淡水錦元棉被店

(〃 ̄ ̄ ̄ ̄(エ) ̄ ̄ ̄ ̄)大丈夫じゃない、問題だ( ̄ ̄ ̄ ̄(エ) ̄ ̄ ̄ ̄〃) 日本フレンドを見えるのかた(/ω\)ありがとうカニ

2018年12月31日 星期一

弟殺害の朱美容疑者 父親殺しで再逮捕 「精神ほぼ崩壊」と日記に綴る(餌やり猫愛誤の子供は殺人鬼に育つ)(トキソプラズマ)(弓形蟲感染症)


弟殺害の朱美容疑者 父親殺しで再逮捕 「精神ほぼ崩壊」と日記に綴る(餌やり猫愛誤の子供は殺人鬼に育つ)(トキソプラズマ)(弓形蟲感染症)



 

 


大阪で今年3月、練炭自殺を装って実弟を殺害したとして殺人罪で起訴された水道工事会社社長、足立朱美容疑者(44)は10月17日、今年6月に父親(67)も殺害していた疑いで大阪府警に殺人容疑で再逮捕された

 本誌は朱美容疑者が実弟を殺害した容疑で逮捕されるまでの間、偽装工作のため、綴っていた「練炭日記」の詳細を報じた。そこには、父親の殺害についても記されていた。

【公開】朱美被告の肉筆「練炭殺人日記と遺書」はこちら

 朱美容疑者の父親は、実弟が殺害される2カ月前の1月に甘酒を飲んだ直後に低血糖状態で倒れ、意識不明の重体で病院搬送されたが6月に死亡した。

 朱美容疑者は、実弟が遺体となって発見された今年3月28日の「日記」で<弟のカバンの中身から父親のインスリンの注射が出てきた>と綴っていた。

 朱美容疑者は実弟のカバンから注射器が発見されたことから父親の死に実弟が関与していると主張したかったのでないかとみられる。

 また朱美容疑者は「日記」で、実弟と父親の関係について、今年5月8日と日付が入ったページに<父が貸した1000万円を返してもらう><弟名義にした父親の土地(奈良)の名義変更>など記している。

 そして、朱美容疑者の「日記」には、入院中の父親について<父親転院の為、手続き等に追われる>と書いている。



そして、5月11日の日記では<父親の転院や精神的に参っている><私の精神もほぼ崩壊している>と朱美容疑者は綴っている。

 5月24日の「日記」ではさらに<父親が今週末あたり、危ないと言われている><一家心中を考えた>。

 朱美容疑者は実弟と父親の殺害について容疑を現在も否認しているという。

 日記には<虚偽申告罪で告訴する!!>と訴え、父親が亡くなれば、実弟の妻などに「遺産」が渡ると主張している。だが、朱美容疑者が実弟の殺人容疑で逮捕、起訴されたのは、今年3月。その3カ月後に死亡した父親に対する殺害容疑での再逮捕となった。

「朱美容疑者は調べに対し、ほとんど黙秘。父親の死因は低血糖によるものだが、そのきっかけとなったのは、インシュリン入りの甘酒を飲んだことだ。甘酒に混入できたのは朱美容疑者しかいないという”消去法”の立証に全力を尽くした。父親は病院搬送される前から朱美容疑者が自宅に来ると体調を崩すことがあり周辺に『朱美に気をつけんとあかん』と話していた」(捜査関係者)

 朱美容疑者は、自身で綴っていたブログに尊敬する人として、父親を挙げている。一方で、ブログには「やいやい言う父親と毎日喧嘩」と不仲な内容もある朱美容疑者の実弟、父親に対する殺害動機が明らかになる日はくるのだろうか。(今西憲之)




https://dot.asahi.com/dot/2018101600012.html?page=1


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練炭自殺装い弟殺害 両親も狙う?44歳女社長の異様な「デスノート」



練炭自殺を装い、実の弟を殺害したとして、大阪府警捜査1課に20日、殺人容疑で逮捕された水道工事会社社長の足立朱美容疑者(44)。会社経営を巡る骨肉の争いで親まで狙うなど朱美容疑者が描いた異様な“デスノート”の全貌が明らかになってきた。


【写真】足立朱美容疑者

 朱美容疑者が殺害したのは弟の聖光さん(40)だ。2人はもともと父親が経営していた水道工事会社で働き、明美容疑者が父の後を継いで社長になり、聖光さんは別会社を立ち上げたという。

 しかし、2人の知人はこういう。

「聖光さんの方が受注が好調でいつしか”本家”の朱美容疑者の会社の業績を上回るようになった」

 いつしか聖光さんの会社は、仕事があふれて、朱美容疑者の「本家」の会社に仕事をまわす、逆転現象が起こっていたという。

 そんな中、今年3月27日に事件は起こった。 聖光さんが堺市の実家のトイレで「練炭自殺」をしているのが発見されたのだ。

 当初、大阪府警も「自殺」として処理していた。 だが、さまざまな不審な点が浮かび上がった。

 水道工事会社の創業者である姉弟の母親も聖光さんが実家で亡くなった時、昏睡状態になっていたのだ。

「母親は回復した後、『朱美容疑者に抹茶オーレを勧められて飲んだら意識がなくなった』と話しています」(捜査関係者)

 聖光さんの「自殺」は事件性が高いと大阪府警は捜査に乗り出した。

 すると、今年1月に糖尿病の持病を持つ父親が朱美容疑者の作った甘酒を飲んだ際、2度も緊急搬送されていたことがわかった。

 父親は、その後低血糖の症状を発症し、植物状態になっているという。


 そんな背景もあり、聖光さんの妻が「自殺なんてありえない」と訴え、殺人事件での捜査を警察に強く求めた。

「すでに聖光さんは火葬していたが、検体を保存していたことで調べることができました。すると、聖光さんの検体から睡眠薬が検出された。その成分を調べると、朱美容疑者の処方されていた薬と一致した」(前出の捜査関係者)


また、練炭の着火剤がトイレの外にあったこと、燃えカスがトイレに残っていないなど不自然な点がいくつも明らかになった。

「朱美容疑者は『これが弟の遺書だ』と周囲に示していたが、その遺書は朱美容疑者のパソコンで作成された可能性が高いことがわかった。また聖光さんはパソコンが扱えないことも判明。そして、フリーライターが取材、執筆をしたとされる怪文書が、今年4月に周辺にまかれたが、これも朱美容疑者のパソコンで作成されていたこともわかった。おまけに、朱美容疑者がスマホで、練炭自殺などのキーワード検索していたことも判明。そこから、練炭自殺の自殺を偽装したのではという疑いが固まった」(前出・捜査関係者)

 怪文書などの影響で噂はマスコミに広まり、朱美容疑者への疑念が深まっていた。その間、朱美容疑者は「冤罪はこうして作られるんだ」「弟は自殺以外ありえない」となどとマスコミに主張。疑惑の渦中にいる中、大阪府警に逮捕された。朱美容疑者は今も容疑については否認し続けているという。(今西憲之)


https://dot.asahi.com/wa/2018062200024.html?page=1


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弟を「練炭殺害」した姉の実父も怪死 自身のブログでは動物殺処分への怒り綴る(餌やり猫愛誤の子供は殺人鬼に育つ)(弓形蟲感染症)


 https://dot.asahi.com/dot/2018070100014.html?page=1

 https://headlines.yahoo.co.jp/article?a=20180701-00000014-sasahi-soci

 

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 練炭自殺装い弟殺害 44歳の姉に離婚トラブルで元夫の定期に大麻入れた過去

https://dot.asahi.com/wa/2018062400003.html?page=1


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弟を殺害で起訴 朱美被告が綴った「練炭殺人日記」全文入手


https://dot.asahi.com/wa/2018071100098.html?page=1

 

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人と動物の共通感染症に関するガイドライン
https://www.env.go.jp/nature/dobutsu/aigo/2_data/pamph/infection/guideline.pdf

トキソプラズマが人の脳を操る仕組み


http://natgeo.nikkeibp.co.jp/nng/article/news/14/7449/


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起業したい人は猫のウ●コ食べればできるかも!(良い子は真似しないように、危険です)

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[大阪]野良猫への餌やりから口論となり、同じマンションに住む男性をカッターで切りつけ。(2015/06)
[東京]野良猫に餌をあげ、隣人に注意された事に怒り果物ナイフで切りつけ。(2015/05)
[福岡]「野良猫に餌をやるな」と注意されて激怒し、57歳男性の顔面を殴る。(2014/11)
[静岡]よく公園で餌やりしていた犯人が、市主導で野良猫駆除を行っていた男性の胸倉を掴みカッターで脅す。(2011/03)
[船橋]女性から野良猫の餌やりを注意され、その帰宅を待ち伏せして包丁で刺殺。(2009/08)
[川崎]アパートの大家に餌やりを注意され逆上、大家を刺殺し義理の娘にも重症を負わせる。(2008/06)
[大阪]猫被害の苦情を言いに来たアパートの隣人を包丁で刺す。(2007/07)
[尼崎]猫の餌付けに苦情を言った人の部屋へ包丁を持って押し込み乱闘に。(2005/04)



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猫オタのロリコン勝又拓哉が2005年栃木県今市市で下校途中の7歳の女児を車で拉致して 
わいせつ行為をしたあとに胸をメッタ刺しにして殺害して雑木林に遺棄した残虐な事件 
勝又拓哉の飼っていた希少種の猫の毛が女児の遺体の付着していたことが逮捕の決め手 

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猫オタが起こした猟奇殺人事件「神戸小1女児バラバラ殺害事件」 

猫オタのロリコン君野康弘が2014.年に神戸市長田区で6歳の女児を家に連れ込んで 
殺害してわいせつ行為をした後に遺体をバラバラにしてビニール袋に入れて遺棄した残虐な事件 
君野康弘は飼ってる猫を餌に猫好き女児を家に連れ込んでいた 勝又被告、控訴審も有罪 今市事件で東京高裁 
-------------------------------------------------------
2005年12月、日光市(旧今市市)大沢小1年だった吉田有希ちゃん=当時(7)=が殺害された 
今市事件で、殺人罪に問われた鹿沼市西沢町、無職勝又拓哉被告(36)の控訴審判決公判が 
3日午前、東京高裁で開かれた。藤井敏明裁判長は、無期懲役を言い渡した一審宇都宮地裁の 
裁判員裁判判決を破棄したが、被告に無期懲役を言い渡した。 

https://headlines.yahoo.co.jp/hl?a=20180803-03057321-soon-l09




猫27匹餌代欲しさに空き巣27件「猫にほおずり至福」 容疑の52歳男逮捕 4年前も御用(トキソプラズマ)(弓形蟲感染症)


猫27匹餌代欲しさに空き巣27件「猫にほおずり至福」 容疑の52歳男逮捕 4年前も御用(トキソプラズマ)(弓形蟲感染症)


