# 「複方製劑」指的是藥師或專業藥局為病人個別調配藥物。

*biotech · news · 2026-05-29 · MarketScreener*

## Key points

- FDA 已發布草案規定，禁止 503B 外包設施供應 GLP-1。
- 若該規則最終通過，503B 禁令預計將於 2027 年中期實施。
- 大多數 GLP-1 複方製劑仍在 503A 豁免下進行，該豁免較難監管。
- 複方 GLP-1 市場份額從 30% 降至 15%，明年可能再減半。

To begin, the term "compounding" refers to the personalized preparation of a medication for a patient by a pharmacist or a specialized pharmacy. This segment of the healthcare sector, particularly regarding GLP-1s (hormones that play a key role in regulating blood sugar and appetite), is significant for major pharmaceutical groups like Novo Nordisk as it represents direct competition. During shortages of branded GLP-1s, compounding pharmacies managed to capture a considerable market share in this space, although this has since receded slightly. Pharma giants such as Novo Nordisk and Eli Lilly viewed this as a risk and have intensified price competition to reclaim lost market share. A Jefferies Conference Call For this discussion, the American investment bank invited David Tolman, a consultant and former Vice President and General Counsel at Novartis Oncology. Tolman indicated that pressure from the US Food and Drug Administration (FDA) is intensifying, though it is merely accelerating a transition that was already underway. The FDA has issued a draft regulation that would effectively prohibit 503B outsourcing facilities (large-scale compounding sites) from supplying GLP-1s. However, implementation is not expected until mid-2027 if finalized, meaning short-term disruptions should remain limited. The majority of compounding currently occurs under the 503A exemption (traditional pharmacy preparations), which is more difficult to restrict. Nevertheless, regulators are increasingly questioning whether high-volume telemedicine models truly meet an individualized medical need. According to the Jefferies call, while compounded GLP-1 volumes have fallen from approximately 30% at the peak of the crisis to around 15% today, they could be halved again next year due to regulatory oversight, legal risk, and price competition from branded drugs. However, it is unlikely that this market will disappear in the short term. Jefferies maintains its Hold rating on Novo Nordisk shares, with a target price of DKK 270.

**Companies:** Novo Nordisk, Eli Lilly
**Countries:** United States, Denmark

[Read the full story on MarketScreener](https://www.marketscreener.com/news/jefferies-examines-glp-1-compounding-maintains-hold-rating-on-novo-nordisk-ce7f5ddbdf8df020)

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