated with the use of the product within a specified time frame.