ネコの餌代欲しさに空き巣を繰り返したとして、大阪府警岸和田署は12日、住居侵入と窃盗の疑いで大阪府和泉市池田下町の無職、出水衛(でみず・まもる)容疑者(52)を逮捕、送検し、27件の被害(総額約310万円相当)を裏付けて捜査を終えたと発表した。「野良猫を放っておけず、27匹飼っていた。キャットフードや魚を買う目的で盗みをした」と容疑を認めている
 捜査関係者によると、出水容疑者は平成25年にもネコの餌代欲しさに空き巣をしたとして府警に逮捕されていた。当時は「野良猫が集まる場所を順番に回っていた。ネコにほおずりするのが至福の時間だった」などと供述していた。
 今回の送検容疑は昨年11月、同府岸和田市の70代男性方に侵入し、現金14万円を盗むなど、同市や和泉市を中心に無施錠の玄関や窓から侵入する手口で、4年以上にわたって盗みを繰り返したとしている。
 同署によると、被害に遭った民家の防犯カメラ映像から出水容疑者の関与が浮上したという。
































https://www.sankei.com/west/news/170412/wst1704120065-n1.html



-------------------------------------------------------


 
人と動物の共通感染症に関するガイドライン
https://www.env.go.jp/nature/dobutsu/aigo/2_data/pamph/infection/guideline.pdf

トキソプラズマが人の脳を操る仕組み


http://natgeo.nikkeibp.co.jp/nng/article/news/14/7449/


-----------------------------------------------------------------------------

起業したい人は猫のウ●コ食べればできるかも!(良い子は真似しないように、危険です)

-----------------------------------------------------------------------------

[大阪]野良猫への餌やりから口論となり、同じマンションに住む男性をカッターで切りつけ。(2015/06)
[東京]野良猫に餌をあげ、隣人に注意された事に怒り果物ナイフで切りつけ。(2015/05)
[福岡]「野良猫に餌をやるな」と注意されて激怒し、57歳男性の顔面を殴る。(2014/11)
[静岡]よく公園で餌やりしていた犯人が、市主導で野良猫駆除を行っていた男性の胸倉を掴みカッターで脅す。(2011/03)
[船橋]女性から野良猫の餌やりを注意され、その帰宅を待ち伏せして包丁で刺殺。(2009/08)
[川崎]アパートの大家に餌やりを注意され逆上、大家を刺殺し義理の娘にも重症を負わせる。(2008/06)
[大阪]猫被害の苦情を言いに来たアパートの隣人を包丁で刺す。(2007/07)
[尼崎]猫の餌付けに苦情を言った人の部屋へ包丁を持って押し込み乱闘に。(2005/04)



-------------------------------------------------------


猫オタのロリコン勝又拓哉が2005年栃木県今市市で下校途中の7歳の女児を車で拉致して 
わいせつ行為をしたあとに胸をメッタ刺しにして殺害して雑木林に遺棄した残虐な事件 
勝又拓哉の飼っていた希少種の猫の毛が女児の遺体の付着していたことが逮捕の決め手 

-------------------------------------------------------
猫オタが起こした猟奇殺人事件「神戸小1女児バラバラ殺害事件」 

猫オタのロリコン君野康弘が2014.年に神戸市長田区で6歳の女児を家に連れ込んで 
殺害してわいせつ行為をした後に遺体をバラバラにしてビニール袋に入れて遺棄した残虐な事件 
君野康弘は飼ってる猫を餌に猫好き女児を家に連れ込んでいた 勝又被告、控訴審も有罪 今市事件で東京高裁 
-------------------------------------------------------
2005年12月、日光市(旧今市市)大沢小1年だった吉田有希ちゃん=当時(7)=が殺害された 
今市事件で、殺人罪に問われた鹿沼市西沢町、無職勝又拓哉被告(36)の控訴審判決公判が 
3日午前、東京高裁で開かれた。藤井敏明裁判長は、無期懲役を言い渡した一審宇都宮地裁の 
裁判員裁判判決を破棄したが、被告に無期懲役を言い渡した。 

https://headlines.yahoo.co.jp/hl?a=20180803-03057321-soon-l09





How Your Cat Is Making You Crazy(トキソプラズマ)(弓形蟲感染症)


How Your Cat Is Making You Crazy

(トキソプラズマ)(弓形蟲感染症)


























































Jaroslav Flegr is no kook. And yet, for years, he suspected his mind had been taken over by parasites that had invaded his brain. So the prolific biologist took his science-fiction hunch into the lab. What he’s now discovering will startle you. Could tiny organisms carried by house cats be creeping into our brains, causing everything from car wrecks to schizophrenia?



No one would accuse Jaroslav Flegr of being a conformist. A self-described “sloppy dresser,” the 53-year-old Czech scientist has the contemplative air of someone habitually lost in thought, and his still-youthful, square-jawed face is framed by frizzy red hair that encircles his head like a ring of fire.
Certainly Flegr’s thinking is jarringly unconventional. Starting in the early 1990s, he began to suspect that a single-celled parasite in the protozoan family was subtly manipulating his personality, causing him to behave in strange, often self-destructive ways. And if it was messing with his mind, he reasoned, it was probably doing the same to others.
The parasite, which is excreted by cats in their feces, is called Toxoplasma gondii (T. gondii or Toxo for short) and is the microbe that causes toxoplasmosis—the reason pregnant women are told to avoid cats’ litter boxes. Since the 1920s, doctors have recognized that a woman who becomes infected during pregnancy can transmit the disease to the fetus, in some cases resulting in severe brain damage or death. T. gondii is also a major threat to people with weakened immunity: in the early days of the AIDS epidemic, before good antiretroviral drugs were developed, it was to blame for the dementia that afflicted many patients at the disease’s end stage. Healthy children and adults, however, usually experience nothing worse than brief flu-like symptoms before quickly fighting off the protozoan, which thereafter lies dormant inside brain cells—or at least that’s the standard medical wisdom.



But if Flegr is right, the “latent” parasite may be quietly tweaking the connections between our neurons, changing our response to frightening situations, our trust in others, how outgoing we are, and even our preference for certain scents. And that’s not all. He also believes that the organism contributes to car crashes, suicides, and mental disorders such as schizophrenia. When you add up all the different ways it can harm us, says Flegr, Toxoplasma might even kill as many people as malaria, or at least a million people a year.”

An evolutionary biologist at Charles University in Prague, Flegr has pursued this theory for decades in relative obscurity. Because he struggles with English and is not much of a conversationalist even in his native tongue, he rarely travels to scientific conferences. That “may be one of the reasons my theory is not better known,” he says. And, he believes, his views may invite deep-seated opposition. “There is strong psychological resistance to the possibility that human behavior can be influenced by some stupid parasite,” he says. “Nobody likes to feel like a puppet. Reviewers [of my scientific papers] may have been offended.” Another more obvious reason for resistance, of course, is that Flegr’s notions sound an awful lot like fringe science, right up there with UFO sightings and claims of dolphins telepathically communicating with humans.

But after years of being ignored or discounted, Flegr is starting to gain respectability. Psychedelic as his claims may sound, many researchers, including such big names in neuroscience as Stanford’s Robert Sapolsky, think he could well be onto something. Flegr’s “studies are well conducted, and I can see no reason to doubt them,” Sapolsky tells me. Indeed, recent findings from Sapolsky’s lab and British groups suggest that the parasite is capable of extraordinary shenanigans. T. gondii, reports Sapolsky, can turn a rat’s strong innate aversion to cats into an attraction, luring it into the jaws of its No. 1 predator. Even more amazing is how it does this: the organism rewires circuits in parts of the brain that deal with such primal emotions as fear, anxiety, and sexual arousal. “Overall,” says Sapolsky, “this is wild, bizarre neurobiology.” Another academic heavyweight who takes Flegr seriously is the schizophrenia expert E. Fuller Torrey, director of the Stanley Medical Research Institute, in Maryland. “I admire Jaroslav for doing [this research],” he says. “It’s obviously not politically correct, in the sense that not many labs are doing it. He’s done it mostly on his own, with very little support. I think it bears looking at. I find it completely credible.”
What’s more, many experts think T. gondii may be far from the only microscopic puppeteer capable of pulling our strings. “My guess is that there are scads more examples of this going on in mammals, with parasites we’ve never even heard of,” says Sapolsky.



Familiar to most of us, of course, is the rabies virus. On the verge of killing a dog, bat, or other warm-blooded host, it stirs the animal into a rage while simultaneously migrating from the nervous system to the creature’s saliva, ensuring that when the host bites, the virus will live on in a new carrier. But aside from rabies, stories of parasites commandeering the behavior of large-brained mammals are rare. The far more common victims of parasitic mind control—at least the ones we know about—are fish, crustaceans, and legions of insects, according to Janice Moore, a behavioral biologist at Colorado State University. “Flies, ants, caterpillars, wasps, you name it—there are truckloads of them behaving weirdly as a result of parasites,” she says.

Consider Polysphincta gutfreundi, a parasitic wasp that grabs hold of an orb spider and attaches a tiny egg to its belly. A wormlike larva emerges from the egg, and then releases chemicals that prompt the spider to abandon weaving its familiar spiral web and instead spin its silk thread into a special pattern that will hold the cocoon in which the larva matures. The “possessed” spider even crochets a specific geometric design in the net, camouflaging the cocoon from the wasp’s predators.
Flegr himself traces his life’s work to another master of mind control. Almost 30 years ago, as he was reading a book by the British evolutionary biologist Richard Dawkins, Flegr was captivated by a passage describing how a flatworm turns an ant into its slave by invading the ant’s nervous system. A drop in temperature normally causes ants to head underground, but the infected insect instead climbs to the top of a blade of grass and clamps down on it, becoming easy prey for a grazing sheep. “Its mandibles actually become locked in that position, so there’s nothing the ant can do except hang there in the air,” says Flegr. The sheep grazes on the grass and eats the ant; the worm gains entrance into the ungulate’s gut, which is exactly where it needs to be in order to complete—as the Lion King song goes—the circle of life. “It was the first I learned about this kind of manipulation, so it made a big impression on me,” Flegr says.

After he read the book, Flegr began to make a connection that, he readily admits, others might find crazy: his behavior, he noticed, shared similarities with that of the reckless ant. For example, he says, he thought nothing of crossing the street in the middle of dense traffic, “and if cars honked at me, I didn’t jump out of the way.” He also made no effort to hide his scorn for the Communists who ruled Czechoslovakia for most of his early adulthood. “It was very risky to openly speak your mind at that time,” he says. “I was lucky I wasn’t imprisoned.” And during a research stint in eastern Turkey, when the strife-torn region frequently erupted in gunfire, he recalls being “very calm.” In contrast, he says, “my colleagues were terrified. I wondered what was wrong with myself.”


