The claims arrive as a group, years after the last dose.

General liability

Manufacturing and laboratory premises, plus injury to visitors, inspectors and contractors.

Without it — The form product liability attaches to, and the one named in every supply and distribution agreement.

Products liability

Injury from a compound, including claims brought long after the exposure.

Without it — The defining exposure of the sector, and the slowest to emerge.

Product recall and withdrawal

Regulated recalls, market withdrawals and the destruction that follows.

Without it — A recall in this sector is a regulatory process with a fixed clock and real cost.

Clinical trial liability

The studies behind the submission.

Without it — No approval to run without it.

Contamination and cold chain

Batch contamination, and product spoiled in storage or transit.

Without it — A temperature excursion writes off a batch worth more than the shipment.

Directors and officers

Board exposure over disclosure, safety signals and regulatory communication.

Without it — The claims that follow a bad safety announcement are securities claims.

Group health and benefits

Manufacturing and QA staff working to a validated process.

Without it — A validated process depends on trained operators. Replacing one is a retraining and a requalification, not just a hire.

What does “long tail” mean in practice for us?

That a claim can be made many years after the product was taken, so the policy in force today may not be the one that answers. It makes two things matter more than the limit: whether coverage is occurrence-based or claims-made, and continuity. On a claims-made program, a gap between policies or a lapsed retroactive date can strand years of exposure with nothing behind it. Never let cover lapse between insurers, and keep the retroactive date when you move.

We compound rather than manufacture. Is that different?

Different market, same core exposure, and often harder to place. Compounding pharmacies sit between pharmacy professional liability and pharmaceutical products liability, and sterile compounding in particular draws close underwriting scrutiny after the contamination events that reshaped the sector. Expect questions about USP compliance, sterility testing, batch records and whether you compound for office use or on prescription: the answers determine which market will look at you.

Do our contract manufacturers cover us?

Their policy covers them. You should be an additional insured on it and you should still carry your own, because the marketing authorization holder is who patients and regulators pursue regardless of who ran the line. Relying on a CMO’s limits means relying on a limit shared with every other client they have, in a sector where one event affects a whole batch across all of them.