1月19日，美国FDA进口禁令66-41（Import Alert 66-41）的名单上出现了 MayingLong Pharmaceutical Group Co., Ltd.,（备注是：The only product currently subject to the guidance outlined in this import alert is Licorice Coughing Liquid;Problem(s); Unapproved new drug）。说明马应龙药业此药品本应按照新药申请程序（NDA）经过批准后才能上市，但是该药在美国上市时，药品以“非处方药专论”路径申请了NDC号码：68511-460-01，未经FDA批准就上市了。
我们可以看出事件的关键是：
以美国非处方药专论上市，却不符合
美国FDA 《CPGM 7361.003 非处方药专论实施》说明了：符合美国非处方药专论（OTC Monograph）的，在成分、适应症、标签等方面，不需要经过美国FDA的审批就能上市，但需要符合cGMP要求。有偏离或不符合定稿专论的，在上市前需要FDA的审批。 法规 FDA CFR 341 对此类药物的成分、标签等内容作了具体要求。
Title 21 - Food and Drugs
PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
§ 341.18 Expectorant active ingredient.
The active ingredient of the product is guaifenesin when used within the dosage limits established in § 341.78(d).
§ 341.78 Labeling of expectorant drug products.
(d) Directions. The labeling of the product contains the following information under the heading “Directions” for products containing guaifenesin identified in § 341.18: Adults and children 12 years of age and over: oral dosage is 200 to 400 milligrams every 4 hours not to exceed 2,400 milligrams in 24 hours. Children 6 to under 12 years of age: oral dosage is 100 to 200 milligrams every 4 hours not to exceed 1,200 milligrams in 24 hours. Children 2 to under 6 years of age: oral dosage is 50 to 100 milligrams every 4 hours not to exceed 600 milligrams in 24 hours. Children under 2 years of age: consult a doctor.
§ 341.90 Professional labeling.
(d) The following labeling indication may be used for products containing guaifenesin identified in § 341.18 when used as a single ingredient product. “Helps loosen phlegm and thin bronchial secretions in patients with stable chronic bronchitis.”