His bewilderment continued until 1990, when he joined the biology faculty of Charles University. As it happened, the 650-year-old institution had long been a world leader in documenting the health effects of T. gondii, as well as developing methods for detecting the parasite. In fact, just as Flegr was arriving, his colleagues were searching for infected individuals on whom to test their improved diagnostic kits, which is how he came to be asked one day to roll up his sleeve and donate blood. He discovered that he had the parasite—and just possibly, he thought, the key to his baffling self-destructive streak.

He delved into T. gondii’s life cycle. After an infected cat defecates, Flegr learned, the parasite is typically picked up from the soil by scavenging or grazing animals—notably rodents, pigs, and cattle—all of which then harbor it in their brain and other body tissues. Humans, on the other hand, are exposed not only by coming into contact with litter boxes, but also, he found, by drinking water contaminated with cat feces, eating unwashed vegetables, or, especially in Europe, by consuming raw or undercooked meat. Hence the French, according to Flegr, with their love of steak prepared saignant—literally, “bleeding”—can have infection rates as high as 55 percent. (Americans will be happy to hear that the parasite resides in far fewer of them, though a still substantial portion: 10 to 20 percent.) Once inside an animal or human host, the parasite then needs to get back into the cat, the only place where it can sexually reproduce—and this is when, Flegr believed, behavioral manipulation might come into play.


Researchers had already observed a few peculiarities about rodents with T. gondii that bolstered Flegr’s theory. The infected rodents were much more active in running wheels than uninfected rodents were, suggesting that they would be more-attractive targets for cats, which are drawn to fast-moving objects. They also were less wary of predators in exposed spaces. Little, however, was known about how the latent infection might influence humans, because we and other large mammals were widely presumed to be accidental hosts, or, as scientists are fond of putting it, a “dead end” for the parasite. But even if we were never part of the parasite’s life cycle, Flegr reasoned, mammals from mouse to man share the vast majority of their genes, so we might, in a case of mistaken identity, still be vulnerable to manipulations by the parasite.

In the Soviet-stunted economy, animal studies were way beyond Flegr’s research budget. But fortunately for him, 30 to 40 percent of Czechs had the latent form of the disease, so plenty of students were available “to serve as very cheap experimental animals.” He began by giving them and their parasite-free peers standardized personality tests—an inexpensive, if somewhat crude, method of measuring differences between the groups. In addition, he used a computer-based test to assess the reaction times of participants, who were instructed to press a button as soon as a white square popped up anywhere against the dark background of the monitor.




The subjects who tested positive for the parasite had significantly delayed reaction times. Flegr was especially surprised to learn, though, that the protozoan appeared to cause many sex-specific changes in personality. Compared with uninfected men, males who had the parasite were more introverted, suspicious, oblivious to other people’s opinions of them, and inclined to disregard rules. Infected women, on the other hand, presented in exactly the opposite way: they were more outgoing, trusting, image-conscious, and rule-abiding than uninfected women.

The findings were so bizarre that Flegr initially assumed his data must be flawed. So he tested other groups—civilian and military populations. Again, the same results. Then, in search of more corroborating evidence, he brought subjects in for further observation and a battery of tests, in which they were rated by someone ignorant of their infection status. To assess whether participants valued the opinions of others, the rater judged how well dressed they appeared to be. As a measure of gregariousness, participants were asked about the number of friends they’d interacted with over the past two weeks. To test whether they were prone to being suspicious, they were asked, among other things, to drink an unidentified liquid.

The results meshed well with the questionnaire findings. Compared with uninfected people of the same sex, infected men were more likely to wear rumpled old clothes; infected women tended to be more meticulously attired, many showing up for the study in expensive, designer-brand clothing. Infected men tended to have fewer friends, while infected women tended to have more. And when it came to downing the mystery fluid, reports Flegr, “the infected males were much more hesitant than uninfected men. They wanted to know why they had to do it. Would it harm them?” In contrast, the infected women were the most trusting of all subjects. “They just did what they were told,” he says.

Why men and women reacted so differently to the parasite still mystified him. After consulting the psychological literature, he started to suspect that heightened anxiety might be the common denominator underlying their responses. When under emotional strain, he read, women seek solace through social bonding and nurturing. In the lingo of psychologists, they’re inclined to “tend and befriend.” Anxious men, on the other hand, typically respond by withdrawing and becoming hostile or antisocial. Perhaps he was looking at flip sides of the same coin.
Closer inspection of Flegr’s reaction-time results revealed that infected subjects became less attentive and slowed down a minute or so into the test. This suggested to him that Toxoplasma might have an adverse impact on driving, where constant vigilance and fast reflexes are critical. He launched two major epidemiological studies in the Czech Republic, one of men and women in the general population and another of mostly male drivers in the military. Those who tested positive for the parasite, both studies showed, were about two and a half times as likely to be in a traffic accident as their uninfected peers.



When I met Flegr for the first time, last September, at his office on the third floor of Charles University’s Biological Sciences building, I was expecting something of a wild man. But once you get past the riotous red hair, his style is understated. Thin and slight of build, he’s soft-spoken, precise with his facts, and—true to his Toxo status—clad in old sneakers, faded bell-bottom jeans, and a loose-fitting button-up shirt. As our conversation proceeds, I discover that his latest findings have become—to quote Alice in Wonderland—“curiouser and curiouser,” which may explain why his forehead has the deep ruts of a chronic worrier, or someone perpetually perplexed.

He’s published some data, he tells me, that suggest infected males might have elevated testosterone levels. Possibly for that reason, women shown photos of these men rate them as more masculine than pictures of uninfected men. “I want to investigate this more closely to see if it’s true,” he says. “Also, it could be women find infected men more attractive. That’s something else we hope to test.”
Meanwhile, two Turkish studies have replicated his studies linking Toxoplasma to traffic accidents. With up to one-third of the world infected with the parasite, Flegr now calculates that T. gondii is a likely factor in several hundred thousand road deaths each year. In addition, reanalysis of his personality-questionnaire data revealed that, just like him, many other people who have the latent infection feel intrepid in dangerous situations. “Maybe,” he says, “that’s another reason they get into traffic accidents. They don’t have a normal fear response.”

It’s almost impossible to hear about Flegr’s research without wondering whether you’re infected—especially if, like me, you’re a cat owner, favor very rare meat, and identify even a little bit with your Toxo sex stereotype. So before coming to Prague, I’d gotten tested for the parasite, but I didn’t yet know the results. It seemed a good time to see what his intuition would tell me. “Can you guess from observing someone whether they have the parasite—myself, for example?,” I ask.
“No,” he says, “the parasite’s effects on personality are very subtle.” If, as a woman, you were introverted before being infected, he says, the parasite won’t turn you into a raving extrovert. It might just make you a little less introverted. “I’m very typical of Toxoplasma males,” he continues. “But I don’t know whether my personality traits have anything to do with the infection. It’s impossible to say for any one individual. You usually need about 50 people who are infected and 50 who are not, in order to see a statistically significant difference. The vast majority of people will have no idea they’re infected.”

Still, he concedes, the parasite could be very bad news for a small percentage of people—and not just those who might be at greater risk for car accidents. Many schizophrenia patients show shrinkage in parts of their cerebral cortex, and Flegr thinks the protozoan may be to blame for that. He hands me a recently published paper on the topic that he co-authored with colleagues at Charles University, including a psychiatrist named Jiri Horacek. Twelve of 44 schizophrenia patients who underwent MRI scans, the team found, had reduced gray matter in the brain—and the decrease occurred almost exclusively in those who tested positive for T. gondii. After reading the abstract, I must look stunned, because Flegr smiles and says, “Jiri had the same response. I don’t think he believed it could be true.” When I later speak with Horacek, he admits to having been skeptical about Flegr’s theory at the outset. When they merged the MRI results with the infection data, however, he went from being a doubter to being a believer. “I was amazed at how pronounced the effect was,” he says. “To me that suggests the parasite may trigger schizophrenia in genetically susceptible people.”




One might be tempted to dismiss the bulk of Flegr’s work as hokum—the fanciful imaginings of a lone, eccentric scholar—were it not for the pioneering research of Joanne Webster, a parasitologist at Imperial College London. Just as Flegr was embarking on his human trials, Webster, then a freshly minted Ph.D., was launching studies of Toxo-infected rodents, reasoning, just as Flegr did, that as hosts of the parasite, they would be likely targets for behavioral manipulation.

She quickly confirmed, as previous researchers had shown, that infected rats were more active and less cautious in areas where predators lurk. But then, in a simple, elegant experiment, she and her colleagues demonstrated that the parasite did something much more remarkable. They treated one corner of each rat’s enclosure with the animal’s own odor, a second with water, a third with cat urine, and the last corner with the urine of a rabbit, a creature that does not prey on rodents. “We thought the parasite might reduce the rats’ aversion to cat odor,” she told me. “Not only did it do that, but it actually increased their attraction. They spent more time in the cat-treated areas.” She and other scientists repeated the experiment with the urine of dogs and minks, which also prey on rodents. The effect was so specific to cat urine, she says, that “we call it ‘fatal feline attraction.’”

She began tagging the parasite with fluorescent markers and tracking its progress in the rats’ bodies. Given the surgically precise way the microbe alters behavior, Webster anticipated that it would end up in localized regions of the brain. But the results defied expectations. “We were quite surprised to find the cysts—the parasite’s dormant form—all over the brain in what otherwise appeared to be a happy, healthy rat,” she says. Nonetheless, the cysts were most abundant in a part of the brain that deals with pleasure (in human terms, we’re talking sex, drugs, and rock and roll) and in another area that’s involved in fear and anxiety (post-traumatic stress disorder affects this region of the brain). Perhaps, she thought, T. gondii uses a scattershot approach, disseminating cysts far and wide, enabling a few of them to zero in on the right targets.

To gain more clarity on the matter, she sought the aid of the parasitologist Glenn McConkey, whose team at the University of Leeds was probing the protozoan’s genome for signs of what it might be doing. The approach brought to light a striking talent of the parasite: it has two genes that allow it to crank up production of the neurotransmitter dopamine in the host brain. “We never cease to be amazed by the sophistication of these parasites,” Webster says.


Their findings, reported last summer, created immediate buzz. Dopamine is a critical signaling molecule involved in fear, pleasure, and attention. Furthermore, the neurotransmitter is known to be jacked up in people with schizophrenia—another one of those strange observations about the disease, like its tendency to erode gray matter, that have long puzzled medical researchers. Antipsychotic medicine designed to quell schizophrenic delusions apparently blocks the action of dopamine, which had suggested to Webster that what it might really be doing is thwarting the parasite. Scientists had already shown that adding the medicine to a petri dish where T. gondii is happily dividing will stunt the organism’s growth. So Webster decided to feed the antipsychotic drug to newly infected rats to see how they reacted. Lo and behold, they didn’t develop fatal feline attraction. Suddenly, attributing behavioral changes to the microbe seemed much more plausible.




