Unauthorized Manufacture

It is recommended that unauthorized manufacture should not be a criminal offense unless it is done with purpose to sell or otherwise dispose of a controlled drug. Illicit manufacturers usually manufacture depressant or stimulant drugs to distribute them. However, some controlled drugs may be made on a small scale for personal use. Thus, it 

6) A State might impose criminal sanctions, for example, unauthorized manufacture, prescription, sale, purchase, or possession of narcotics within its borders. 370 U.S. at 664. 

10) Statement of Comm r Goddard before the Subcommittee on Executive Reorganization of the Senate Committee on Government Operations, May 24, 1966 see note 191 supra.  

---

It is also recommended that unauthorized manufacture of a controlled substance drug should not be the subject of a criminal prohibition under a model act unless it is committed with a purpose to sell or otherwise dispose of such a drug. When it is not committed with such a purpose it may appropriately be a civil violation. 

It is recommended that unauthorized manufacture should not btj criminal offense unless it is done with purpose to sell or otherwl dispose of a controlled drug. Illicit manufacturers usually manufactu depressant or stimulant drugs" to distribute them. However, so controlled drugs may be made on a small scale for personal use. Thus is possible that some individuals may be making LSD solely for th own use. Many of the same reasons which support the exemption persons who without authorization possess controlled drugs solely fi their own use from criminal liabifity also support their exempt from criminal liability for unauthorized manufacture. Even more th possession, unauthorized manufacture is an offense preparatory... 

Verify the proportions of the components in the mix to be sure they are those specified by the manufacturer, and measured as specified by weight, and that the mix is properly trowelable-neither too "soupy" nor too stiff." Do not rely on or accept the assurances of the mechanics for this. Do not permit the addition of any unauthorized material to the mix. Verify that speed of all power mixers is not more than 350 rpm. 

Where a clinical trial is proposed with a marketed product, then the applicant can submit a copy of the trial protocol, provide information on the investigators and, depending on whether or not the applicant is the MA holder, information on the procedures for reporting adverse drug reactions (ADRs). It is only possible to use this procedure for United Kingdom marketed drugs. It does not apply to unauthorized products manufactured specifically for trial, nor to products which may be licensed in other countries but are not in receipt of a MA in the United Kingdom. 

A scheme has been proposed for using the neutrons from the fusion reaction to convert uranium 238 to plutonium 239 or thorium 232 to uranium 233 for the manufacture of bombs. While in theory this may be possible, it does not appear to offer an easier route to the produetion of bombs than the current methods of separation of uranium 235, or the production of plutonium in a conventional reactor. As a result of these factors, use of a fusion energy system will in no way add to the potential for further nuclear weapons or provide a source for the unauthorized procurement of materials that might be used to produce weapons. 

Pharmaceuticals and medical preparations manufacturing premises should maintain records concerning the distribution of a drug. These records should be presented to Ministry inspectors whenever deemed necessary in order to enable them to investigate on whether sales are affected to unauthorized or persons. 

The security function usually includes fire prevention and reporting, crime prevention and detection, risk management, and administration of security personnel. A security survey should be taken to determine the scope of the security function, the condition of this service, and the steps necessary to bring security up to standmd. Outside gumds may be necessary to prevent unauthorized entry to critical manufacturing areas, laboratories, computer rooms, and other sensitive areas. The level of security depends on the sensitivity emd confidentiality of the work, the labor situation, the local crime situation, and the proximity of fire and police protection (Piper 1988b). 

In Jnne 2013, the FDA recommended that medical device manufacturers and healthcare facilities take steps to assnre that appropriate safeguards reduce the risk of failure due to cyber-attack, which could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks. Many medical devices contain confignrable embedded compnter systems that can be vulnerable to cybersecurity breaches. In addition, as medical devices become increasingly interconnected, via the Internet, hospital networks, other medical device, and smartphones, there is an increased risk of cybersecurity breaches, which could affect how a medical device operates. Recently, the FDA has become aware... 

Containers or valves should never be altered or repaired by unauthorized personnel. Use only reducing valves and gaskets designed for chlorine. Consult the chlorine manufacturer for details. The Chlorine Institute has compiled industry recommendations for chlorine tank cars in Pamphlet 66, Chlorine Tank Car Loading, Unloading, Air Padding, Hydrostatic Testing [12]. 

In the case of nanotechnology, mask works may be added to this list. If chip layout information is novel in design, it can be proteded to prevent unauthorized copying. The PTO issues three types of patents (a) utility patents for any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof (b) plant patents for any distinct and new variety of plant and (c) design patents for any new, original and ornamental design for an article of manufacture. Note that this chapter focuses solely on U.S. utility patents. 

Explosives and fuze safety is the process used to prevent premature, unintentional, or unauthorized initiation of explosives and devices containing explosives and to minimize the effects of explosions, combustion, toxicity, and any other deleterious effects. Explosives safety includes all mechanical, chemical, biological, electrical, and environmental hazards associated with explosives or EM environmental effects. Equipment, systems, or procedures and processes whose malfunction would cause unacceptable mishap risk to manufacturing, handling, transportation, maintenance, storage, release, testing, delivery, firing, or disposal of explosives are also included. 

Put up signs in the lab, warehouse, and manufacturing areas that state these locations are off-limits to unauthorized personnel (one needs an escort, pass, or key to enter). 

No special provisions are normally necessary for the control of public exposure, as the facility shielding will ensure that exposures outside the premises are below the reference levels specified by the regulatory body and members of the public are not expected to have access to the facihty. Control measures for occupational exposure will usually be adequate to ensure that exposure rates at locations accessible to the public are sufficiently low, but this should be confirmed. Access control should be maintained to protect against unauthorized access to the irradiation facility. Irradiation sources should be disposed of by returning them to the manufacturer, supplier or similar authorized recipient. In most circumstances the manufacturer or supplier will be involved directly in source replacement and loading, and will also take away the used sources. 

Many clinical trials have been undertaken on the crude extracts and pure compounds derived from this genus plants. For instance, products developed from bark and other parts of U. tomentosa have been commercially available in the form of nutraceutical supplements. For instance in Austria, preparations from root are accepted for the prescription for rheumatoid arthritis. However, unauthorized products are being used worldwide without appropriate Good Manufacturing Practice. For this reason, the Council of Experts of the United States Pharmacopeial Convention prepared a monograph on the U. tomentosa in order to establish specifications for further improvement in the quality of nutraceutical supplements in this country. Further research and implementation of the regulations for safe practices would lead to potential use of Uncaria spp. as therapeutic agents. 

---