No person shall compound, or sell or offer for sale, or cause to be compounded, sold or offered for sale any medicine or preparation under or by a name recognized in the United States Pharmacopoeia National Formulary, for internal or external use, which differs from the standard of strength, quality or purity as determined by the test laid down in the United States Pharmacopoeia National Formulary official at the time of such compounding, sale or offering for sale. Nor shall any person compound,
This Act shall be known and may be cited as the Illinois Food, Drug and Cosmetic Act. 410 ILCS 620/1 Laws 1967, p. 959.
Except as set forth in Section 26 of the Pharmacy Practice Act, this Section does not prohibit the interchange of different brands of the same generically equivalent drug product, when the drug products are not required to bear the legend "Caution: Federal law prohibits dispensing without prescription", provided that the same dosage form is dispensed and there is no greater than 1% variance in the stated amount of each active ingredient of the drug products. A generic drug determined to be therapeutically
The purpose of this Act is to implement the Federal Prescription Drug Marketing Act of 1987 (PDMA), U.S. Pub. L. 100-293, 102 Stat. 95, codified at U.S.C. Sec. 321 et seq.; and particularly PDMA requirements that no person or entity may engage in the wholesale distribution of human prescription drugs in any state unless the person or entity is licensed by that state in accordance with federally prescribed minimum standards, terms, and conditions as set forth in guidelines issued by United States
The definitions contained in § 314.3 of this chapter apply to those terms when used in this part. 21 C.F.R. §320.1 81 FR 69658, Oct. 6, 2016 81 FR 69658, 12/5/2016
(a)Definitions. The definitions in § 314.3 and the following definitions of terms apply to this section: Approved under section 505(b) means an NDA submitted under section 505(b) and approved on or after October 10, 1962, or an application that was "deemed approved" under section 107(c)(2) of Public Law 87-781 . Bioavailability study means a study to determine the bioavailability or the pharmacokinetics of a drug. Clinical investigation means any experiment other than a bioavailability study in which