As the scientific community digested the British team’s dopamine discoveries, Robert Sapolsky’s lab at Stanford announced still more attention-grabbing news. The neuroscientist and his colleagues found that T. gondii disconnects fear circuits in the brain, which might help to explain why infected rats lose their aversion to cat odor. Just as startling, reports Sapolsky, the parasite simultaneously is “able to hijack some of the circuitry related to sexual arousal” in the male rat—probably, he theorizes, by boosting dopamine levels in the reward-processing part of the brain. So when the animal catches a whiff of cat scent, the fear center fails to fully light up, as it would in a normal rat, and instead the area governing sexual pleasure begins to glow. “In other words,” he says, “Toxo makes cat odor smell sexy to male rats.”

The neurobiologist Ajai Vyas, after working with Sapolsky on this study as a postdoctoral student, decided to inspect infected rats’ testicles for signs of cysts. Sure enough, he found them there—as well as in the animals’ semen. And when the rat copulates, Vyas discovered, the protozoan moves into the female’s womb, typically infecting 60 percent of her pups, before traveling on up to her own brain—creating still more vehicles for ferrying the parasite back into the belly of a cat.


Could T. gondii be a sexually transmitted disease in humans too? “That’s what we hope to find out,” says Vyas, who now works at Nanyang Technological University, in Singapore. The researchers also discovered that infected male rats suddenly become much more attractive to females. “It’s a very strong effect,” says Vyas. “Seventy-five percent of the females would rather spend time with the infected male.”


After I return from Prague, Flegr informs me that he’s just had a paper accepted for publication that, he claims, “proves fatal feline attraction in humans.” By that he means that infected men like the smell of cat pee—or at least they rank its scent much more favorably than uninfected men do. Displaying the characteristic sex differences that define many Toxo traits, infected women have the reverse response, ranking the scent even more offensive than do women free of the parasite. The sniff test was done blind and also included urine collected from a dog, horse, hyena, and tiger. Infection did not affect how subjects rated these other samples.


“Is it possible cat urine may be an aphrodisiac for infected men?,” I ask. “Yes. It’s possible. Why not?” says Flegr. I think he’s smiling at the other end of the phone line, but I’m not sure, which leaves me wondering whether I’ve stumbled onto a topic ripe for a Saturday Night Live skit, or a matter worthy of medical concern. When I ask Sapolsky about Flegr’s most recent research, he says the effects Flegr is reporting “are incredibly cool. However, I’m not too worried, in that the effects on humans are not gigantic. If you want to reduce serious car accidents, and you had to choose between curing people of Toxo infections versus getting people not to drive drunk or while texting, go for the latter in terms of impact.”


In fact, Sapolsky thinks that Toxo’s inventiveness might even offer us some benefits. If we can figure out how the parasite makes animals less fearful, he says, it might give us insights into how to devise treatments for people plagued by social-anxiety disorder, phobias, PTSD, and the like. “But frankly,” he adds, “this mostly falls into the ‘Get a load of this, can you believe what nature has come up with?’ category.”


Webster is more circumspect, if not downright troubled. “I don’t want to cause any panic,” she tells me. “In the vast majority of people, there will be no ill effects, and those who are affected will mostly demonstrate subtle shifts of behavior. But in a small number of cases, [Toxo infection] may be linked to schizophrenia and other disturbances associated with altered dopamine levels—for example, obsessive-compulsive disorder, attention-deficit hyperactivity disorder, and mood disorders. The rat may live two or three years, while humans can be infected for many decades, which is why we may be seeing these severe side effects in people. We should be cautious of dismissing such a prevalent parasite.”


The psychiatrist E. Fuller Torrey agrees—though he came to this viewpoint from a completely different angle than either Webster or Flegr. His opinion stems from decades of research into the root causes of schizophrenia. “Textbooks today still make silly statements that schizophrenia has always been around, it’s about the same incidence all over the world, and it’s existed since time immemorial,” he says. “The epidemiology literature contradicts that completely.” In fact, he says, schizophrenia did not rise in prevalence until the latter half of the 18th century, when for the first time people in Paris and London started keeping cats as pets. The so-called cat craze began among “poets and left-wing avant-garde Greenwich Village types,” says Torrey, but the trend spread rapidly—and coinciding with that development, the incidence of schizophrenia soared.


Since the 1950s, he notes, about 70 epidemiology studies have explored a link between schizophrenia and T. gondii. When he and his colleague Robert Yolken, a neurovirologist at Johns Hopkins University, surveyed a subset of these papers that met rigorous scientific standards, their conclusion complemented the Prague group’s discovery that schizophrenic patients with Toxo are missing gray matter in their brains. Torrey and Yolken found that the mental illness is two to three times as common in people who have the parasite as in controls from the same region.
Human-genome studies, both scientists believe, are also in keeping with that finding—and might explain why schizophrenia runs in families. The most replicated result from that line of investigation, they say, suggests that the genes most commonly associated with schizophrenia relate to the immune system and how it reacts to infectious agents. So in many cases where the disease appears to be hereditary, they theorize, what may in fact be passed down is an aberrant or deficient immune response to invaders like T. gondii.




Epstein-Barr virus, mumps, rubella, and other infectious agents, they point out, have also been linked to schizophrenia—and there are probably more as yet unidentified triggers, including many that have nothing to do with pathogens. But for now, they say, Toxo remains the strongest environmental factor implicated in the disorder. “If I had to guess,” says Torrey, “I’d say 75 percent of cases of schizophrenia are associated with infectious agents, and Toxo would be involved in a significant subset of those.”


Just as worrisome, says Torrey, the parasite may also increase the risk of suicide.
In a 2011 study of 20 European countries, the national suicide rate among women increased in direct proportion to the prevalence of the latent Toxo infection in each nation’s female population. According to Teodor Postolache, a psychiatrist and the director of the Mood and Anxiety Program at the University of Maryland School of Medicine, a flurry of other studies, several conducted by his own team, offers further support of T. gondii’s link to higher rates of suicidal behavior. These include investigations of general populations as well as groups made up of patients with bipolar disorder, severe depression, and schizophrenia, and in places as diverse as Turkey, Germany, and the Baltimore/Washington area. Exactly how the parasite may push vulnerable people over the edge is yet to be determined. Postolache theorizes that what disrupts mood and the ability to control violent impulses may not be the organism per se, but rather neurochemical changes associated with the body’s immune response to it. “As far-fetched as these ideas may sound,” says Postolache, “the American Foundation for Suicide Prevention was willing to put money behind this research.”


Given all the nasty science swirling around this parasite, is it time for cat lovers to switch their allegiance to other animals?
Even Flegr would advise against that. Indoor cats pose no threat, he says, because they don’t carry the parasite. As for outdoor cats, they shed the parasite for only three weeks of their life, typically when they’re young and have just begun hunting. During that brief period, Flegr simply recommends taking care to keep kitchen counters and tables wiped clean. (He practices what he preaches: he and his wife have two school-age children, and two outdoor cats that have free roam of their home.) Much more important for preventing exposure, he says, is to scrub vegetables thoroughly and avoid drinking water that has not been properly purified, especially in the developing world, where infection rates can reach 95 percent in some places. Also, he advises eating meat on the well-done side—or, if that’s not to your taste, freezing it before cooking, to kill the cysts.


As concerns about the latent infection mount, however, experts have begun thinking about more-aggressive steps to counter the parasite’s spread. Inoculating cats or livestock against T. gondii might be one way to interrupt its life cycle, offers Johns Hopkins’ Robert Yolken. Moving beyond prevention to treatment is a taller order. Once the parasite becomes deeply ensconced in brain cells, routing it out of the body is virtually impossible: the thick-walled cysts are impregnable to antibiotics. Because T. gondii and the malaria protozoan are related, however, Yolken and other researchers are looking among antimalarial agents for more-effective drugs to attack the cysts. But for now, medicine has no therapy to offer people who want to rid themselves of the latent infection; and until solid proof exists that Toxo is as dangerous as some scientists now fear, pharmaceutical companies don’t have much incentive to develop anti-Toxo drugs.




Yolken hopes that will change. “To explain where we are in Toxo research today,” he says, “the analogy I always give is the ulcer bacteria. We first needed to find ways of treating the organism and showing that the disease went away when you did that. We will have to show that when we very effectively treat Toxoplasma, some portion of psychiatric illness goes away.”


But T. gondii is just one of an untold number of infectious agents that prey on us. And if the rest of the animal kingdom is anything to go by, says Colorado State University’s Janice Moore, plenty of them may be capable of tinkering with our minds. For example, she and Chris Reiber, a biomedical anthropologist at Binghamton University, in New York, strongly suspected that the flu virus might boost our desire to socialize. Why? Because it spreads through close physical contact, often before symptoms emerge—meaning that it must find a new host quickly. To explore this hunch, Moore and Reiber tracked 36 subjects who received a flu vaccine, reasoning that it contains many of the same chemical components as the live virus and would thus cause the subjects’ immune systems to react as if they’d encountered the real pathogen.


The difference in the subjects’ behavior before and after vaccination was pronounced: the flu shot had the effect of nearly doubling the number of people with whom the participants came in close contact during the brief window when the live virus was maximally contagious. “People who had very limited or simple social lives were suddenly deciding that they needed to go out to bars or parties, or invite a bunch of people over,” says Reiber. “This happened with lots of our subjects. It wasn’t just one or two outliers.”


Reiber has her eye trained on other human pathogens that she thinks may well be playing similar games, if only science could prove it. For example, she says, many people at the end stages of AIDS and syphilis express an intense craving for sex. So, too, do individuals at the beginning of a herpes outbreak. These may just be anecdotal accounts, she concedes, but based on her own findings, she wouldn’t be surprised if these urges come from the pathogen making known its will to survive.
“We’ve found all kinds of excuses for why we do the things we do,” observes Moore. “‘My genes made me do it.’ ‘My parents are to blame.’ I’m afraid we may have reached the point where parasites may have to be added to the laundry list of excuses.”


She has a point. In fact, I’ve been wondering whether T. gondii might in some small way be contributing to my extreme extroversion—why I can’t resist striking up conversations everywhere I go, even when I’m short of time or with strangers I’ll never see again. Then it occurs to me that cysts in my brain might be behind my seesaw moods or even my splurges on expensive clothes. Maybe, I think with mounting conviction, the real me would have displayed better self-control, had I not been forced to swim upstream against the will of an insidious parasite. With my feline pal Pixie on my lap (for the record, she’s an outdoor cat), I call to get the results of my Toxo test. Negative. I don’t have the latent infection.

