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Pharmacy Laws .

QuestionAnswer
1906 FFDA prohibit the sale of mislabeled or adulterated food, drinks and drugs.
1914 HNA limit the transport of opium. purchased opium need prescription
1938 FD&CA Gives FDA more comprehensive to include cosmetic. Defines mislabeled or adulterated drugs to be illegal. Requires companies to include package insert. drug habit forming to be labeled "maybe habit forming" and new drugs must be proven safe by fDa
1951 DHA distinguish legend prescription drugs and otc drugs. req. company to label legen drugs (clue caution: " ").physician supervision. Otc needs to have label of: package drug,name and address of manufacture and all active or non ingredient.
1962 KHA all drugs frm 1938 needs to be proven safe and effective. due to birth defect (thalidomide in europe). req. gmp. all manufacture are inspect every 2 yrs. register annually. report any adverse reaction.
1970 CDAP&CA Drug enforcement agency
1970 PPPA childproof packaging. exempt in emergency "nitroglycerin" and package that comes w/ small qnty wouldn't harm children under 5.
1983 ODA enable fda to promote research and marketing treatment for rare disease.
2006 CMEA limit the purchase of pse to 3.6 g per day to 9g per 30 days.
package insert accutane, oral contraceptive, ,metered inhaler, estrogen containing and progestational and I. contraceptive device.
NDC manufacturer,drug,p. size. five first set are (m) four set middle are (d) and last two are the size.
Class 1 Class 2 Class 3 Class 4 Class 5 mescaline, lsd rf 0 require dea 222 fentanyl,methylphenadite,secobarbita rf 5 to 6 antidiarrhea with codeine,antissusive with codeine anabolic steroid, cough syrup rf 5 to 6 mo phenobarbital,diethylpropion
Orange Book therapeatic equivalency using an alphabetical rating system. A can be substitue because they are bioequivalent and b can not bec. they are not bioequivalent. published yrly.
USP/NF contains monograph and chemical characteristic. Has three volume. volume 1 for healhtcare provider volume 11 for patients volume 111 for therapeutic = info and pharmacy law
Created by: Poison
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