Description from Markey of Proposed Valid Compounding Act

The Verifying Authority and Legality In Drug (VALID) Compounding Act of 2012
The Verifying Authority and Legality In Drug (VALID) Compounding Act of 2012 builds on the
principles contained in the 1997 law that was later struck down, but without the provisions that
led to that legal outcome.
1. Preserves state regulatory authority for traditional small compounding pharmacy
activities. The VALID Compounding Act provides for an exemption from certain FDA
regulations if compounding pharmacies meet specific conditions, including:
• The drug must be compounded by a licensed pharmacist or physician for an identified
patient with a valid prescription;
• The drug must be compounded using safe and approved ingredients, and using good
manufacturing practices; and
• The drug cannot be a copy of a commercially-available drug.
2. Ensures that compounding pharmacies that are operating as drug manufacturers are
regulated by the FDA as drug manufacturers. The legislation requires compounding
pharmacies whose activities are classified by FDA as being more akin to drug manufacturing
(for example, because of the volumes of products they make) to register with the FDA as
manufacturers rather than pharmacies, and be subject to the same sorts of FDA inspection
authority as drug manufacturers are.
3. Allows some compounding pharmacies to request waivers to enable them to compound
drugs before the receipt of a valid prescription. The VALID Compounding Act requires
the FDA to define requirements (i.e. safety, testing, inspection, reporting or other
requirements) for types of compounding pharmacies that are not classified as drug
manufacturers, but that wish to compound drugs before receiving a valid prescription for an
identified patient. These types of compounding pharmacies could include hospital
pharmacies, community pharmacies that wish to make small batches of compounded drugs
for their regular customers, or compounding pharmacies that have small sterile compounding
facilities. The FDA also can delegate the authority for granting each type of waiver to state
regulatory authorities if the state authority has the resources to implement the waiver
program and oversee the facilities.
4. Allows the FDA to waive the requirement to compound drugs solely for individual
patients with valid prescriptions in the event of a drug shortage or to protect public
health. Waivers are for a period of one year, and extendable only if the drug shortage or
need to protect public health remains in effect.
5. Allows the FDA to waive the requirement to compound drugs only if they are not copies
of commercially-available drugs if doing so is necessary to protect public health or wellbeing.
Waivers are for a period of one year, and extendable only if the need to protect public
health or wellbeing remains in effect.
6. Increases transparency. FDA must create and maintain a “Do Not Compound” list of drugs
that are not safe or effective when compounded and make the list available to the public and
state regulators. The FDA is given clear authority to inspect any compounding pharmacy
that receives any waiver under the Act. Compounding pharmacies that become aware of
adverse reactions to compounded drugs or of potential safety problems with drugs they have
already distributed must report to the FDA. Compounded drugs must be labeled to ensure
that recipients are aware that FDA has not tested the drug for safety or effectiveness and to
provide a means to report serious adverse drug reactions.