I call to tell Flegr the good news. Even though I’m relieved, I know my voice sounds flat. “It’s strange to admit,” I say, “but I think I’m a little disappointed.” He laughs. “People who have cats often feel that way, because they think the parasite explains why they behave this way or that,” he says. “But,” I protest, “you thought the same way.” Then it hits me. I may have dodged T. gondii, but given our knack for fooling ourselves—plus all those parasites out there that may also be playing tricks on our minds—can anyone really know who’s running the show?





https://www.theatlantic.com/magazine/archive/2012/03/how-your-cat-is-making-you-crazy/308873/

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How do Parasites Hijack their Host's Brains? The Neuroscience of Toxoplasmosis(弓形蟲感染症)


https://faculty.washington.edu/chudler/toxo.html


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人と動物の共通感染症に関するガイドライン
https://www.env.go.jp/nature/dobutsu/aigo/2_data/pamph/infection/guideline.pdf

トキソプラズマが人の脳を操る仕組み


http://natgeo.nikkeibp.co.jp/nng/article/news/14/7449/


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起業したい人は猫のウ●コ食べればできるかも!(良い子は真似しないように、危険です)

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[大阪]野良猫への餌やりから口論となり、同じマンションに住む男性をカッターで切りつけ。(2015/06)
[東京]野良猫に餌をあげ、隣人に注意された事に怒り果物ナイフで切りつけ。(2015/05)
[福岡]「野良猫に餌をやるな」と注意されて激怒し、57歳男性の顔面を殴る。(2014/11)
[静岡]よく公園で餌やりしていた犯人が、市主導で野良猫駆除を行っていた男性の胸倉を掴みカッターで脅す。(2011/03)
[船橋]女性から野良猫の餌やりを注意され、その帰宅を待ち伏せして包丁で刺殺。(2009/08)
[川崎]アパートの大家に餌やりを注意され逆上、大家を刺殺し義理の娘にも重症を負わせる。(2008/06)
[大阪]猫被害の苦情を言いに来たアパートの隣人を包丁で刺す。(2007/07)
[尼崎]猫の餌付けに苦情を言った人の部屋へ包丁を持って押し込み乱闘に。(2005/04)



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猫オタのロリコン勝又拓哉が2005年栃木県今市市で下校途中の7歳の女児を車で拉致して 
わいせつ行為をしたあとに胸をメッタ刺しにして殺害して雑木林に遺棄した残虐な事件 
勝又拓哉の飼っていた希少種の猫の毛が女児の遺体の付着していたことが逮捕の決め手 

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猫オタが起こした猟奇殺人事件「神戸小1女児バラバラ殺害事件」 

猫オタのロリコン君野康弘が2014.年に神戸市長田区で6歳の女児を家に連れ込んで 
殺害してわいせつ行為をした後に遺体をバラバラにしてビニール袋に入れて遺棄した残虐な事件 
君野康弘は飼ってる猫を餌に猫好き女児を家に連れ込んでいた 勝又被告、控訴審も有罪 今市事件で東京高裁 
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2005年12月、日光市(旧今市市)大沢小1年だった吉田有希ちゃん=当時(7)=が殺害された 
今市事件で、殺人罪に問われた鹿沼市西沢町、無職勝又拓哉被告(36)の控訴審判決公判が 
3日午前、東京高裁で開かれた。藤井敏明裁判長は、無期懲役を言い渡した一審宇都宮地裁の 
裁判員裁判判決を破棄したが、被告に無期懲役を言い渡した。 

https://headlines.yahoo.co.jp/hl?a=20180803-03057321-soon-l09





2018年12月30日 星期日

藥事法

藥事法

https://www.fda.gov.tw/upload/46/2013013116552772642.pdf


第 一 章
總則
第 1 條 藥事之管理,依本法之規定;本法未規定者,依其他有關法律 之規定。但管制藥品管理條例有規定者,優先適用該條例之規 定。 前項所稱藥事,指藥物、藥商、藥局及其有關事項。
 第 2 條 本法所稱衛生主管機關:在中央為行政院衛生署;在直轄市為 直轄市政府;在縣 (市) 為縣 (市) 政府。
第 3 條 中央衛生主管機關得專設藥物管理機關,直轄市及縣 (市) 衛 生主管機關於必要時亦得報准設置。
 第 4 條 本法所稱藥物,係指藥品及醫療器材
 第 5 條 本法所稱試驗用藥物,係指醫療效能及安全尚未經證實,專供 動物毒性藥理評估或臨床試驗用之藥物。
 第 6 條 本法所稱藥品,係指左列各款之一之原料藥及製劑: 一、載於中華藥典或經中央衛生主管機關認定之其他各國藥 典、公定之國家處方集,或各該補充典籍之藥品。 二、未載於前款,但使用於診斷、治療、減輕或預防人類疾病 之藥品。 三、其他足以影響人類身體結構及生理機能之藥品。 四、用以配製前三款所列之藥品。
 第 7 條 本法所稱新藥,係指經中央衛生主管機關審查認定屬新成分、 新療效複方或新使用途徑製劑之藥品。
第 8 條 本法所稱製劑,係指以原料藥經加工調製,製成一定劑型及劑 量之藥品。 製劑分為醫師處方藥品、醫師藥師藥劑生指示藥品、成藥及固 有成方製劑。 前項成藥之分類、審核、固有成方製劑製售之申請、成藥及固有成方製劑販賣之管理及其他應遵行事項之辦法,由中央衛生 主管機關定之。

第 9 條 本法所稱成藥,係指原料藥經加工調製,不用其原名稱,其摻 入之藥品,不超過中央衛生主管機關所規定之限量,作用緩 和,無積蓄性,耐久儲存,使用簡便,並明示其效能、用量、 用法,標明成藥許可證字號,其使用不待醫師指示,即供治療 疾病之用者。
第 10 條 本法所稱固有成方製劑,係指依中央衛生主管機關選定公告具 有醫療效能之傳統中藥處方調製 (劑) 之方劑。
第 11 條 本法所稱管制藥品,係指管制藥品管理條例第三條規定所稱之 管制藥品。
第 12 條 本法所稱毒劇藥品,係指列載於中華藥典毒劇藥表中之藥品; 表中未列載者,由中央衛生主管機關定之。
第 13 條 本法所稱醫療器材,係包括診斷、治療、減輕或直接預防人類 疾病,或足以影響人類身體結構及機能之儀器、器械、用具及 其附件、配件、零件。 前項醫療器材,中央衛生主管機關應視實際需要,就其範圍、 種類、管理及其他應管理事項,訂定醫療器材管理辦法規範之
 第 14 條 本法所稱藥商,係指左列各款規定之業者: 一、藥品或醫療器材販賣業者。 二、藥品或醫療器材製造業者。
第 15 條 本法所稱藥品販賣業者,係指左列各款規定之業者: 一、經營西藥批發、零售、輸入及輸出之業者。 二、經營中藥批發、零售、調劑、輸入及輸出之業者。
第 16 條 本法所稱藥品製造業者,係指經營藥品之製造、加工與其產品 批發、輸出及自用原料輸入之業者。 前項藥品製造業者輸入自用原料,應於每次進口前向中央衛生主管機關申請核准後,始得進口;已進口之自用原料,非經中 央衛生主管機關核准,不得轉售或轉讓。 藥品製造業者,得兼營自製產品之零售業務。


第 17 條 本法所稱醫療器材販賣業者,係指經營醫療器材之批發、零 售、輸入及輸出之業者。 經營醫療器材租賃業者,準用本法關於醫療器材販賣業者之規 定
第 18 條 本法所稱醫療器材製造業者,係指製造、裝配醫療器材,與其 產品之批發、輸出及自用原料輸入之業者。 前項醫療器材製造業者,得兼營自製產品之零售業務。
第 19 條 本法所稱藥局,係指藥師或藥劑生親自主持,依法執行藥品調 劑、供應業務之處所。 前項藥局得兼營藥品及一定等級之醫療器材零售業務。 前項所稱一定等級之醫療器材之範圍及種類,由中央衛生主管 機關定之
第 20 條 本法所稱偽藥,係指藥品經稽查或檢驗有左列各款情形之一 者: 一、未經核准,擅自製造者。 二、所含有效成分之名稱,與核准不符者。 三、將他人產品抽換或摻雜者。 四、塗改或更換有效期間之標示者。
第 21 條 本法所稱劣藥,係指核准之藥品經稽查或檢驗有左列情形之一 者: 一、擅自添加非法定著色劑、防腐劑、香料、矯味劑及賦形劑 者。 二、所含有效成分之質、量或強度,與核准不符者。 三、藥品中一部或全部含有污穢或異物者。四、有顯明變色、混濁、沈澱、潮解或已腐化分解者。 五、主治效能與核准不符者。 六、超過有效期間或保存期限者。 七、因儲藏過久或儲藏方法不當而變質者。 八、裝入有害物質所製成之容器或使用回收容器者。


第 22 條 本法所稱禁藥,係指藥品有左列各款情形之一者:
 一、經中央衛生主管機關明令公告禁止製造、調劑、輸入、輸 出、販賣或陳列之毒害藥品
二、未經核准擅自輸入之藥品。但旅客或隨交通工具服務人員 攜帶自用藥品進口者,不在此限。 前項第二款自用藥品之限量,由中央衛生主管機關會同財政部 公告之。
第 23 條 本法所稱不良醫療器材,係指醫療器材經稽查或檢驗有左列各 款情形之一者:
 一、使用時易生危險,或可損傷人體,或使診斷發生錯誤者。
 二、含有毒質或有害物質,致使用時有損人體健康者。
 三、超過有效期間或保存期限者。
 四、性能或有效成分之質、量或強度,與核准不符者。
 第 24 條 本法所稱藥物廣告,係指利用傳播方法,宣傳醫療效能,以達 招徠銷售為目的之行為。
 第 25 條 本法所稱標籤,係指藥品或醫療器材之容器上或包裝上,用以 記載文字、圖畫或記號之標示物。
第 26 條 本法所稱仿單,係指藥品或醫療器材附加之說明書。

第 二 章 藥商之管理

 第 27 條 凡申請為藥商者,應申請直轄市或縣 (市) 衛生主管機關核准 登記,繳納執照費,領得許可執照後,方准營業;其登記事項 如有變更時,應辦理變更登記。
前項登記事項,由中央衛生主管機關定之。 藥商分設營業處所或分廠,仍應依第一項規定,各別辦理藥商 登記。

