Exempt from the requirement

Florida, Illinois, Louisiana, Massachusetts, New Jersey, Pennsylvania, and Rhode Island (43). 1-Propanol is allowed as a flavoting substance and adjuvants according to 21 CFR 172.515 (48), and is exempted from the requirement of tolerance when used as a solvent or cosolvent iu pesticide formulations (49) (see Flavors AND spices Pesticides). 

There are a number of other scenarios where medicinal products may be brought to market exempt from the requirement to submit applications supported by full pre-dinical and clinical data. 

The schedule only provides exemptions from the requirement to hold a marketing authorisation. Other activities involved in the supply of medicines on a particular patient basis need to be carried out under the appropriate authorisations. 

Abbreviated advertisements are advertisements which are exempt from the requirement to include prescribing information for the advertised medicine, provided that they meet with the requirements of this clause. 

Exemption from the requirement of a tolerance—sodium chlorite... 

USEPA (2009) 40 CFR 180.1124. Arthropod Pheromones Exemption from the Requirement of a Tolerance. Code of Federal Regulations 40 Parts 150 to 189. Revised as of 1 July 2009. 

A pesticide tolerance is the maximum amount of a pesticide residue that can be present on food. The tolerance is expressed in ppm, or parts of the pesticide per million parts of rood by weight. A chemical generally regarded as safe need not be given a tolerance, or the chemical may be exempted from the requirement for a tolerance. This might occur when the chemical is used on nonbearing fruit trees, for example. For toxic chemicals, unified standards need to be set for raw and processed foods. 

Homeopathic drug products shall be exempt from the requirements of this section. 

Allergenic extracts that are labeled No U.S. Standard of Potency are exempt from the requirements of this section (43 FR 45077,... 

Stearic acid is derived from edible fat sources unless it is intended for external use, in which case nonedible fat sources may be used. The USPNF 23 states that stearic acid labeled solely for external use is exempt from the requirement that it be prepared from edible sources. Stearic acid may contain a suitable antioxidant such as 0.005% w/w butylated hydro-xytoluene. 

Exemption from the requirements may be requested if the method is a purification method only (MCC Circular 21/94). 

Annexure 1 Is each and every statement included in the package insert cross-referenced to the information in Annexures 13, 14 and 15 Exemption from the requirements of Annexes 14 and 15 has been requested because this product contains a well-known, well-documented, active substance. 

Certain allegations of human health and environmental adverse effects are exempt from the requirements of the TSCA Section 8(c) rule including those that (1) are made anonymously (2) identify known human effects and (3) those that are directly attributable to an incident of environmental contamination that has already been reported to the US Government under any applicable authority. 

Residues of urea are exempted from the requirement of a tolerance when used as a stabilizer, inhibitor in accordance with good agricultural practices as inert... 

In the UK in order to sell alcohol a Justice s licence is required. This normally applies to public houses, off licences, supermarkets, etc. A pharmacy would need a licence in order to retail an alcoholic tonic wine but does not need a licence in order to supply or manufacture medicines containing alcohol. A pharmacy would also be exempt from the requirement to hold a licence if selling alcohol to a trader for purposes of trade. 

The legal basis for an IND was set up in the 1962 amendments. It is unlawful to transport an unapproved drug across state lines unless FDA has issued an exemption. The IND is technically an exemption from the requirements of an NDA. Dmgs labeled Not for human use are also exempt from the NDA requirements, before being transported, but carry regulatory restrictions. Note that technically and legally these regulations apply just as much to noncommercial research physicians, for example in universities, as to pharmaceutical companies. 

Small installations in the US SO2 program are generally exempt from the requirement to install a Continuous Emissions Monitoring System and instead report emissions based on fuel use and engineering calculations. 

In contrast with the position of the manufacturer involved in particular patient supply, section 35(2) of the Act currently exempts from the requirement to hold a manufacturer s licence the manufacturer or assembler of products for the sole purpose of clinical trial use. 

EPA. 1993a. Exemptions from the requirement of a tolerance. Chemicals affected by standards of performance for volatile organic compound emmisions from synthetic organic chemical manufacturing industry reactor process. Environmental Protection Agency. Code of Federal Regulations. 40 CFR 60.707. 

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