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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (3)

Short Titles

Short Titles - House of Representatives

Short Titles as Introduced

VALID Compounding Act
Verifying Authority and Legality In Drug Compounding Act of 2013

Official Titles

Official Titles - House of Representatives

Official Title as Introduced

To amend the Federal Food, Drug, and Cosmetic Act to provide for the compounding of drug products.

Actions Overview (1)

Date Actions Overview
05/23/2013Introduced in House

All Actions (3)

Date All Actions
05/24/2013Referred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
05/23/2013Referred to the House Committee on Energy and Commerce.
Action By: House of Representatives
05/23/2013Introduced in House
Action By: House of Representatives

Cosponsors (4)

* = Original cosponsor
CosponsorDate Cosponsored
Rep. Slaughter, Louise McIntosh [D-NY-25]* 05/23/2013
Rep. Clay, Wm. Lacy [D-MO-1]* 05/23/2013
Rep. Rangel, Charles B. [D-NY-13]* 05/23/2013
Rep. Eshoo, Anna G. [D-CA-18] 06/12/2013

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Related Documents
House Energy and Commerce05/23/2013 Referred to
House Energy and Commerce Subcommittee on Health05/24/2013 Referred to

No related bill information was received for H.R.2186.

Latest Summary (1)

There is one summary for H.R.2186. View summaries

Shown Here:
Introduced in House (05/23/2013)

Verifying Authority and Legality In Drug Compounding Act of 2013 or VALID Compounding Act - Amends the Federal Food, Drug, and Cosmetic Act with respect to the regulation of compounding drugs.

Requires the Secretary of Health and Human Services (HHS) to develop and maintain a list of bulk substances from which drug products may be compounded that specifies any limitation on compounding of the substance and the particular medical need that is met by placing such substance on the list. Requires the Secretary to receive and consider petitions from any person identifying a substance that should be added to or removed from the list. Sets forth requirements for such petitions. Requires the Secretary also to develop and maintain a list of drug products that should not be compounded.

Allows a pharmacy to compound drugs which are not for an identified individual patient based on the receipt of a prescription order if the pharmacy registers with the Secretary and agrees to comply with any condition of operation or limitation of activity the Secretary specifies. Sets forth information that must be included in any such registration.

Authorizes the compounding of a drug that is a copy of a commercially available drug product if: (1) the drug is on the drug shortage list with notice given to the Secretary by the pharmacy, or (2) the drug product is necessary to protect public health and well-being. Requires the pharmacy to demonstrate to the Secretary that controls will be used that are comparable to elements required for safe use for a drug subject to a risk evaluation and mitigation strategy.

Requires the Secretary to establish standards, processes, and procedures for high-risk sterile compounding.

Establishes requirements related to inspections, labeling, and adverse event reporting for compounded drugs.

Requires the Secretary to assess an annual establishment fee from compounding pharmacies and a reinspection fee for any pharmacy subject to a reinspection in a fiscal year. Sets forth a methodology for setting such fees and requires reduced fees for small businesses (pharmacies with $1 million or less in annual sales).

States that the requirements of this Act do not preempt any non-federal requirement that is in addition to, and compatible with, such requirements.