第 27-1 條 藥商申請停業,應將藥商許可執照及藥物許可證隨繳當地衛生 主管機關,於執照上記明停業理由及期限,俟核准復業時發還 之。每次停業期間不得超過一年,停業期滿未經當地衛生主管 機關核准繼續停業者,應於停業期滿前三十日內申請復業。 藥商申請歇業時,應將其所領藥商許可執照及藥物許可證一併 繳銷;其不繳銷者,由原發證照之衛生主管機關註銷。 藥商屆期不申請停業、歇業或復業登記,經直轄市或縣 (市) 衛 生主管機關查核發現原址已無營業事實者,應由原發證照之衛 生主管機關,將其有關證照註銷。 違反本法規定,經衛生主管機關處分停止其營業者,其證照依 第一項規定辦理。
第 28 條 西藥販賣業者之藥品及其買賣,應由專任藥師駐店管理。但不 售賣麻醉藥品者,得由專任藥劑生為之。 中藥販賣業者之藥品及其買賣,應由專任中醫師或修習中藥課 程達適當標準之藥師或藥劑生駐店管理。 西藥、中藥販賣業者,分設營業處所,仍應依第一項及第二項 之規定。
第 29 條 西藥製造業者,應由專任藥師駐廠監製;中藥製造業者,應由 專任中醫師或修習中藥課程達適當標準之藥師駐廠監製。 中藥製造業者,以西藥劑型製造中藥,或摻入西藥製造中藥 時,除依前項規定外,應由專任藥師監製。 西藥、中藥製造業者,設立分廠,仍應依前二項規定辦理。
 第 30 條 藥商聘用之藥師、藥劑生或中醫師,如有解聘或辭聘,應即另 聘。


第 31 條 從事人用生物藥品製造業者,應聘用國內外大學院校以上醫藥 或生物學等系畢業,具有微生物學、免疫學藥品製造專門知 識,並有五年以上製造經驗之技術人員,駐廠負責製造。
第 32 條 醫療器材販賣或製造業者,應視其類別,聘用技術人員。 前項醫療器材類別及技術人員資格,由中央衛生主管機關定 之。
第 33 條 藥商僱用之推銷員,應由該業者向當地之直轄市、縣 (市) 衛 生主管機關登記後,方准執行推銷工作。 前項推銷員,以向藥局、藥商、衛生醫療機構、醫學研究機構 及經衛生主管機關准予登記為兼售藥物者推銷其受僱藥商所 製售或經銷之藥物為限,並不得有沿途推銷、設攤出售或擅將 藥物拆封、改裝或非法廣告之行為。 第 三 章 藥局之管理及藥品之調劑 第 34 條 藥局應請領藥局執照,並於明顯處標示經營者之身分姓名。其 設立、變更登記,準用第二十七條第一項之規定。 藥局兼營第十九條第二項之業務,應適用關於藥商之規定。但 無須另行請領藥商許可執照。
第 35 條 修習中藥課程達適當標準之藥師,親自主持之藥局,得兼營中 藥之調劑、供應或零售業務。
第 36 條 藥師親自主持之藥局,具有鑑定設備者,得執行藥品之鑑定業 務。 第 37 條 藥品之調劑,非依一定作業程序,不得為之;其作業準則,由 中央衛生主管機關定之。 前項調劑應由藥師為之。但不含麻醉藥品者,得由藥劑生為之。 醫院中之藥品之調劑,應由藥師為之。但本法八十二年二月五 日修正施行前已在醫院中服務之藥劑生,適用前項規定,並得 繼續或轉院任職。中藥之調劑,除法律另有規定外,應由中醫師監督為之。


第 38 條 藥師法第十二條、第十六條至第二十條之規定,於藥劑生調劑 藥品時準用之。

第 四 章 藥物之查驗登記

第 39 條 製造、輸入藥品,應將其成分、規格、性能、製法之要旨,檢 驗規格與方法及有關資料或證件,連同原文和中文標籤、原文 和中文仿單及樣品,並繳納費用,申請中央衛生主管機關查驗 登記,經核准發給藥品許可證後,始得製造或輸入。 向中央衛生主管機關申請藥品試製經核准輸入原料藥者,不適 用前項規定;其申請條件及應繳費用,由中央衛生主管機關定 之。 第一項輸入藥品,應由藥品許可證所有人及其授權者輸入。 申請第一項藥品查驗登記、依第四十六條規定辦理藥品許可證 變更、移轉登記及依第四十七條規定辦理藥品許可證展延登 記、換發及補發,其申請條件、審查程序、核准基準及其他應 遵行之事項,由中央衛生主管機關以藥品查驗登記審查準則定 之。
第 40 條 製造、輸入醫療器材,應向中央衛生主管機關申請查驗登記並 繳納費用,經核准發給醫療器材許可證後,始得製造或輸入。 前項輸入醫療器材,應由醫療器材許可證所有人或其授權者輸 入。 申請醫療器材查驗登記、許可證變更、移轉、展延登記、換發 及補發,其申請條件、審查程序、核准基準及其他應遵行之事 項,由中央衛生主管機關定之。
第 40-1 條 中央衛生主管機關為維護公益之目的,於必要時,得公開所持 有及保管藥商申請製造或輸入藥物所檢附之藥物成分、仿單等 相關資料。但對於藥商申請新藥查驗登記屬於營業秘密之資料,應保密之。 前項得公開事項之範圍及方式,其辦法由中央衛生主管機關定 之。


第 40-2 條 中央衛生主管機關於核發新藥許可證時,應公開申請人檢附之 已揭露專利字號或案號。 新成分新藥許可證自核發之日起五年內,其他藥商非經許可證 所有人同意,不得引據其申請資料申請查驗登記。 新成分新藥許可證核發之日起三年後,其他藥商得依本法及相 關法規有關藥品查驗登記審查之規定提出同成分、同劑型、同 劑量及同單位含量藥品之查驗登記申請,符合規定者,得於新 成分新藥許可證核發屆滿五年之翌日起發給藥品許可證。 新成分新藥在外國取得上市許可後三年內,必須向中央衛生主 管機關申請查驗登記,始得準用第二項之規定。 新藥專利權不及於藥商申請查驗登記前所進行之研究、教學或 試驗。
第 41 條 為提昇藥物製造工業水準,對於藥物科技之研究發展,得由中 央衛生主管機關會同中央工業主管機關獎勵之。 前項獎勵之資格條件、審議程序及其他應遵行事項之辦法,由 中央衛生主管機關會同中央工業主管機關定之。
第 42 條 中央衛生主管機關對於製造、輸入之藥物,應訂定作業準則, 作為核發、變更及展延藥物許可證之基準。 前項作業準則,由中央衛生主管機關定之。
第 43 條 製造、輸入藥物之查驗登記申請書及輸出藥物之申請書,其格 式、樣品份數、有關資料或證書費、查驗費之金額,由中央衛 生主管機關定之。
第 44 條 試驗用藥物,應經中央衛生主管機關核准始得供經核可之教學 醫院臨床試驗,以確認其安全與醫療效能。


第 45 條 經核准製造或輸入之藥物,中央衛生主管機關得指定期間,監 視其安全性。 藥商於前項安全監視期間應遵行事項,由中央衛生主管機關定 之。
第 45-1 條 醫療機構、藥局及藥商對於因藥物所引起之嚴重不良反應,應 行通報;其方式、內容及其他應遵行事項之辦法,由中央衛生 主管機關定之。
第 46 條 經核准製造、輸入之藥物,非經中央衛生主管機關之核准,不 得變更原登記事項。 經核准製造、輸入之藥物許可證,如有移轉時,應辦理移轉登 記。
第 47 條 藥物製造、輸入許可證有效期間為五年,期滿仍須繼續製造、 輸入者,應事先申請中央衛生主管機關核准展延之。但每次展 延,不得超過五年。屆期未申請或不准展延者,註銷其許可證。 前項許可證如有污損或遺失,應敘明理由,申請原核發機關換 發或補發,並應將原許可證同時繳銷,或由核發機關公告註銷。
第 48 條 藥物於其製造、輸入許可證有效期間內,經中央衛生主管機關 重新評估確定有安全或醫療效能疑慮者,得限期令藥商改善, 屆期未改善者,廢止其許可證。但安全疑慮重大者,得逕予廢 止之。
第 48-1 條 第三十九條第一項製造、輸入藥品,應標示中文標籤、仿單或 包裝,始得買賣、批發、零售。但經中央衛生主管機關認定有 窒礙難行者,不在此限。

第 五 章 藥物之販賣及製造

第 49 條 藥商不得買賣來源不明或無藥商許可執照者之藥品或醫療器 材。
第 50 條 須由醫師處方之藥品,非經醫師處方,不得調劑供應。但左列各款情形不在此限: 一、同業藥商之批發、販賣。 二、醫院、診所及機關、團體、學校之醫療機構或檢驗及學術 研究機構之購買。 三、依中華藥典、國民處方選輯處方之調劑。 前項須經醫師處方之藥品,由中央衛生主管機關就中、西藥品 分別定之。


第 51 條 西藥販賣業者,不得兼售中藥;中藥販賣業者,不得兼售西藥。 但成藥不在此限。 第 52 條 藥品販賣業者,不得兼售農藥、動物用藥品或其他毒性化學物 質。
第 53 條 藥品販賣業者輸入之藥品得分裝後出售,其分裝應依下列規定 辦理: 一、製劑:申請中央衛生主管機關核准後,由符合藥品優良製 造規範之藥品製造業者分裝。 二、原料藥:由符合藥品優良製造規範之藥品製造業者分裝; 分裝後,應報請中央衛生主管機關備查。 前項申請分裝之條件、程序、報請備查之期限、程序及其他分 裝出售所應遵循之事項,由中央衛生主管機關定之。
第 54 條 藥品或醫療器材經核准發給藥物輸入許可證後,為維護國家權 益,中央衛生主管機關得加以管制。但在管制前已核准結匯簽 證者,不在此限。
第 55 條 經核准製造或輸入之藥物樣品或贈品,不得出售。 前項樣品贈品管理辦法,由中央衛生主管機關定之。
第 56 條 經核准製售之藥物,如輸出國外銷售時,其應輸入國家要求證 明文字者,應於輸出前,由製造廠商申請中央衛生主管機關發 給輸出證明書。前項藥物,中央衛生主管機關認有不敷國內需要之虞時,得限 制其輸出。

第 57 條 製造藥物,應由藥物製造工廠為之;藥物製造工廠, 應依藥物製造工廠設廠標準設立,並依工廠管理輔導法規定, 辦理工廠登記。但依工廠管理輔導法規定免辦理工廠登記,或 經中央衛生主管機關核准為研發而製造者,不在此限。 藥物製造,其廠房設施、設備、組織與人事、生產、品質管制、 儲存、運銷、客戶申訴及其他應遵行事項,應符合藥物優良製 造準則之規定,並經中央衛生主管機關檢查合格,取得藥物製 造許可後,始得製造。但經中央衛生主管機關公告無需符合藥 物優良製造準則之醫療器材製造業者,不在此限。 符合前項規定,取得藥物製造許可之藥商,得繳納費用,向中 央衛生主管機關申領證明文件。 輸入藥物之國外製造廠,準用前二項規定,並由中央衛生主管 機關定期或依實際需要赴國外製造廠檢查之。 第一項藥物製造工廠設廠標準,由中央衛生主管機關會同中央 工業主管機關定之;第二項藥物優良製造準則,由中央衛生主 管機關定之。 第二項藥物製造許可與第三項證明文件之申請條件、審查程序 與基準、核發、效期、廢止、返還、註銷及其他應遵行事項之 辦法,由中央衛生主管機關定之。


