One Page Summary of Verifying Authority and Legality in Drug Valid Compounding Act of 2013

The Verifying Authority and Legality In Drug (VALID) Compounding Act of 2013
Rep. Edward J. Markey
The Verifying Authority and Legality In Drug (VALID) Compounding Act of 2013 maintains
State authority for traditional compounding activities, while giving sole authority to the FDA in
regulating interstate commerce and pharmacies engaging in high-risk sterile compounding.
1. Provides the FDA with sole regulatory authority over compounding pharmacies that
engage in interstate commerce and high-risk sterile compounding without or in advance
of a prescription. High risk sterile compounding includes making sterile drug products from
non-sterile ingredients or devices, an activity that many States have neither the expertise nor
resources to oversee.
2. Preserves State regulatory authority for traditional small compounding pharmacies.
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 prescription for the drug.
• The drug must be compounded using safe and approved ingredients and practices.
• The drug cannot be a copy of a commercially-available drug, except in cases of a drug
shortage.
3. Allows compounding pharmacies to compound drugs before receiving prescriptions for
the drug provided that they register with the FDA and meet specified safety standards,
and allows capable State regulators to oversee these pharmacies. 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 wish to
compound drugs before or without 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 can enter into a memorandum of understanding with State regulatory boards that
demonstrate that they have the resources and ability to oversee and enforce safety
requirements for these pharmacies.
4. Increases communication between the States and federal government. In addition to a
formalized memorandum of understanding between the FDA and State regulators, the
VALID Act also requires the FDA to share any information gathered during inspection of a
compounding pharmacy with the State where the pharmacy is located and any States the
pharmacy ships products to, and requires FDA to share its lists of drugs that cannot be
compounded and bulk ingredients that can be used to compound drugs, with State regulators.
5. Increases transparency to patients and consumers. Compounded drugs must be labeled to
ensure that recipients are aware that they are receiving a compounded drug and to provide a
means to report serious adverse drug reactions. Pharmacies that are made aware of serious
adverse events are also required to report that information to the FDA. The VALID act also
creates a petition process allowing the public to submit to the FDA drugs that should or
should not be compounded because of a public health need or risk.