第 57-1 條 從事藥物研發之機構或公司,其研發用藥物,應於符合中央衛 生主管機關規定之工廠或場所製造。 前項工廠或場所非經中央衛生主管機關核准,不得兼製其他產 品;其所製造之研發用藥物,非經中央衛生主管機關核准,不 得使用於人體。
第 58 條 藥物工廠,非經中央衛生主管機關核准,不得委託他廠製造或 接受委託製造藥物。

第 六 章 管制藥品及毒劇藥品之管理


第 59 條 西藥販賣業者及西藥製造業者,購存或售賣管制藥品及毒劇藥 品,應將藥品名稱、數量,詳列簿冊,以備檢查。管制藥品並 應專設櫥櫃加鎖儲藏。 管制藥品及毒劇藥品之標籤,應載明警語及足以警惕之圖案或 顏色。
第 60 條 管制藥品及毒劇藥品,須有醫師之處方,始得調劑、供應。 前項管制藥品應憑領受人之身分證明並將其姓名、地址、統一 編號及所領受品量,詳錄簿冊,連同處方箋保存之,以備檢查。 管制藥品之處方及調劑,中央衛生主管機關得限制之。
第 61 條 (刪除)
第 62 條 第五十九條及第六十條所規定之處方箋、簿冊,均應保存五年。
第 63 條 (刪除)
第 64 條 中藥販賣業者及中藥製造業者,非經中央衛生主管機關核准, 不得售賣或使用管制藥品。 中藥販賣業者及中藥製造業者售賣毒劇性之中藥,非有中醫師 簽名、蓋章之處方箋,不得出售;其購存或出售毒劇性中藥, 準用第五十九條之規定。


第 七 章 藥物廣告之管理


第 65 條 非藥商不得為藥物廣告。
第 66 條 藥商刊播藥物廣告時,應於刊播前將所有文字、圖畫或言詞, 申請中央或直轄市衛生主管機關核准,並向傳播業者送驗核准 文件。原核准機關發現已核准之藥物廣告內容或刊播方式危害 民眾健康或有重大危害之虞時,應令藥商立即停止刊播並限期 改善,屆期未改善者,廢止之。 藥物廣告在核准登載、刊播期間不得變更原核准事項。
傳播業者不得刊播未經中央或直轄市衛生主管機關核准、與核 准事項不符、已廢止或經令立即停止刊播並限期改善而尚未改 善之藥物廣告。 接受委託刊播之傳播業者,應自廣告之日起六個月,保存委託 刊播廣告者之姓名 (法人或團體名稱) 、身分證或事業登記證 字號、住居所 (事務所或營業所) 及電話等資料,且於主管機 關要求提供時,不得規避、妨礙或拒絕。

第 66-1 條 藥物廣告,經中央或直轄市衛生主管機關核准者,其有效期間 為一年,自核發證明文件之日起算。期滿仍需繼續廣告者,得 申請原核准之衛生主管機關核定展延之;每次展延之期間,不 得超過一年。 前項有效期間,應記明於核准該廣告之證明文件。
第 67 條 須由醫師處方或經中央衛生主管機關公告指定之藥物,其廣告 以登載於學術性醫療刊物為限。
第 68 條 藥物廣告不得以左列方式為之:
一、假借他人名義為宣傳者。 
二、利用書刊資料保證其效能或性能。
三、藉採訪或報導為宣傳。
四、以其他不正當方式為宣傳。
第 69 條 非本法所稱之藥物,不得為醫療效能之標示或宣傳。
第 70 條 採訪、報導或宣傳,其內容暗示或影射醫療效能者,視為藥物 廣告。


第 八 章 稽查及取締


第 71 條 衛生主管機關,得派員檢查藥物製造業者,販賣業者之處所設 施及有關業務,並得出具單據抽驗其藥物,業者不得無故拒 絕。但抽驗數量以足供檢驗之用者為限。 藥物製造業者之檢查,必要時得會同工業主管機關為之。

本條所列實施檢查辦法,由中央衛生主管機關會同中央工業主 管機關定之。

第 71-1 條 為加強輸入藥物之邊境管理,中央衛生主管機關得公告其輸入 時應抽查、檢驗合格後,始得輸入。 前項輸入藥物之抽查及檢驗方式、方法、項目、範圍、收費及 其他應遵行事項之辦法,由中央衛生主管機關定之。
第 72 條 衛生主管機關得派員檢查醫療機構或藥局之有關業務,並得出 具單據抽驗其藥物,受檢者不得無故拒絕。但抽驗數量以足供 檢驗之用者為限。
第 73 條 直轄市、縣 (市) 衛生主管機關應每年定期辦理藥商及藥局普 查。 藥商或藥局對於前項普查,不得拒絕、規避或妨礙。
第 74 條 依據微生物學、免疫學學理製造之血清、抗毒素、疫苗、類毒 素及菌液等,非經中央衛生主管機關於每批產品輸入或製造 後,派員抽取樣品,經檢驗合格,並加貼查訖封緘,不得銷售。 檢驗封緘作業辦法,由中央衛生主管機關定之。 前項生物藥品之原液,其輸入以生物藥品製造業者為限。
第 75 條 藥物之標籤、仿單或包裝,應依核准,分別刊載左列事項:
一、廠商名稱及地址。
二、品名及許可證字號。
三、批號。
四、製造日期及有效期間或保存期限。
五、主要成分含量、用量及用法。
六、主治效能、性能或適應症。
七、副作用、禁忌及其他注意事項。
八、其他依規定應刊載事項。
前項第四款經中央衛生主管機關明令公告免予刊載者,不在此限。


第 76 條 經許可製造、輸入之藥物,經發現有重大危害時,中央衛生主 管機關除應隨時公告禁止其製造、輸入外,並廢止其藥物許可 證;其已製造或輸入者,應限期禁止其輸出、調劑、販賣、供 應、運送、寄藏、牙保、轉讓或意圖販賣而陳列,必要時並得 沒入銷燬之。
第 77 條 直轄市或縣 (市) 衛生主管機關,對於涉嫌之偽藥、劣藥、禁 藥或不良醫療器材,就偽藥、禁藥部分,應先行就地封存,並 抽取樣品予以檢驗後,再行處理;就劣藥、不良醫療器材部分, 得先行就地封存,並抽取樣品予以檢驗後,再行處理。其對衛 生有重大危害者,應於報請中央衛生主管機關核准後,沒入銷 燬之。 前項規定於未經核准而製造、輸入之醫療器材,準用之。
第 78 條 經稽查或檢驗為偽藥、劣藥、禁藥及不良醫療器材,除依本法 有關規定處理外,並應為下列處分: 一、製造或輸入偽藥、禁藥及頂替使用許可證者,應由原核准 機關,廢止其全部藥物許可證、藥商許可執照、藥物製造 許可及公司、商業、工廠之全部或部分登記事項。 二、販賣或意圖販賣而陳列偽藥、禁藥者,由直轄市或縣(市) 衛生主管機關,公告其公司或商號之名稱、地址、負責人 姓名、藥品名稱及違反情節;再次違反者,得停止其營業。 三、製造、輸入、販賣或意圖販賣而陳列劣藥、不良醫療器材 者,由直轄市或縣(市)衛生主管機關,公告其公司或商 號之名稱、地址、負責人姓名、藥物名稱及違反情節;其 情節重大或再次違反者,得廢止其各該藥物許可證、藥物 製造許可及停止其營業。 前項規定,於未經核准而製造、輸入之醫療器材,準用之。
 第 79 條 查獲之偽藥或禁藥,沒入銷燬之。

查獲之劣藥或不良醫療器材,如係本國製造,經檢驗後仍可改 製使用者,應由直轄市或縣 (市) 衛生主管機關,派員監督原 製造廠商限期改製;其不能改製或屆期未改製者,沒入銷燬 之;如係核准輸入者,應即封存,並由直轄市或縣 (市) 衛生 主管機關責令原進口商限期退運出口,屆期未能退貨者,沒入 銷燬之。 前項規定於經依法認定為未經核准而製造、輸入之醫療器材, 準用之。

第 80 條 藥物有下列情形之一者,其製造或輸入之業者,應即通知醫療 機構、藥局及藥商,並依規定期限回收市售品,連同庫存品一 併依本法有關規定處理: 一、原領有許可證,經公告禁止製造或輸入。 二、經依法認定為偽藥、劣藥或禁藥。 三、經依法認定為不良醫療器材或未經核准而製造、輸入之醫 療器材。 四、藥物製造工廠,經檢查發現其藥物確有損害使用者生命、 身體或健康之事實,或有損害之虞。 五、製造、輸入藥物許可證未申請展延或不准展延。 六、包裝、標籤、仿單經核准變更登記。 七、其他經中央衛生主管機關公告應回收。 製造、輸入業者回收前項各款藥物時,醫療機構、藥局及藥商 應予配合。
第 81 條 舉發或緝獲偽藥、劣藥、禁藥及不良醫療器材,應予獎勵。

第 九 章 罰則

第 82 條 製造或輸入偽藥或禁藥者,處十年以下有期徒刑,得併科新臺 幣一千萬元以下罰金。 犯前項之罪,因而致人於死者,處無期徒刑或十年以上有期徒 刑,致重傷者,處七年以上有期徒刑。
因過失犯第一項之罪者,處三年以下有期徒刑、拘役或科新臺 幣五十萬元以下罰金。 第一項之未遂犯罰之。

第 83 條 明知為偽藥或禁藥,而販賣、供應、調劑、運送、寄藏、牙保、 轉讓或意圖販賣而陳列者,處七年以下有期徒刑,得併科新臺 幣五百萬元以下罰金。 犯前項之罪,因而致人於死者,處七年以上有期徒刑,致重傷 者,處三年以上十二年以下有期徒刑。 因過失犯第一項之罪者,處二年以下有期徒刑、拘役或科新臺 幣三十萬元以下罰金。 第一項之未遂犯罰之。

第 84 條 未經核准擅自製造或輸入醫療器材者,處三年以下有期徒刑, 得併科新台幣十萬元以下罰金。 明知為前項之醫療器材而販賣、供應、運送、寄藏、牙保、轉 讓或意圖販賣而陳列者,依前項規定處罰之。 因過失犯前項之罪者,處六月以下有期徒刑、拘役或新台幣五 萬元以下罰金。
第 85 條 製造或輸入第二十一條第一款之劣藥或第二十三條第一款、第 二款之不良醫療器材者,處一年以下有期徒刑或拘役,得併科 新台幣三萬元以下罰金。 因過失犯前項之罪或明知為前項之劣藥或不良醫療器材,而販 賣、供應、調劑、運送、寄藏、牙保、轉讓或意圖販賣而陳列 者,處六月以下有期徒刑或拘役,得併科新台幣一萬元以下罰 金。 因過失而販賣、供應、調劑、運送、寄藏、牙保、轉讓或意圖 販賣而陳列第一項之劣藥或不良醫療器材者,處拘役或新台幣 一萬元以下罰金。
第 86 條 擅用或冒用他人藥物之名稱、仿單或標籤者,處一年以下有期徒刑、拘役或科或併科新台幣五萬元以下罰金。 明知為前項之藥物而輸入、販賣、供應、調劑、運送、寄藏、 牙保、轉讓或意圖販賣而陳列者,處六月以下有期徒刑、拘役 或科或併科新台幣三萬元以下罰金。



第 87 條 法人之代表人,法人或自然人之代理人、受雇人,或其他從業 人員,因執行業務,犯第八十二條至第八十六條之罪者,除依 各該條規定處罰其行為人外,對該法人或自然人亦科以各該條 之罰金。
第 88 條 依本法查獲供製造、調劑偽藥、禁藥之器材,不問屬於犯人與 否,沒收之。 第 89 條 公務員假借職務上之權力、機會或方法,犯本章各條之罪或包 庇他人犯本章各條之罪者,依各該條之規定,加重其刑至二分 之一。
第 90 條 製造或輸入第二十一條第二款至第八款之劣藥或第二十三條 第三款、第四款之不良醫療器材者,處新台幣六萬元以上三十 萬元以下罰鍰。 販賣、供應、調劑、運送、寄藏、牙保、轉讓或意圖販賣而陳 列前項之劣藥或不良醫療器材者,處新台幣三萬元以上十五萬 元以下罰鍰。 犯前二項規定之一者,對其藥物管理人、監製人,亦處以各該 項之罰鍰。
第 91 條 違反第六十五條或第八十條第一項第一款至第四款規定之一 者,處新臺幣二十萬元以上五百萬元以下罰鍰。 違反第六十九條規定者,處新臺幣六十萬元以上二千五百萬元 以下罰鍰,其違法物品沒入銷燬之。
第 92 條 違反第二十七條第一項、第三項、第二十九條、第三十一條、 第三十六條、第三十七條第二項、第三項、第三十九條第一項、第四十條第一項、第四十四條、第四十五條之一、第四十六條、 第四十九條、第五十條第一項、第五十一條至第五十三條、第 五十五條第一項、第五十七條第一項、第二項、第四項、第五 十七條之一、第五十八條、第五十九條、第六十條、第六十四 條、第七十一條第一項、第七十二條、第七十四條、第七十五 條規定之一者,處新臺幣三萬元以上十五萬元以下罰鍰。 違反第五十九條規定,或調劑、供應毒劇藥品違反第六十條第 一項規定者,對其藥品管理人、監製人,亦處以前項之罰鍰。 違反第五十七條第二項或第四項規定者,除依第一項規定處罰 外,中央衛生主管機關得公布藥廠或藥商名單,並令其限期改 善,改善期間得停止其一部或全部製造、輸入及營業;屆期未 改善者,不准展延其藥物許可證,且不受理該製造廠其他藥物 之新申請案件;其情節重大者,並得廢止其一部或全部之藥物 製造許可。 違反第六十六條第一項、第二項、第六十七條、第六十八條規 定之一者,處新臺幣二十萬元以上五百萬元以下罰鍰。


第 93 條 違反第十六條第二項、第二十八條、第三十條、第三十二條第 一項、第三十三條、第三十七條第一項、第三十八條或第六十 二條規定之一,或有左列情形之一者,處新臺幣三萬元以上十 五萬元以下罰鍰: 一、成藥、固有成方製劑之製造、標示及販售違反中央 衛生主管機關依第八條第三項規定所定辦法。 二、醫療器材之分級及管理違反中央衛生主管機關依第 十三條第二項規定所定辦法。 三、藥物樣品、贈品之使用及包裝違反中央衛生主管機 關依第五十五條第二項規定所定辦法。 違反第十六條第二項或第三十條規定者,除依前項規定處罰 外,衛生主管機關並得停止其營業。


第 94 條 違反第三十四條第一項、第七十三條第二項、第八十條第一項 第五款至第七款或第二項規定之一者,處新臺幣二萬元以上十 萬元以下罰鍰。
第 95 條 傳播業者違反第六十六條第三項規定者,處新臺幣二十萬元以 上五百萬元以下罰鍰,其經衛生主管機關通知限期停止而仍繼 續刊播者,處新臺幣六十萬元以上二千五百萬元以下罰鍰,並 應按次連續處罰,至其停止刊播為止。 傳播業者違反第六十六條第四項規定者,處新臺幣六萬元以上 三十萬元以下罰鍰,並應按次連續處罰。
第 96 條 違反第七章規定之藥物廣告,除依本章規定處罰外,衛生主管 機關得登報公告其負責人姓名、藥物名稱及所犯情節,情節重 大者,並得廢止該藥物許可證;其原品名二年內亦不得申請使 用。 前項經廢止藥物許可證之違規藥物廣告,仍應由原核准之衛生 主管機關責令該業者限期在原傳播媒體同一時段及相同篇幅 刊播,聲明致歉。屆期未刊播者,翌日起停止該業者之全部藥 物廣告,並不再受理其廣告之申請。
第 96-1 條 藥商違反第四十八條之一規定者,處新臺幣六萬元以上三十萬 元以下罰鍰;其經衛生主管機關通知限期改善而仍未改善者, 加倍處罰,並得按次連續處罰,至其改善為止。 第 97 條 藥商使用不實資料或證件,辦理申請藥物許可證之查驗登記、 展延登記或變更登記時,除撤銷該藥物許可證外,二年內不得 申請該藥物許可證之查驗登記;其涉及刑事責任者,並移送司 法機關辦理。
第 97-1 條 依藥品查驗登記審查準則及醫療器材查驗登記審查準則提出 申請之案件,其送驗藥物經檢驗與申請資料不符者,中央衛生 主管機關自檢驗結果確定日起六個月內,不予受理其製造廠其他藥物之新申請案件。 前項情形於申復期間申請重新檢驗仍未通過者,中央衛生主管 機關自重新檢驗結果確定日起一年內,不予受理其製造廠其他 藥物之新申請案件。

第 98 條 (刪除)

第 99 條 依本法規定處罰之罰鍰,受罰人不服時,得於處罰通知送達後 十五日內,以書面提出異議,申請復核。但以一次為限。 科處罰鍰機關應於接到前項異議書後十五日內,將該案重行審 核,認為有理由者,應變更或撤銷原處罰。 受罰人不服前項復核時,得依法提起訴願及行政訴訟。
第 99-1 條 依本法申請藥物查驗登記、許可證變更、移轉及展延之案件, 未獲核准者,申請人得自處分書送達之日起四個月內,敘明理 由提出申復。但以一次為限。 中央衛生主管機關對前項申復認有理由者,應變更或撤銷原處 分。 申復人不服前項申復決定時,得依法提起訴願及行政訴訟。
第 100 條 本法所定之罰鍰,由直轄市、縣 (市) 衛生主管機關處罰之。
第 101 條 依本法應受處罰者,除依本法處罰外,其有犯罪嫌疑者,應移 送司法機關處理。

第 一○ 章 附則


第 102 條 醫師以診療為目的,並具有本法規定之調劑設備者,得依自開 處方,親自為藥品之調劑。 全民健康保險實施二年後,前項規定以在中央或直轄市衛生主 管機關公告無藥事人員執業之偏遠地區或醫療急迫情形為限。
第 103 條 本法公布後,於六十三年五月三十一日前依規定換領中藥販賣 業之藥商許可執照有案者,得繼續經營第十五條之中藥販賣業 務。

八十二年二月五日前曾經中央衛生主管機關審核,予以列冊登 記者,或領有經營中藥證明文件之中藥從業人員,並修習中藥 課程達適當標準,得繼續經營中藥販賣業務。 前項中藥販賣業務範圍包括︰中藥材及中藥製劑之輸入、輸出 及批發;中藥材及非屬中醫師處方藥品之零售;不含毒劇中藥 材或依固有成方調配而成之傳統丸、散、膏、丹、及煎藥。 上述人員、中醫師檢定考試及格或在未設中藥師之前曾聘任中 醫師、藥師及藥劑生駐店管理之中藥商期滿三年以上之負責 人,經修習中藥課程達適當標準,領有地方衛生主管機關證明 文件;並經國家考試及格者,其業務範圍如左︰
一、中藥材及中藥製劑之輸入、輸出及批發。
二、中藥材及非屬中醫師處方藥品之零售。
三、不含毒劇中藥材或依固有成方調配而成之傳統丸、散、膏、 丹、及煎藥。
四、中醫師處方藥品之調劑。

前項考試,由考試院會同行政院定之。



第 104 條 民國七十八年十二月三十一日前業經核准登記領照營業之西 藥販賣業者、西藥種商,其所聘請專任管理之藥師或藥劑生免 受第二十八條第一項駐店管理之限制。
第 104-1 條 前條所稱民國七十八年十二月三十一日前業經核准登記領照 營業之西藥販賣業者、西藥種商,係指其藥商負責人於七十九 年一月一日以後,未曾變更且仍繼續營業者。但營業項目登記 為零售之藥商,因負責人死亡,而由其配偶為負責人繼續營業 者,不在此限。 第 104-2 條 依本法申請證照或事項或函詢藥品查驗登記審查準則及醫療 器材查驗登記審查準則等相關規定,應繳納費用。 前項應繳費用種類及其費額,由中央衛生主管機關定之。 第 104-3 條 各級衛生主管機關於必要時,得將藥物抽查及檢驗之一部或全
部,委任所屬機關或委託相關機關(構)辦理;其委任、委託 及其相關事項之辦法,由中央衛生主管機關定之。

第 104-4 條 中央衛生主管機關得就藥物檢驗業務,辦理檢驗機構之認證; 其認證及管理辦法,由中央衛生主管機關定之。 前項認證工作,得委任所屬機關或委託其他機關(構)辦理; 其委任、委託及其相關事項之辦法,由中央衛生主管機關定之。
第 105 條 本法施行細則,由中央衛生主管機關定之。
第 106 條 本法自公布日施行。 本法中華民國八十六年五月七日修正公布之第五十三條施行 日期,由行政院定之;中華民國九十五年五月五日修正之條 文,自中華民國九十五年七月一日施行。